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Chiropractic Research-Chronic Pain A compilation of research Related Primarily to Chronic pain and spinal manipulation Submitted by: Ronald J. Farabaugh, D.C. The Problem… Generally, although the profession, the public, and other health professionals need guidance, as a rule we have few problems with treatment associated with acute pain or acute episodes of chronic pain. Acute pain patients are usually treated and released with a minimal of controversy. The majority of patients suffering chronic pain are treated effectively in episodes/bursts of care. However a subset of chronic pain sufferers exist who require ongoing “supportive care”, i.e., schedule ongoing care, often at 1-2 visits per month. This is the same population of patients ingesting large amounts of drugs and often managed, or miss-managed, in pain management centers across the nation. A Message to the Profession concerning literature related to chronic pain. Obviously limited quality literature exists related to the issue of supportive care dosage, etc. At the same time enough research has been published of mixed quality to rationally justify the use of spinal manipulation, in addition to other types of intervention, for chronic pain sufferers. No singular treatment intervention has superior footing in terms of research related to chronic pain management. In today’s society chronic pain management is a team sport, and chiropractic should assume its rightful place on the “team”. Available Topics…. Chronic pain Cost Studies Drug Issues Diagnostic Test Accuracy Etiology of Pain Whiplash Soft tissue healing Recurrent nature of pain Pain vs. Function Spinal Manipulation The Neurological Basis for Chronic Pain Two important studies… Spine 2004; 29(2):182-188 Characterization of Acute Whiplash-Associated Disorders. Sterling, PhD, et al. Conclusions. Acute whiplash subjects with higher levels of pain and disability were distinguished by sensory hypersensitivity to a variety of stimuli, suggestive of central nervous system sensitization occurring soon after injury. These responses occurred independently of psychological distress. These findings may be important for the differential diagnosis of acute whiplash injury and could be one reason why those with higher initial pain and disability demonstrate a poorer outcome. Evidence for spinal cord hypersensitivity in chronic pain after whiplash injury and in fibromyalgia. Banic B, et al. Pain; 2004 Jan;107(1-2) p7 - 15 Patients with chronic pain after whiplash injury and fibromyalgia patients display exaggerated pain after sensory stimulation. Because evident tissue damage is usually lacking, this exaggerated pain perception could be explained by hyperexcitability of the central nervous system. We provide evidence for spinal cord hyperexcitability in patients with chronic pain after whiplash injury and in fibromyalgia patients. This can cause exaggerated pain following low intensity nociceptive or innocuous peripheral stimulation. Spinal hypersensitivity may explain, at least in part, pain in the absence of detectable tissue damage. Maintenance and Supportive Care Studies “Maintenance Care: Health Promotion Services Administered to US Chiropractic Patients Aged 65 and Older, Part II”, Rupert, Manello, Sandefur, JMPT, Vol 23, No. 1, January 2000, pp. 10-19. · Objective: Obtain information regarding multiple health issues of patients age 65 and over who have had a long-term regimen of chiropractic health promotion and preventive care. Design: 65 years +, “health promotion and prevention services” for at least 5 years @ min. of 4/yr, used SF-36D survey, 73 DCs, tx not just CMT, stretching exercise (68.2%), aerobics (55.6%), dietary advice (45.3%), and a host of other prevention strategies, including vitamins and relaxation. o 16.95 visits to DC/yr vs. 4.76 visits/yr to MD. Maintenance Care (Rupert study), cont’d. Results: DC avg. only $3,106 which is 31% lower of the national average healthcare costs for the same age group. DC avg is lower than the national avg. for US citizens Of all ages, which was $3,510. Pts. Receiving maintenance DC spent an avg. of $1,723 for hospitalizations. The per capita expenditures for Medicare hospitalization was $5,121 or 51% of the total cost of health care services. Maintenance Care (Rupert study), cont’d. Conclusions: • DC visits 2x vs. MDs, but 50% reduction in # of MD visits. •Therefore, DC treatment “replaces”, not compliments, MD care. • Extreme differences in Hospitalization costs. • “Total annual cost of health care services for the patient receiving MC was conservatively 1/3 of the expense made by US citizens of the same age.” Chiropractic Patients in a Comprehensive Home-Based Geriatric Assessment, Followup and Health Promotion Program, Coulter, Hurwitz, Aronow, Cassata, Beck, Top Clin Chiro 1996; 3(2):46-55, 1996 Purpose: To assess characteristics of older patients who seek chiropractic care. Methodology: A detailed examination of a database collected during a randomized clinical trial testing the effectiveness of a comprehensive geriatric assessement program was performed. 3 year randomized trial, 75 years of age and older. Results: Sample size of 414, with 23 receiving chiropractic care. DC users were: Less likely to have been hospitalized Less likely to have used a nursing home More likely to report a better health status, More likely to exercise vigorously More likely to be mobile in the community Less likely to use prescription drugs Conclusion: Results suggest a need to develop chiropractic models that address the special preventive and rehabilitative needs of the older patient. Chiropractic maintenance care and quality of life of a patient presenting with chronic low back pain. Wenban AB, Nielsen MK. J Manipulative Physiol Ther. 2005 Feb;28(2):136-42. Objective To report on a 26-year-old female patient presenting with uncomplicated chronic low back pain who received chiropractic maintenance care using 2 quality of life outcome assessment instruments. Outcome measures Short-form (SF-36) subscales, Quality of Well-Being Scale, Visual Analog Scale, and number of tender vetebral spinous processes. Conclusion The patient appeared to experience improvement in quality of life while showing signs suggestive of improved spinal function. The relationship between indicators of vertebral subluxation and quality of life deserves further investigation using a research design that allows for exploration of possible causal relationships. Efficacy of preventive spinal manipulation for chronic low-back pain and related disabilities: a preliminary study. Descarreaux M, Blouin JS, Drolet M, Papadimitriou S, Teasdale N. J Manipulative Physiol Ther. 2004 Oct;27(8):509-14. Related Articles, Links OBJECTIVE: To document the potential role of maintenance chiropractic spinal manipulation to reduce overall pain and disability levels associated with chronic low-back conditions after an initial phase of intensive chiropractic treatments. METHOD: 2 groups; (1) 12 tx in 1 mo., no tx for 9 mo. (2) 12 tx in 1 mo., 1 tx every 3 weks for 9 mo. RESULTS: Both groups maintained their pain scores at levels similar to the postintensive treatments throughout the follow-up period. For the disability scores, however, only the group that was given spinal manipulations during the follow-up period maintained their postintensive treatment scores. The disability scores of the other group went back to their pretreatment levels. CONCLUSIONS: Intensive spinal manipulation is effective for the treatment of chronic low back pain. This experiment suggests that maintenance spinal manipulations after intensive manipulative care may be beneficial to patients to maintain subjective postintensive treatment disability levels. Spinal Manipulation Literature Related to Chronic pain Woodward, Cook, et al. (1996). “Chiropractic Treatment of Chronic Whiplash.” Injury 27 (9): 643-5 “The accumulated literature suggests that 43% of patients will suffer long-term symptoms following ‘whiplash’ injury. If patients are still symptomatic after 3 months then there is almost a 90% chance that they will remain so. No conventional treatment has proven to be effective in these established chronic cases.” “The results of this retrospective study would suggest that benefits can occur in over 90% of patients undergoing chiropractic treatment for chronic ‘whiplash’ injury.” Following the chiropractic treatment, 93% of the patients had improved. A Symptomatic Classification of Whiplash Injury and the Implications for Treatment. Khan, Cook, Gargan, and Bannister, University Department of Orthopaedic Surgery, Bristol, UK. The Journal of Orthopaedic Medicine 21[1]1999. Objective: To determine which patients with chronic whiplash will benefit from chiropractic treatment. 93 patients, 68 female. Conclusion: Whiplash injuries are common. Chiropractic is the only proven effective treatment in chronic cases. Our study enables patients to be classified at initial assessment in order to target those patients who will benefit from such treatment. 57% make full recovery. Resolution of symptoms will have occurred within 2 years of injury. 8% will remain disabled by their symptoms. Khan, Cook, Gargan, and Bannister, University Department of Orthopaedic Surgery, Bristol, UK. The Journal of Orthopaedic Medicine 21[1]1999. (cont’d) Non-responders do exist. Defining characteristics include: full range of motion in association with neck pain, bizarre symptoms, female sex and ongoing litigation. McNab, found that symptoms persist in 45% of patients two years after settlement of litigation. Watkinson et al, found significantly higher frequency of degenerative changes on radiological examination of patients who have sustained soft tissue injuries than in a controlled population, place more emphasis on the organic basis of symptoms. Khan, Cook, Gargan, and Bannister, University Department of Orthopaedic Surgery, Bristol, UK. The Journal of Orthopaedic Medicine 21[1]1999. (cont’d) Whilst other studies have suggested that neurological signs (Group 2) have a poorer prognosis, this was not the case amongst our patients. Indeed, such patients showed the greatest improvement in disability grade. Group 1: Neck pain, restricted ROM, no neurological deficit. Group 2: Neurological symptoms, neck pain, restricted motion. Group 3: Severe neck pain, full ROM, no neurological symptoms. Results: Organic pain causes psychological stress, not the result of it! CHIROPRACTIC MORE EFFECTIVE THAN MEDICAL CARE FOR LBP; JMPT – March 2004;27:160-9. Investigators pooled data on 60 chiropractic patients from 51 chiropractic clinics and 11 patients cared for by general practitioners from 14 medical clinics. All subjects had acute or chronic LBP. Findings showed that chiropractic care had significant advantages over medical care. Specifically, “a clinically important advantage for chiropractic patients was seen in chronic patients in the short-term (>10 [visual analog scale] points), and both acute and chronic chiropractic patients experienced somewhat greater relief up to 1 year.” Patients with leg pain below the knee appeared to have the greatest advantage from chiropractic care. “Study findings were consistent with systematic reviews of the efficacy of spinal manipulation for pain and disability in acute and chronic LBP,” write the study’s authors. “Patient choice and interdisciplinary referral should be prime considerations by physicians, policymakers and third-party payers in identifying health services for patients with LBP.” Meade Study: BMJ 1990 A British ten year study concluded that chiropractic treatment was significantly more effective, particularly with patients with chronic and severe pain Bronfort, DC et al. JMPT 1996 “For the management of chronic back pain, trunk exercise in combination with manipulation or NSAIDs seems beneficial and worthwhile.” Giles LG, Muller R. JMPT 1999 Study compared spinal manipulation, needle acupuncture, and NSAIDs for the treatment of chronic back pain. After 30 days, spinal manipulation was the only intervention to achieve statistically significant improvement. Intervention by way of acupuncture or NSAIDs did not result in significant improvements in any of the outcome measures. Manual Medicine 1986 CMT is both subjectively and objectively, more effective at relieving low back pain than a manual placebo treatment. SPINE 1997 Maurits W. van Tulder, et al “…strong evidence for the effectiveness of manipulation, back schools, and exercise therapy for chronic low back pain, especially for short term results.” Additionally, the study found that no single therapeutic intervention was demonstrated to be effective in the treatment of chronic LBP. SPINE 1995 Triano, McGregor, et al “There appears to be clinical value to treatment according to a defined plan using manipulation even in low back pain exceeding 7 weeks’ duration” Chronic Spinal Pain: A Randomized Clinical Trial Comparing Medication, Acupuncture, and Spinal Manipulation. Spine July 15, 2003; 28(14):1490-1502 Design: RCT, 115 patients, public hospitals multidisciplinary spinal pain unit. Evaluated at 2, 5, and 9 weeks. Manipulation performed by DCs with 18 adjustments or less. Drugs used; Celebrex, Vioxx, paracetamol. Average duration of spine pain was 8.3 years for the manipulation group. Results: The highest proportion of early (asymptomatic status) recovery was found for manipulation (27.3%), followed by acupuncture (9.4%) and medication (5%). Conclusions: The consistency of the results provides evidence that in patients with chronic spinal pain, manipulation, if not contraindicated, results in greater short-term improvement than acupuncture or medication. Bronfort. DC et al. JMPT 1996; 19(9): 570-582 This was a randomized controlled study with a one year follow-up in 174 chronic low back pain patients (age 20-60) that compared the efficacy of five weeks of: (1) spinal manipulation (SM) with trunk strengthening exercises (TSE); (2) SM combined with trunk stretching exercises; and (3) NSAIDs with TSE all followed by 6 weeks of supervised exercise alone. Bronfort. DC et al. JMPT 1996; 19(9): 570-582 (cont’d) Results: Outcomes at 5 and 11 weeks revealed no significant group differences. Continuance of exercise during the followup year, regardless of the type of treatment, was associated with a better outcome. Conclusion: All three treatment regimens were associated with similar and clinically important improvement over time and the treatment was considered superior to the expected natural history of long-standing chronic low back pain. For the management of chronic low back pain, trunk exercise in combination with spinal manipulation or NSAIDs seems beneficial and worthwhile. Dabbs, D.C. and Lauretti, D.C., A Risk Assesment of Cervical Manipulation vs. NSAIDs for the Treatment of Neck Pain. Journal of Manipulative and Physiological Therapeutics. Vol. 18, number 8 Oct. 1995; 18:530-6. “The best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. There is no evidence that indicates NSAID use is any more effective than cervical manipulation for neck pain.” Death rate for NSAID-associated GI problems at 0.04% per yr amoung OA patients receiving NSAIDs, or 3,200 deaths in the US per year. He (Brandt) also noted that there are several animal studies and human clinical studies that have actually implicated NSAIDs in the acceleration of joint destruction. Hoving et al. A Randomized Controlled Trial of Manual Therapy. Ann Intern Med. 2002;136:713-722. Manual Therapy, Physical Therapy, or Continue Care by a General Practitioner for Patients with Neck Pain, A Randomized, Controlled Trial., Pages 713-722 Intervention: 6 weeks of manual therapy (specific mobilization techniques) once per week, physical therapy (exercise therapy) twice per week, or continued care by a general practitioner (analgesics, counseling, and education). “Conclusion: In daily practice, manual therapy is a favorable treatment option for patients with neck pain compared with physical therapy or continued care by a general practitioner.” Osteopathic Manipulation No Better Than Sham Therapy for Chronic Back Pain. Spine: July 8, 2003. July 8, 2003 — Osteopathic manipulation is no better than sham therapy for chronic nonspecific low back pain, according to the results of a randomized trial published in the July issue of Spine. However, both osteopathic and sham manipulation were more effective than no therapy. Efficacy of spinal manipulative therapy for low back pain of less than three months' duration. JMPT November/December 2003. Volume 26 . Number 9. Review of the literature. Ferreira et al. Conclusions: Spinal manipulative therapy produces slightly better outcomes than placebo therapy, no treatment, massage, and short wave therapy for nonspecific low back pain of less than 3 months duration. Spinal manipulative therapy, exercise, usual physiotherapy, and medical care appear to produce similar outcomes in the first 4 weeks of treatment. The Journal of Neurological and Orthopaedic Medicine and Surgery. An article entitled, Effective Management of Spinal Pain in 200 Patients Evaluated for Manipulation Under Anesthesia Volume 17,No 1, 1998. "In completing this study, the authors found that a multidisciplinary approach to evaluation and treatment offers patient benefits above and beyond that which can be obtained through the individual providers working alone. It is our intention to proceed with studies of a more specific design as this present work has demonstrated positive results and no complications." The New England Journal of Medicine 1999;341:1426-1431, 1465-1467. Osteopaths equal MDs at relieving chronic back pain NEW YORK, Nov 03 (Reuters Health) -- Manual therapy by an osteopath is as effective at relieving chronic lower back pain as traditional medical care, according to a report in the November 4th issue of The New England Journal of Medicine. Results of a study from Chicago researchers showed patients who received osteopathic therapy for subacute low back pain received fewer drugs and needed less physical therapy than those treated with standard care. Reminder: DC’s provide 94% of all manipulation performed. RAND. Randomized Osteopathic Manipulation Study (ROMANS): Pragmatic Trial for Spinal Pain in Primary Care. Wilkinson C, et al. Family Practice 2003. Dec;20(6):662-9 CONCLUSION: A primary care osteopathy clinic improved shortterm physical and longer term psychological outcomes, at little extra cost. Rigorous multicentre studies are now needed to assess the generalizability of this approach. Reminder: DC’s provide 94% of all manipulation performed. RAND. Spinal manipulation effective for low back pain. Strickland. The Journal of family practice.; 2003 Dec;52(12) p925 - 929 Spinal manipulation, usual care with analgesics, physical therapy, exercises, and "back school" all provide similar results when used for treatment of both acute and chronic low back pain. Clinicians may wish to treat patients with low back pain themselves or refer them for chiropractic care, physical therapy, or back schools. This decision should be based on patient preferences after reviewing relative risks and benefits. A recent systematic review of alternative therapies for low back pain reported similar effects from spinal manipulation and massage therapy. The effectiveness of acupuncture in the management of low back pain remains unclear. Bronfort et al. Trunk Exercise Combined with Spinal Manipulation or NSAID Therapy for Chronic Low Back Pain: A Randomized, Observer-Blinded Trial. JMPT. Vol. 19. Number 9. Nov/Dec. 1996. Results: There seemed to be a sustained reduction in medication use at the 1-year follow-up in the SMT/TSE group. Continuance of exercise during the follow-up year, regardless of type, was associated with a better outcome. Conclusion: For the management of CLBP, trunk exercise in combination with SMT or NSAID therapy seemed to be beneficial and worthwhile. Cox et al. Distraction Manipulation Reduction of an L5-S1 Disk Herniation . Journal of Manipulative and Physiological Therapeutics Volume 16, Number 5, June, 1993 Conclusions: Chiropractic distraction manipulation is an effective treatment of lumbar disk herniation, if the chiropractor is observant during its administration for patient tolerance to manipulation under distraction and any signs of neurological deficit demanding other types of care. BenEliyahu et al. Magnetic Resonance Imaging and Clinical Follow-up: Study of 27 Patients Receiving Chiropractic Care for Cervical and Lumbar Disc Herniations. JMPT. Volume 19, Number 9, November/December, 1996 Results: Clinically, 80% of the patients studied had a good clinical outcome with post-care visual analog scores under 2 and resolution of abnormal clinical examination findings. Anatomically, after repeat MRI scans, 63% of the patients studied revealed a reduced size or completely resorbed disc herniation. There was a statistically significant association (p, .005) between the clinical and MRI follow-up results. Seventyeight percent of the patients were able to return to work in their pre-disability occupations. Conclusion: This prospective case series suggest that chiropractic care may be a safe and helpful modality for the treatment of cervical and lumbar disc herniations. A random, controlled, clinical trial is called for to further substantiate the role of chiropractic care for the non-operative clinical management of intervertebral disc herniation. Cassidy et al. Side Posture Manipulation for Lumbar Intervertebral Disk Herniation. JMPT. Volume 16, Number 2, February, 1993 Conclusions: The treatment of lumbar intervertebral disk herniation by side posture manipulation is both safe and effective. Cassidy et al. Cont’d Points of Interest: Normal disks withstood an average of 22.6 degrees of rotation before failure, while the degenerated disks withstood an average of 14.3 degrees. When disk failure occurred, it presented as peripheral annular tears and not herniation or prolapse. Posterior facet joints of the intact lumbar motion segment allow only a small range of rotation at the lower levels. Therefore torsional failure of the lumbar disk first requires fracture of the posterior joints, which can then result in peripheral annular tears. Bottom line: The bony architecture of the lumbar spine prevents excess rotation that would have damaged the peripheral annular fibers. Therefore it remains unlikely that side posture spinal manipulation would damage a disk. Waagen et al. Short term trial of chiropractic adjustments for the relief of chronic low back pain. Manual Medicine (1986) 2:63-67 After two weeks of treatments the experimental patients as a group exhibited significant overall pain relief (+2.3), whereas improvement of patients in the control group was not significant (+0.6). Troyanovich et al. JMPT. Vol. 21, Number 1, January 1998. Structural Rehabilitation of the Spine and Posture: Rationale for Treatment Beyond the Resolution of Symptoms. Conclusion: Because mechanical loading of the neuromusculoskeletal tissues plays a vital role in influencing proper growth and repair, chiropractic rehabilitative care should focus on the normalization/minimization of aberrant stresses and strains acting on spinal tissues. Manipulation alone cannot restore body postures or improve an altered sagittal spinal curve. Therefore, postural chiropractic adjustments, active exercises and stretches, resting spinal blocking procedures, extension traction, and ergonomic education are deemed necessary for maximal spinal rehabilitation. Croft et al. Outcome of low back pain in general practice: a prospective study. BMJ Volume 316; 2 May 1998. Conclusions: The results are consistent with the interpretation that 90% of patients with low back pain in primary care will have stopped consulting with symptoms within three months. However most will still be experiencing low back pain and related disability one year after consultation. Shekelle et al. Congruence between Decisions To Initiate Chiropractic Spinal Manipulation for Low Back Pain and Appropriateness Criteria in North America. Annals of Internal Medicine, 1 July 1998. 129:9-17. Conclusions: The proportion of chiropractic spinal manipulation judged to be congruent with appropriateness criteria is similar to proportions previously described for medical procedures; thus, the findings provide some reassurance about the appropriate application of chiropractic care. However, more than one quarter of patients were treated for indications that were judged inappropriate. The number of inappropriate decisions to use chiropractic spinal manipulation should be decreased. Mooney. Why Exercise for Low Back Pain? Activity Reverses Biochemical Changes Caused by Injury. The Journal of Musculoskeletal Medicine. October 1995. Selected statements: There is no evidence that a diagnosis-or even the presence or absence of a neurologic deficit-can predict the duration or outcome of a back problem. Concerning exercise and AHCPR Guidelines: The guidelines are nonspecific and contain no rationale. In all other soft-tissue injuries, progressive physical activity evacuates extracellular, extravascular fluid. This justifies the recommendation of early mobility for injured tissues. The early motion should be gentle but progressive, with the expectation that gradually increasing stresses will facilitate healing. Koes, et al. A Randomized Clinical Trial of Manual Therapy and Physiotherapy for Persistent Back and Neck Complaints: Subgroup Analysis and Relationship Between Outcome Measures. JMPT; 16:211219; 1993. Results: Greater improvement in the main complaint was associated with manual therapy than with physiotherapy for patients with back problems of 1 year’s duration or longer. For patients younger than age 40 years, improvement was also greater with manual therapy than with physiotherapy. Conclusion: Manual therapy appears to yield better results than physiotherapy in patients with chronic conditions, and in patients younger than age 40 years. Davis. Chronic Cervical Spine Pain Treated With Manipulation Under Anesthesia. Journal of the Neuromusculoskeletal System. Fall 1996 Vol. 4, No. 3. The results suggest that manipulation under anesthesia may be beneficial in patients with chronic pain that effects work or activities of daily living and in patients with cervical segmental dysfunction, fibrosis, myofascitis, or cervicogenic headaches. Licciardone et al. Osteopathic Manipulative Treatment for Chronic Low Back Pain. Spine. 2003;28:1355-1362. Conclusion: Osteopathic Manipulative Treatment (OMT) and sham manipulation, both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific LBP. It remains unclear whether the benefits of OMT can be attributed to the manipulative techniques themselves or whether they are related to other aspects of OMT, such as range of motion activities or time spent interacting with the patient, which may represent placebo effects. Quon et al. Lumbar Intervertebral Disc Herniation: Treatment by Rotational Manipulation. Journal of Manipulative and Physiological Therapeutics, Volume 12, Number 3, June, 1989. Although caution must be exercised in interpreting single case studies, this paper describes a patient who presented with an L4-L5 disc herniation. The size of the lesion revealed by CT examination was so great that one would not expect a favorable response to conservative measures. However, the patient was rendered pain-free within 2 weeks by daily manipulations. The enormous size of the disc herniation did not seem to influence the clinical result. Had a trial of conservative therapy not been prescribed, he may well have undergone an unnecessary surgical procedure. Furthermore, a repeat CT scan, 4 months after the initial episode, showed no change in the size or position of the disc herniation. Miscellaneous Literature Providing a Rationale Basis for a Consensus Statement Concerning Supportive Care of Chronic Pain Conditions “Passive” or “No lasting therapeutic Benefit” or “Non-Curative” or “Palliative” What treatment can survive a requirement suggesting that treatment must provide curative or long lasting therapeutic benefit? ANSWER: NONE! Chiropractic or Osteopathic manipulation Drugs Physical Therapy (electric stim, ultrasound, ice, heat, etc.) Massage Epidural injections Facet Injections Physical Rehabilitation Exercises Patient Education NSAIDs Surgery Criteria: Minimal requirements to qualify for Chronic Pain Management. 1. 2. 3. 4. 5. 6. Unable to attain pre-accident status; attained maximal therapeutic benefit; recovered with residual soft tissue damage Therapeutic withdrawal attempted Unable to maintain improvement Minimal tx recommended Dx & Tx alternatives considered Home management recommended Goals of Chiropractic Spinal Manipulation for Chronic Pain 1. 2. 3. 4. Pain Relief Improve Fx Decrease Reliance on drugs Keep the patient employed What Are The Negative Effects of Joint Immobilization? Liebenson C: Pathogenesis of Chronic Back Pain. JMPT 15:303, 1992 Joints Shrinks joint capsules Increases compressive loading Leads to joint contracture Increases synthesis rate of glycosaminoglycans Increase in periarticular fibrosis Irreversible changes after 8 weeks of immobilization Ligament Lowers failure or yield point Decreased thickness of collagen fibers What Are The Negative Effects of Joint Immobilization? Liebenson C: Pathogenesis of Chronic Back Pain. JMPT 15:303, 1992 (cont’d) Disk Biochemistry · · · · · Decreases oxygen Decreases glucose Decreases sulfate Increases lactate concentration Decreases proteoglycan content Bone · · Decreases bone density Eburnation What Are The Negative Effects of Joint Immobilization? Liebenson C: Pathogenesis of Chronic Back Pain. JMPT 15:303, 1992 (cont’d) Muscle Decreased thickening of collagen fibers Decreased oxidative potential Decreased muscle mass Decreased sarcomeres Decreased cross-sectional area Decreased mitochondrial content Increased connective tissue fibrosis Type 1 muscle atrophy Type 2 muscle atrophy 20% loss of muscle strength per week What Are The Negative Effects of Joint Immobilization? Liebenson C: Pathogenesis of Chronic Back Pain. JMPT 15:303, 1992 (cont’d) Cardiopulmonary Increased maximal heart rate Decreased VO2 max Decreased plasma volume What Are The Positive Effects of Spinal Manipulation and Joint Mobility? Nelson, DC. Top Clin Chiro 1994;1(4):20-29. Stretching of abnormally tight tissues (passive forcing) Increased range of motion Selective tearing of adhesions without damaging healthy tissue Stimulation of wound healing Improved edema removal due to pumping action of movement Removal of waste products & chemical mediators of pain Increased fluid flows, discal & cartilage nutrition What Are The Positive Effects of Spinal Manipulation and Joint Mobility? Nelson, DC. Top Clin Chiro 1994;1(4):20-29. Reduction of the pain-spasm cycle Increase of mechanoreceptive input due to increased motion Close the “gate” to the central transmission of pain Regeneration of functional tissue & less scarring Improved rate & endpoint of tissue healing Movement is a specific stimulus for collagen production Movement increases cellular metabolism & protein synthesis What Are The Positive Effects of Spinal Manipulation and Joint Mobility? Nelson, DC. Top Clin Chiro 1994;1(4):20-29. Improved ligament strength Improved matrix organization Proper alignment of new collagen Normalize proprioceptive patterns from joints & muscles Normalize coordinated complimentary motor programs Miscellaneous Literature Adjustments Don’t Have to Make Noise to Work. Archives of Physical Medicine and Rehabilitation – July 2003;84:1057-60. “There is no relationship between an audible pop during SI region manipulation and improvement in ROM, pain, or disability in individuals with non-radicular LBP. Additionally, the occurrence of a pop did not improve the odds of a dramatic improvement with manipulation treatment.” Doctors of Chiropractic More Qualified Than Osteopaths, PTs and MDs in Spinal Manipulation/Adjustment, According to American Chiropractic Association. Arlington, Va., Nov. 4 /PRNewswire * A survey of osteopathic schools found that most schools generally offer spinal manipulation/adjustment only on an elective basis. * No manipulation/adjustment training is given or available for M.D.s in medical school curricula. * One study queried 10 physical therapy schools -- none taught spinal manipulation/adjustment. "Individuals with less training and expertise than doctors of chiropractic may provide outcomes that are less than optimal, and can pose unnecessary health and safety risks and possible complications for patients," the policy statement reads. Exercise? Is it a cure-all? Several studies compared McKenzie (exercises) protocols with spinal manipulation. Wiesel, MD (Cherkin, PhD) McKenzie Protocol versus Chiropractic Care for LBP. Backletter 1995:10(11):121, 130, 131. And Wiesel, MD. (Cherkin, PhD) Mckenzie versus Manipulation. Back letter 1996;11(12)Dec: 133, 139. Exercise “McKenzie and spinal manipulation were equivalent in symptoms, function, disability, and satisfaction, and were superior to booklet in terms of symptoms and satisfaction. However, McKenzie did not reduce recurrences or long-term utilization of health care.” In other words, exercise is no cure in and of itself for the treatment of low back pain. Chronic Back Pain Survey “Survey: Chronic back pain sufferers prefer drug-free pain management.” ACA press release. 8/20/2004 71% had suffered chronic LBP for 5 years or more. 84.6% had suffered back pain for a minimum of 3 years. Most common remedy…drugs…41% reported back pain was “not under control”, or “not under control at all”. 64.4% would consider consulting a DC for LBP. 80.3% would prefer to avoid the use of medication. Highest income respondents were the group least likely to prefer using medications for their back pain. Observation: DC profession must do a better job of promoting itself as a provider of safe, natural, drug-free methods of pain relief…and not just for back pain. Wiberg et al. The Short-term Effect of Spinal Manipulation in the Treatment of Infantile Colic: A randomized Controlled Clinical Trial with a Blinded Observer. Journal of Manipulative and Physiological Therapeutics Volume 22, Number 8, October 1999. Results: By trial days 4 to 7, hours of crying were reduced by 1 hour in the dimethicone group compared with 2.4 hours in the manipulation group (P=.04). On days 8 through 11, crying was reduced by 1 hour for the dimethicone group, whereas crying in the manipulation group was reduced by 2.7 hours (P=.004). From trial day 5 onward the manipulation group did significantly better than the dimethicone group. Conclusion: Spinal manipulation is effective in relieving infantile colic. Reed et al. Chiropractic Management of Primary Nocturnal Enuresis. JMPT, Volume 17, Number 9, November/December, 1994 Results: The post-treatment mean wet night frequency of 7.6 nights/2 wk for the treatment group was significantly less than its baseline mean wet night frequency of 9.1 nights/2 wk (p = 0.05). For the control group, there was practically no change (12.1 to 12.2 nights/2 wk) in the mean wet night frequency from the baseline to the post-treatment……… Twenty-five percent of the treatment-group children had 50% or more reduction in the wet night frequency from baseline to post-treatment while none among the control group had such reduction. Conclusion: Results of the present study strongly suggest the effectiveness of chiropractic treatment for primary nocturnal enuresis. Maigne et al. Highlighting of Intervertebral Movements and Variations of Intradiskal Pressure During Lumbar Spine Manipulation: A Feasability Study. JMPT Vol. 23, Number 8, October 2000. Even though this study was a limited one on cadavers, it has important implications: - Spinal manipulation is capable of lowering intradiscal pressure, a phenomenon thought to improve related symptoms. - This pressure change theory is consistent with outcome studies that have examined manipulation in the treatment of symptomatic disc herniation. - Vertebral movement can be demonstrated during manipulation. - The effect of this movement is to redistribute or normalize intradiscal pressure, not to result in a different resting position of the vertebra. - Future work on the motion/position aspect of manipulation should look at temporary positional changes during the manipulation, not before and after position. Maigne et al. Cont’d Conclusion: Lumbar spinal manipulations have a biomechanical effect on the IVD, producing a brief but marked change in intradiskal pressure. This effect, which differs slightly with the different types of manipulation studied, is the consequence of movements of the adjacent vertebrae. Chiropractic management of chronic chest pain using mechanical force, manually assisted short-lever adjusting procedures. Polkinghorn BS, Colloca CJ. J Manipulative Physiol Ther. 2003 Feb;26(2):108-15 OBJECTIVE: To discuss a case involving a patient with chronic chest pain, dyspnea, and anxiety. Although resistant to previous treatment regimens, the condition responded favorably to chiropractic manipulation of the costosternal articulations. METHODS: 49 year old male, chronic chest pain for 4 months, Activator instrument, RESULTS: After 14 weeks of care, complete resolution of chronic pain, maintained at 9 month follow-up, CONCLUSIONS: Certain types of chest pain may have their etiology in a subluxation complex involving the costosternal articulation. ….. a musculoskeletal involvement, including costosternal subluxation complex, may be the underlying cause of the symptoms in certain patients. When this is the case, chiropractic adjustment may provide an effective mode of treatment. Chiropractic high-velocity low-amplitude spinal manipulation in the treatment of a case of postsurgical chronic cauda equina syndrome. Lisi AJ, Bhardwaj MK. J Manipulative Physiol Ther. 2004 Nov-Dec;27(9):574-8. OBJECTIVE: To present an evidence-based case report on the use of chiropractic high-velocity lowamplitude spinal manipulation in the treatment a postsurgical, chronic cauda equina syndrome patient. METHODS: 35 yr old female, presents with CES, duration of symptoms-6 months-post surgical for acute CES secondary to HNP; symptoms considered to be residual and non-progressive. INTERVENTION AND OUTCOME: Pt. Tx with HVLA CMT and ancillary myofascial release. After 4 treatments, the patient reported full resolution of midback, low back, and buttock pain. The patient was seen another 4 times with no improvement in her neurologic symptoms. No adverse effects were noted. CONCLUSION: This appears to be the first published case of chiropractic high-velocity low-amplitude spinal manipulation being used for a patient with chronic cauda equina syndrome. It seems that this type of spinal manipulation was safe and effective for reducing back pain and had no effect on neurologic deficits in this case. Nonoperative treatments for sciatica: a pilot study for a randomized clinical trial.Bronfort G, Evans RL, Anderson AV, Schellhas KP, Garvey TA, Marks RA, Bittell S. J Manipulative Physiol Ther. 2000 Oct;23(8):536-44. Related Articles, Links OBJECTIVES: To assess the feasibility of patient recruitment, the ability of patients and clinicians to comply with study protocols, and the use of data collection instruments to collect cost-effectiveness data, and to obtain variability estimates for sample-size calculations for a full-scale trial. PATIENTS: Ages 20 to 65 years, with low back-related radiating leg pain (sciatica), tx with Medical care, chiropractic care, and epidural steroid injections. OUTCOME MEASURES: Self-report questionnaires were administered at baseline and 3 and 12 weeks after randomization. RESULTS: A total of 706 persons were screened by phone to determine initial eligibility. Of these, over 90% of those persons contacted did not meet the entrance criteria. The most common reason for disqualification was that the duration of the complaint was longer than 3 months. CONCLUSIONS: Pilot studies such as these are important for the determination of the feasibility of conducting costly, larger scale trials. Recruitment for a full-scale study of sciatica of 2 to 12 weeks duration is not feasible. Vernon et al. Spinal Manipulation and Headaches of Cervical Origin. Journal of Manipulative and Physiological Therapeutics, Volume 12, Number 6, December, 1989. ABSTRACT: The role of the cervical spine in headache remains controversial. Often confused as tension or common migraine headache, headaches arising from the neck pose a diagnostic and therapeutic challenge. Recent writers addressing this issue, including Bogduk (2-4), Edmeads (50, Farina et al. (6) and Sjaastad and his colleagues (7-9), have added much to our current understanding. However, even these authors appear to have included only a small portion of the supportive literature in their reports, leaving a diminished sense of the historical attention and the current clinical importance of this category of headaches. Chiropractic Cost Related Literature and Information Cost Issues What is the financial impact of Chiropractic Healthcare? What is the impact of medical errors and drug shadow costs? Research… oldies but goodies! A review of past literature. Topic: Bed Rest Waddell. A New Clinical Model for the Treatment of Low-Back Pain. Spine. 1987;12:632-644 Little scientific or clinical evidence supports the value of bed rest. Only four controlled studies Bed rest is the most harmful treatment ever devised and a potent cause of iatrogenic disease. Topic: Bed Rest AHCPR. Lee. Publication No. 95-0643; December 1994, pp. 2. Extended bed rest could be harmful. Resting in bed for more than 4 days can weaken muscles and bones and delay recovery. RAND Study Shekelle, et al. “The Appropriateness of Spinal Manipulation for Low Back Pain: Indication and Ratings by a Multidisciplinary Expert Panel.” 1991; RAND/UCLA Monograph No. R-4025/2CCR/FCER. “Spinal manipulation is the most commonly used conservative treatment for back pain supported by the most research evidence of effectiveness in terms of early results and long-term effectiveness.” 2/3 of patient visits were to chiropractic providers for a total cost of $2.4 billion in 1988. Conversely, 1/3 of the visits for back pain were to medical providers (MD) for a total cost of $8 billion. 94% of manipulation is performed by doctors of chiropractic. AHCPR Acute Low Back Problems in Adults: Assessment and Treatment Proven Initial Care: Patient education, patient comfort (NSAIDs), and SPINAL MANIPULATION. Unproven Therapies: Traction, physical modalities (massage, diathermy, US, cutaneous laser, biofeedback, TENS, acupuncture, trigger point injections, facet injections, steroid or lidocaine injections, shoe lifts, exercise machines, stretching. Harmful treatment: Best Rest. Utah Study Jarvis, et al. Cost per Case Comparison of Back Injury Claims of Chiropractic Versus Medical Management for Conditions with Identical Diagnostic Codes. Journal of Occupational Medicine. 1991; Vol. 33, No. 8, Aug., pp. 847-851. In 3,062 separate cases: Chiropractic care took an active approach with 8 times more visits. Medical care took a passive approach prescribing medication and rest. Utah Study (cont’d) Conclusion: Chiropractic care was 73% more cost-effective per case. The average distribution cost per office visit was 67% less for chiropractic than for the medical office visit. Patients seeing doctors of chiropractic were able to return to work 10 times sooner than those under medical care. For the total data set, cost for care was significantly more for medical claims—Compensation costs were ten-fold less for chiropractic claims. Australian Study Ebrall. Mechanical Low Back Pain: A Comparison of Medical and Chiropractic Management Within the Victorian WorkCare Scheme. Chiropractic Journal of Australia. 1992; Vol. 22, No. 2, June pp. 47-53 Compensation days with Chiropractic management are ¼ the days of claims with medical management. The “occurrence of chronicity” was greater with medical management (6 fold greater progression to chronicity-11.6% to 1.9%). Cost of claims: $2,038 Medical/$963 Chiropractic. Average compensation payment is 4 times greater with medical management. Australian Study (cont’d) Conclusion: Financial and social savings could be maximized by: Increased participation rate by DCs in the WorkCare. Increased early referral from medical doctors to Chiropractic doctors. British Study Meade, et al. Low Back Pain of Mechanical Origin. Randomized Comparison of Chiropractic and Hospital Outpatient Treatment. BMJ. 1990; Vol. 303, No. 6737. June pp. 1431-1437 10 year multicenter trial. Conclusion: Chiropractic treatment was significantly more effective, particularly with patients with chronic and severe pain. Results were long-term throughout the two-year follow up period. The potential economic, resources, and policy implications of the results were extensive. Patients treated by Chiropractors…almost certainly fared considerably better and maintained their improvement for at least two years. Canadian Study Manga et al. The Effectiveness and Cost Effectiveness of Chiropractic Management of Low-Back Pain. Manga Report to Ontario Ministry of Health. August, 1993. Conclusions: The “Constellation of evidence” demonstrates: The treatment effectiveness and cost effectiveness of Chiropractic care. The untested, questionable, or harmful nature of many current medical therapies. The economic efficiency of Chiropractic care versus medical care. The safety of Chiropractic. Higher patient satisfaction. Canadian Study Manga (cont’d) Summary: There should be a shift in policy to encourage the utilization of chiropractic services for most patients with back pain… A very good case can be made for making chiropractors the gatekeepers for management of low-back pain the worker’ compensation system. Virginia Study Schifrin. Mandated Health Insurance Coverage for Chiropractic Treatment: An Economic Assessment with Implications for the Commonwealth of Virginia. January, 1992 “By every test of cost-effectiveness, the general weight of evidence shows that Chiropractic provides important therapeutic benefits at economical costs.” “These benefits are achieved with minimal, even negligible, impact on the costs of health insurance.” “Chiropractic services are widely used and appreciated by a growing segment of Americans.” 2nd Virginia Study Dean, et al. “A Comparison of the Cost of Chiropractors versus Alternative Medical Practitioners.” Virginia Chiropractic Association. January 1992. “Chiropractors see their patients more frequently but have lower overall costs for most of the conditions considered.” “Chiropractic care requires fewer referrals for specialists and outside procedures.” “If Chiropractic care is insured to the same extent as other specialties, it may result in a decrease in overall treatment costs for neuro-musculoskeletal conditions.” Medstat Project Stano et al. MEDSTAT Data Base Review. The Journal of American Health Policy. 1992; Vol. 2 #6. Conclusions: Plans which have limited or no chiropractic coverage have the highest total costs per patient. Broader coverage of chiropractic services results in dramatically lower health care cost as follows: 35% lower hospital admission rates. 42% lower inpatient payments. 23% lower total health care costs. US General Accounting Office “Access to Health Insurance: State Efforts to Assist Small Business.” GAO-92-90; May 1992; pg. 33 “Mandates determined not to add significantly to the cost of health insurance include services for in-vitro fertilization, acupuncture, and cleft palate, as well as services provided by Chiropractors and home health nurses. It is these low cost mandates, however that are often cited by the business community as examples of the added wasteful expense mandates cause for business.” Journal of American Health Policy Stano et al. “The Growing Role of Chiropractic in Health Care Delivery.” Journal of American Health Policy. 1992 Nov-Dec. pp. 39-45. “Plans which do not cover Chiropractic have the highest payments per patient.” “Increased availability of demonstrated cost-effective alternatives would increase access and would reduce costs.” Journal of Family Practice Cherkin et al. “Family Physicians, Chiropractors, and Back Pain.” The Journal of Family Practice. 1992; Vol. 35, No. 5, pp. 551-555 Chiropractic doctors are well-trained and well-accepted by both patients and insurers. Western Journal of Medicine Cherkin et al. “Patient Evaluation of Low Back Pain Care from Family Physicians and Chiropractors.” Western Journal of Medicine. 1989; Vol. 150, No. 3, March pp. 351-355. Conclusion: Chiropractic doctors were highly rated compared to medical doctors in critical patient care areas for the treatment of low back pain. Patients gave DCs a 3:1 advantage in five important areas of patient satisfaction. Chiropractic patients reported quicker recoveries. British Medical Journal Smith. “Where is the Wisdom? The Poverty of Medical Evidence.” BMJ. 1991; Vol. 303, October pp. 798-799. “Only about 15% of medical interventions are supported by valid medical evidence…Many treatments have never been assessed at all.” Recent studies… A review of the literature. “DC’s as Primary Care Providers” (Interview with James Zechman, Part 1, condensed summary) Editor’s note: In the December 1, 1999 issue, we interviewed the CEO of Alternative Medicine, Inc. (AMI), James Zechman. AMI had contracted with Blue Cross/ Blue Shield of Illinois, the state’s largest managed care plan, to give its more than 700.000 enrolled members the option of having AMI’s chiropractors as their primary care physicians. The following interview highlights were reported in the February 12, 2001issue of Dynamic Chiropractic. Zeckman (cont’d) Our theory was to accurately test a preventive health care system based on a non-pharmaceutical/nonsurgical entry point. We have no limit on the number of visits, treatments or procedure. Anything which takes place within the doctor’s own office is unencumbered. Zeckman (cont’d) Waiting to see a physician until disease is present adds costly tests, procedures and pharmaceuticals to health care bill that could have been avoided through a strong and integrated preventive care program. We believe this is the only rational choice: to create a true prevention-based health care system as opposed to after-thefact disease care system. It is this system of truly integrated medicine that precludes the need for restrictive guidelines and disruptive oversight of chiropractic care. We believe once you identify quality- the rest takes care of itself. Zeckman…The Results Compared to normative values in the greater Chicago area for all other allopathic IPA’s our network has reduced hospitalizations by approximately 60 percent over a 24-month consecutive period. We have reduced outpatient surgery and procedures by approximately 85 percent over a 24- month consecutive period. We have reduced pharmaceutical usage by approximately 56 percent over a 24-month consecutive period. Of interest to note is that we have no C-section deliveries over a two-year period, as compared to a network average of over 22 percent. Zeckman…Conclusion AMI’s primary care chiropractors are showing the world what the profession has always believed since its inception: Chiropractic has an ability to impact a person’s health in a very profound manner. Mosley, Cohen, DC, Arnold, MD. American Journal of Managed Care 1996;2:280-282. Retrospective study of patients at an independent physician model HMO in Louisiana evaluating cost of care for acute low back pain or neck pain for patients who sought chiropractic care or other treatment. Also looked at surgical rates, use of diagnostic imaging (MR and CT) and patient satisfaction on claims paid Oct. 1, 1994 – Oct. 1, 1995. Mosley, Cohen, DC, Arnold, MD. American Journal of Managed Care 1996;2:280-282. Results: Cost of care for BP and NP was substantially lower for DC patients than non-DC patients. Use of prescription drugs and diagnostic imaging were significantly greater in non-DC group whereas surgical rates and patient satisfaction were nearly identical. Conclusion: DC care outcomes are equal to those of non-DC care at substantially lower costs. MD patients got 2x as many prescriptions. Study demonstrates that DC services were well integrated in an HMO and has proven satisfactory to patients and providers as well as costeffective for BP and NP. The system offered self-referral for DC services. Mosley, Cohen, DC, Arnold, MD. American Journal of Managed Care 1996;2:280-282. If half of the patients treated by traditional care received DC care, annual savings would have exceeded $215,000. We recommend its wider application by the managed care industry and physician community. [Emphasis Added.] Muse Study\Medicare The Muse study compared the most recently available CMC Medicare cost and utilization data for those beneficiaries that received chiropractic care versus those beneficiaries that only received traditional medical care. The Muse study found that the global per capita Medicare expenditures for chiropractic patients were significantly lower than the same costs for non-chiropractic patients. Muse Study\Medicare (cont’d) The Muse study concluded, "Chiropractic care significantly reduces per beneficiary costs to the Medicare program. The results of the study suggests that chiropractic services could play a role in reducing costs Medicare reform and/or a new prescription drug benefit." Comparative Analysis of Individuals With and Without Chiropractic Coverage Patient Characteristics, Utilization, and Costs. Legorreta, Metz, Nelson, Ray, Chernicoff, DiNubile, MD Arch Intern Med. 2004;164:1985-1992. Methods: A 4-year retrospective claims data analysis comparing more than 700,000 health plan members with an additional chiropractic coverage benefit and 1 million members of the same health plan without the chiropractic benefit. Results: Members with chiropractic insurance coverage, compared with those without coverage, had lower annual total health care expenditures ($1463 vs $1671 per member per year, P<.001). Less total annual health care costs at the health plan level. Lower utilization (per 1000 episodes) of plain radiographs Less low back surgery Less hospitalizations Less magnetic resonance imaging. Lower average back pain episode–related costs ($289 vs $399, P<.001). “Chiropractic Care: is it substitution care or add-on care in corporate medical plans?” Metz, et al. J. Occupational Environmental Medicine. 2004;46:847-855. The results “indicate that patients use chiropractic care as a direct substitute for medical care.” 4 year study: 1997-2001 Not a survey….used actual claims data. 1,394,070 patients; 174,209 were DC pts; 332,548 were medical pts; 887,313 were medical pts w/o DC coverage. Results: nearly half chose DC care when offered a choice. “Within a MC setting, the inclusion of a DC benefit does not increase the overall rates of pt. complaints….pts appear to be directly substituting DC care for medical care”. “An Evaluation of Medical and Chiropractic Provider Utilization and Costs: Treating Injured Workers in North Carolina JMPT September 2004 • Volume 27 • Number 7 Shawn P. Phelan, DC, Richard C. Armstrong, DC, David G. Knox, DC, Michael J. Hubka, DC, Dennis A. Ainbinder, MD Objective: To examine utilization, treatment costs, lost workdays, and compensation paid workers with musculoskeletal injuries treated by medical doctors (MDs) and doctors of chiropractic (DCs). Design: Retrospective review of 96,627 claims between 1975 and 1994. Results Average cost of treatment, hospitalization, and compensation payments were higher for patients treated by MDs than for patients treated by DCs. Average number of lost workdays for patients treated by MDs was higher than for those treated by DCs. Combined care patients generated higher costs than patients treated by MDs or DCs alone. Conclusion These data, with the acknowledged limitations of an insurance database, indicate lower treatment costs, less workdays lost, lower compensation payments, and lower utilization of ancillary medical services for patients treated by DCs. Despite the lower cost of chiropractic management, the use of chiropractic services in North Carolina appears very low. Drug Issues Miscellaneous Literature Gurkirpal Singh, George Triadafilopoulos, Epidmiology of NSAID induced gastrointestinal complications. J. Rheumatol 1999, Apr;26 Suppl 56:18-24. Department of Medicine, Division of Immunology, Stanford University School of Medicine, Palo Alto, California 94304, USA. NSAIDs are one of the most commonly used classes of medications worldwide. 30 million people take NSAIDs daily. GI complications are the most prevalent category of adverse drug reactions. Patients with arthritis are the most frequent users, therefore at greater risk. NSAID related deaths among patients with RA and OA are even more startling. It is conservatively estimated that 16,500 NSAID-related deaths occur in these patients every year in the US. 15th most common cause of death in the US. Stats DO NOT include nonarthritis indications. Wolfe, M.D., Lichtenstein, M.D., Singh, M.D. Gastrointestinal Toxicity of Nonsteroidal Antiinflamatory Drugs. The New England Journal of Medicine, June 17, 1999, Review Article, Medical Progress. 113 References. NSAID agents constitute one of the world’s most widely used classes of drugs, with more than 70 million prescriptions and more than 30 billion over-thecounter tablets sold annually in the US. “Although the annual mortality rate is low, it must be emphasized that because a large number of patients are exposed to NSAIDs often for extended periods of time, the risk over a lifetime is substantial.” Hospitalization due to GI complications 103,000/yr. Estimated cost $15,000 to $20,000 per hospitalization. Annual cost exceeds $2 Billion. “It has been estimated conservatively that 16,500 NSAID-related deaths occur among patients with RA and OA every year in the US.” Wolfe, M.D., Lichtenstein, M.D., Singh, M.D. Gastrointestinal Toxicity of Nonsteroidal Antiinflamatory Drugs. The New England Journal of Medicine, June 17, 1999, Review Article, Medical Progress. (cont’d) Doses of aspirin as low as 30 mg are sufficient to suppress prostaglandin synthesis in the gastric mucosa initiating gastric-duodenal mucosal injury, resulting in the release of oxygen-derived free radicals. Peptic ulcers-gastroduodenal hemorrhage-perforation-death! Acetaminophen is nontoxic to the GI mucosa, however, recall that acetaminophen is a leading cause of end-stage renal disease. Cox-2 inhibitors will hopefully have a reduced capacity to cause injury to the gastroduodenal mucosa. However, Cox-2 inhibitors are also known to cause defects in renal function, alter the regulation of bone resorption, impair female reproductive physiology, and increase the rate of thrombotic events in patients with increase risk for cardiovascular disease. Dabbs, D.C. and Lauretti, D.C., A Risk Assesment of Cervical Manipulation vs. NSAIDs for the Treatment of Neck Pain. Journal of Manipulative and Physiological Therapeutics. Vol. 18, number 8 Oct. 1995; 18:530-6. “The best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. There is no evidence that indicates NSAID use is any more effective than cervical manipulation for neck pain.” Death rate for NSAID-associated GI problems at 0.04% per yr amoung OA patients receiving NSAIDs, or 3,200 deaths in the US per year. He (Brandt) also noted that there are several animal studies and human clinical studies that have actually implicated NSAIDs in the acceleration of joint destruction. OxyContin U.S. News and World Report, July 2, 2001 “Not an appropriate use”, “Did the makers of OxyContin push too hard?” Virginia residents filed a $5.3 billion class action lawsuit that alleges Pharma also failed to disclose the drug’s risks, setting off a wave of OxyContin addiction and abuse. Associated deaths jumped 93% between 1997 and 1998. DEA reported 291 deaths in just 6 states. NUTLEY, N.J. (July 15) - Mother's little helper is not so little anymore. Valium, the drug that revolutionized the treatment of anxiety and became a cultural icon, is 40 years old this year. Invented by chemist Leo Sternbach Approved for use in 1963, became the country's most prescribed drug from 1969 to 1982. The Roche Group, Hoffman-La Roche's parent, sold nearly 2.3 billion pills stamped with the trademark ``V'' at its 1978 peak. Baycol-Cholesterol drug The Columbus Dispatch, August 9, 2001 “Bayer pulls medicine tied to 31 U.S.Deaths” Baycol has been linked to significantly more fatal cases than its competitors, Dr. John Jenkins of the FDA Other drugs include Lescol, Lipitor, Mevacor, Pravachol, Zocor Baycol-Cholesterol drug “Every statin has been linked to very rare reports of the muscle side effect called rhabdomyolysis.” Baycol is the 12th prescription drug taken off the market since 1997. Allergy Pills Overused Study out of OSU, reported in Columbus Dispatch, Monday, April 9, 2001 Of 246 North Carolina residents taking prescription antihistamines, blood tests showed 65 percent didn’t have allergies. Skill testing unreliable vs. Blood tests “Side Effects: As Drug-Sales Teams Multiply, Some Doctors Shut Them Out” Wall Street Journal, 6-13-03 “’Arms Race’ by Pfizer, Rivals Boost Pill Prices and Ire, But No One Dares Retreat.” “Free Tacos and Piles of Bextra” 90,000 drug industry reps $12 Billion spent on sales force $2.76 billon on consumer drug ads. Result: Prescriptions up 14% to $161 Billion spent on drugs in 2002!!!! Unnecessary Mastectomies BMJ March 4, 2000 1997 pathologist Professor Kemnitz made numerous false positive diagnoses of breast cancer. 300 women suffered mastectomies Professor Kemnitz committed suicide, set himself on fire and destroyed evidence in his lab. Wall street journal,4/22/03 Page 1, section d Saying No to the Knife... Apparently, research now shows that surgery for back problems, gum disease, hernias, sinus problems, and injured kidneys, to name a few, are not necessary much of the time. And the effects of the surgery are apparently often worse than the condition treated. Antibiotics and Breast Cancer February 17, 2004 JAMA The longer that women took the drugs, and the more prescriptions they took, the greater their risk of breast cancer. Aspirin in Gastric Ulcer 76 year old women NEJM Levy MD, Vol. 343 Number 12 400 mg. Etodolac 2x/day for RA 1 tablet of enteric-coated aspirin / day 1 mg. of warfarin sodium per day Endoscopy revealed aspirin tablet intact with an ulcer of gastric antrum. Continuous Low-Level Heat Wrap Therapy Provides More Efficacy Than Ibuprofen and Acetaminophen for Acute Low Back Pain Scott F. Nadler, DO, et al. SPINE 2002;27:1012-1017 Conclusion. Continuous low-level heat wrap therapy was superior to both acetaminophen and ibuprofen for treating low back pain. Muscle Relaxants “Muscle Relaxants: Overused, Ineffective and Acute LBP” Bernstein E, Carey TS, Mills Garrett J. The use of muscle relaxant medications in acute low back pain. Spine 2004;29(12):1346-51. Cohort of 1600..MC-LBP. …while muscle relaxant use was quite common among patients with acute LBP, the drugs did not help patients return to normal functioning more quickly than patients not taking muscle relaxants, and in fact, were associated with an increase in the time it took for patients to recover from pain.” Return to functional recovery: 16.2 days vs. 32.4 days ( m. relaxants) The Problem! The Dangers of Modern Medicine Medical Mistakes: The 3rd Leading Cause of Death JAMA, July 26, 2000 Vol. 284. No. 4 225,000 deaths/yr = 3rd leading cause of death 3rd only to heart disease and cancer!! Estimates are for death only and do not include adverse effects associated with disability or discomfort. Estimates are low! Epidemiology BMJ March 4, 2000 44,000 to 98,000 unnecessary deaths/yr and 1,000,000 excess injuries. Clinicians inexperienced New procedures introduced Extremes of age, complex care, urgent care, and prolonged hospital stay Medical Errors JAMA, July 26, 2000 Vol. 284. No. 4 44,000 to 98,000 die/yr - Medical errors Of 13 countries, US ranks 12th of 16 indicators (second from the bottom!) WHO ranked US 15th of 25 industrialized countries Medical Errors-Patient Risks “Blunders take 400,000 lives every year, Kaiser head says” (By Robert A. Rosenblatt, LOS ANGELES TIMES Oakland Tribune, July 15, 1999) "Mistakes alone kill more people each year than tobacco, alcohol, firearms or automobiles." "If passengers were asked to fly with a commercial airline organized like most health care, they wouldn’t get on the plane.“ Kaiser is the US’s largest HMO. The 400,000 deaths per year caused by medical mistakes is the largest number I have seen in print so far. JAMA - Hospital Deaths JAMA, July 26, 2000 Vol. 284. No. 4 12,000 deaths/yr - unnecessary surgery 7,000 deaths/yr - medication errors in hospitals 20,000 deaths/yr - other hospital errors 80,000 deaths/yr - nosocomial infections 106,000 deaths/yr - adverse rxn, nonerror 225,000 deaths/yr - iatrogenic causes Let’s Talk About Error BMJ March 2000 While reading this article, 8 injured and one will die. Likelihood of injury at least 3% in hosp. “Reported error rates would go up since we underreport errors and near misses by a factor of 10.” Results of Errors JAMA, July 26, 2000 Vol. 284. No. 4 116 million extra physician visits 77 million extra prescriptions 17 million emergency department visits 8 million hospitalizations 3 million long-term admissions 199,000 additional deaths $77 billion in extra costs Error Underreporting BMJ March 4, 2000 100,000 deaths with many more incurring injuries at an annual cost of $9 billion. “Underreporting of adverse events is estimated to range from 50%-96% annually.” BMJ Statistics BMJ March 2000 100,000 preventable deaths per year in US according to the Institute of Medicine Exceeds the combined deaths and injuries from motor and air crashes, suicides, falls, poisonings, and drownings. Australia produced even higher rates of error. Errors in the Elderly BMJ March 4, 2000 “Preventable adverse events were more common among elderly patients, probably because of the clinical complexity of their care rather than age based discrimination.” Respectfully submitted by: Ronald J. Farabaugh, D.C., CCGPP Committee Member 2879 East Dublin-Granville Rd. Columbus, OH 43231 614-898-0787 email: [email protected] website: www.chirocolumbus.com website: www.chiroltd.com (for information concerning “The Medical Referral System ™” and other products designed to improve your practice.) Copyright Protection Statement The material in this packet is under copyright protection and may not be reproduced in any format without the expressed written consent of Dr. Ronald J. Farabaugh. © Copyright. 2011. All Rights Reserved.