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Evaluation of Balance Acupuncture for Pain Relief in Cancer Patients Briony Hudson School of Psychology, University of Surrey, Guildford, GU2 7XH, [email protected] Dr Leslie Storey School of Psychology, Queen’s University, Belfast, BT7 1NN, [email protected] Charlie Verschoyle The Fountain Centre, St Luke’s Cancer Centre, Guildford, GU2 7XX, [email protected] Robin Burby The Fountain Centre, St Luke’s Cancer Centre, Guildford, GU2 7XX, [email protected] Abstract Aims: To explore the impact of balance acupuncture on pain relief for cancer patients in a multi-bed setting. Methods: 9 patients completed a 6 week course of balance acupuncture focusing on pain relief. The measure yourself concerns and wellbeing form (MYCaW) was completed at baseline, trial midpoint (3 weeks) and completion (6 weeks). Outcomes included ratings of pain, general wellbeing and the impact of another patient identified concern. Current pain, average pain and the intensity of pain were also assessed over the course of the trial, using a pain thermometer. Results: After 3 weeks of twice weekly balance acupuncture, significant reductions were observed in the extent to which pain bothered patients (MYCaW) and the intensity of pain experienced over the previous week. Upon completion of the 6 week course, significant improvements were observed in the average level of pain experienced over the past week and the extent to which patients were bothered by a second concern as listed on the MYCaW form. Conclusions: Balance acupuncture in a multi-bed setting is an effective method of reducing pain in this sample. A larger trial is needed to provide more robust, generalisable results. The authors declare that there are no conflicts of interest regarding the publication of this paper. 1 Introduction The side effects of cancer and its associated treatments are far reaching and well documented (1). Pain is a common side effect and is linked with depression, anxiety and sleep disturbance (2). A recent Cochrane review reported that 45% of people with early or intermediate stage cancer, and 90% of those with advanced stage cancer experience moderate to severe pain. Furthermore, up to 70% of those experiencing cancer pain do not receive adequate pain relief (3). In light of such statistics it is unsurprising that increasing numbers of cancer patients are turning to complementary therapies to help manage their pain and improve their quality of life (1, 4). Acupuncture, an important component of Traditional Chinese Medicine (TCM) has been used for centuries in Eastern cultures to treat conditions ranging from pain to digestive disorders. Despite the widespread use of acupuncture in Eastern society and its growing usage in the West, there is a lack of quality research into its use. The limited literature contains many discrepancies and inconsistent findings regarding acupuncture’s efficacy as a treatment for cancer pain. Indeed, a recent systematic review of 15 randomised clinical trials investigating acupuncture for cancer pain (5), proved inconclusive due to the methodological flaws of the studies reviewed. This paper is not the first to reach this conclusion (6, 7). There is a real need for robust, rigorous research into what could potentially be an extremely useful tool for reducing pain and improving the quality of life for 77% of the UK’s cancer patients. TCM takes a holistic approach to the treatment of pain and illness and operates on the principle that energy, known as qi, flows through meridians in the body. The theory states that blockages in these meridians prevent the flow of qi, resulting in pain or illness. The insertion of very fine needles is thought to remove these blockages and allow qi to flow freely once more, restoring the body to health and relieving pain. The Balance Method of acupuncture taught by Dr Richard Teh Fu Tan states that each meridian has several paired channels in different anatomical sites meaning that needles need never be applied to painful areas. Patients often report very rapid results and are not required to disrobe as needles are only applied to the lower arms, legs, hands, feet and head, making balance acupuncture the perfect option for use in a multibed setting. This study aims to provide a pilot for a larger scale multi-bed trial of a 6 week course of balance acupuncture for cancer patients and their carers. Materials and Methods Setting and study population Data collection took place at The Fountain Centre, a charity providing support and complementary therapies to cancer patients in the St Luke’s Cancer Centre at the Royal Surrey County Hospital in Guildford. Data was collected as part of an internal audit and as such ethical review was not required. Patients were recruited through posters around St Luke’s Cancer Centre and through referrals from within the hospital. Thirteen patients experiencing pain were originally recruited to the study. Three were excluded as they attended less than 3 treatment sessions, meaning follow up data was unavailable. One 2 patient was unable to attend due to a deterioration in health (unrelated to the trial) while 2 decided not to continue with the trial after the first session. All outcome measures were collected for 9 cancer patients. The sample had a mean age of 65.4 years, ranging from 55 to 80 and was composed of 5 females and 4 males. Measures Measure Yourself Concerns and Wellbeing (MYCaW) The MYCaW (8) was specifically designed for use with complementary therapy cancer patients to measure change in two patient identified concerns over time. This measure was developed in recognition of the specific challenges associated with assessing holistic care. Patients identify, in their own words “one or two concerns or problems” that they would like to address through the intervention. For all patients in this sample, concern number 1 was pain (the location of this pain is listed in table 1). These concerns are then rated on a 7 point scale, from 0 (not bothering me at all) to 6 (bothering me greatly). In addition patients rated their current general feeling of wellbeing on a 7 point scale from 0 (as good as it could be) to 6 (as bad as it could be). The MYCaW follow up form asks patients to repeat the ratings of concern 1 (pain), concern 2 and general wellbeing. Two additional, optional questions “other things affecting your health” and “what has been most important to you” are also included on the form. The follow up form was completed at week 3 and week 6 and participants’’ responses are outlined in figure 3. Pain Thermometer The pain thermometer is a simple and effective visual tool for assessing pain (9). It contains a faces rating scale of 0, no pain to 10, extreme pain, mapped onto the picture of a thermometer. Patients indicated which point, or face, corresponds with their current level of pain, their average pain over the last week and the worst pain experienced over the last week (pain intensity). Methods Consenting patients completed the MYCaW and pain thermometer at the clinic before their first session of acupuncture. The balance acupuncture was delivered in a multi-bed setting, meaning four patients could be treated simultaneously, by two qualified acupuncturists. The number of sessions attended by participants ranged from 3 to 11, with participants attending on average 7.6 sessions. Patients were not required to disrobe and the specific sites for needles were located by palpating for tender areas along meridians corresponding to those running through the affected area. The location and frequency of needles applied was recorded. Once the needles were in place, the acupuncturist sanitised their hands before applying fresh needles to the next patient. After thirty minutes the needles were removed from the first patient. Acupuncture was administered on a rolling basis with patients arriving at twenty minute intervals. During the first 3 weeks of the course, patients attended twice weekly. During week 3 patients completed the 3 MYCaW follow up form and repeated the pain thermometer measures. Patients were then advised how often they should attend for the duration of the course, once or twice weekly. This decision was based upon the progress made in terms of pain reduction. The MYCaW and pain thermometer were repeated for a final time at week 6. Three patients were unable to attend the final session and their follow up data was collected via telephone. Data analysis The data was analysed using SPSS version 20. General wellbeing scores were reversed so that higher scores indicated an improvement. The demographic characteristics and MYCaW concerns are displayed in table 1. In light of the small sample size (n=9) and in the absence of normality, non-parametric statistical tests were chosen. Friedman tests assessed whether ratings were statistically different across the three time points (baseline, week 3 and week 6) for all quantative outcomes. Significant Friedman’s tests were followed up with Wilcoxon signed rank tests (conducted with a Bonferonni correction resulting in a significance level of p<.017) to identify the location of significant differences. Qualitative MYCaW data was analysed in line with a published framework (10) and are reported in figure 3. Results Table 1. Demographic and baseline patient characteristics N % Age Sex Male Female Ethnicity White Primary Cancer Type Colon Breast Skin Oesophageal Prostate MYCAW pain rating Pain location Back Localised post-surgical pain Feet Legs Hips Neck MYCAW concern 2 Physical concerns Psychological/emotional concerns Hospital(treatment) concerns) Wellbeing concerns Number of sessions attended 4 4 5 45.5 55.5 9 100 2 3 1 1 2 22.2 33.3 11.1 11,1 22.2 2 2 1 2 1 1 22.2 22.2 11.1 22.2 11.1 11.1 5 2 1 1 55.5 22.2 11.1 11.1 Mean SD Range 65.4 8.9 25 (55-80) 7.67 2.5 6 (4-10) 4.3 1.5 4 (2-6) 7.6 2.6 8 (3-11) Table 2. MYCaW and pain thermometer ratings at baseline, at the midpoint of the trial (week 3) and upon trial completion (week 6). Baseline MYCaW pain MYCaW concern 2 MYCaW General Wellbeing Current pain Average pain Week 3 Base line to Week 6 (p) Week 3 to week 6 (p) -2.38* -2.37* -1.67 -1.98 -2.40* 4 (0-4) -1.00 -1.52 -.70 1.0 (1.1) 3 (0-3) -1.45 -1.57 -1.0 7 (1-8) 1.6 (1.5) 5 (0-5) -1.8 -2.31* -2.0* 9 (1-10) 4.1 (3.2) 9 (1-10) -2.38* -1.0 Mean (SD) Range Mean (SD) Range Mean (SD) Range 4.7 (1.3) 4.3 (1.5) 3 (3-6) 4 (2-6) 2.1 (1.6) 3.3 (1.5) 5 (1-6) 5 (1-6) 1.6 (1.9) 3.0 (1.9) 6 (0-6) 6 (0-6) 2 3.4 (1.1) 4 (2-6) 3.7 (1.3) 4 (0-4) 3.9 (1.4) 1.45 2 2.6 (3.4) 10 (0-10) 1.2 (1.3) 4 (0-4) 7.4* 2 4.1 (2.8) 8 (0-8) 2.4 (2.3) 2 7.7 (2.5) 6 (4-10) 4.6 (3.7) (p) Df 13.86** 2 9.36** 2 1.83 11.6** Worst pain Wilcoxon signed rank test compared to baseline (p value) Week 6 Base line to Week 3 (p) -2.37* Friedman’s tests: ***p<.001, ** p<.01, * p<.05, Wilcoxon signed rank tests:***P<.0003, **P<.003, * P<.017 (bonferonni corrections) 10 9 8 7 6 5 4 3 2 1 0 6 5 4 3 2 1 Current Pain Average Pain Worst Pain MYCaW Pain Week 6 Week 3 Baseline Week 6 Week 3 Baseline Week 6 Week 3 Baseline Week 6 Week 3 Baseline Week 6 Week 3 Baseline Week 6 Week 3 Baseline 0 MYCaW Concern 2 MYCaW General Wellbeing Figure 1. Bar chart to show the changes in mean Figure 2. Bar chart to show the changes in mean scores for MYCaW outcomes at baseline, week 3 current, average and worst pain scores at baseline and week 6 week 3 and week 6 MYCaW outcomes Mean pain ratings, as measured on the MYCaW significantly reduced from baseline by week 3, ( (2) = 13.86, p=.001, z=-2.38, p=.016) with a mean difference of 2.6 points on a 7 point scale. At 6 weeks, mean 5 -1.13 reduction from baseline had reached 3.1 points (z=-2.37, p=.016). Mean ratings for the extent to which patients were bothered by concern 2 were also significantly reduced by completion of the acupuncture course ( (2) = 9.360, p=.009, z=-2.401, p=.016). No significant differences were observed in ratings of general wellbeing ( (2) =1.826, p=.401). Pain thermometer outcomes Mean pain intensity (worst pain) over the last week was significantly reduced by week 3 ( (2) = 11.6, p=.003, z=-2.37, p=.016) and remained significant at week 6, (z=-2.37, p=.016). Average pain intensity over the last week was significantly higher at baseline than week 6 ( current pain were not significantly reduced by week 6 ( (2) = 7.40, p=.025). Ratings of (2) =1.45, p=.483). Qualitative outcomes Figure 3 contains the qualitative data collected on MYCaW follow up. Factors identified as the most important aspects of the acupuncture sessions included, pain relief, relaxation, support and improvements in wellbeing. Not all patients chose to complete this section. What has been most important for you? Week 3 Relaxing for 20-30 minutes Helping to relax Week 6 Overall feel that the trial has helped. Glad I did it and have enjoyed relaxing. Relief from pain. Improved psychological outlook from support and attention and care. This is the missing element -others too busy. Overall sense of well being. Feeling of support from a team working towards improving my condition. This helps psychologically and makes you work harder yourself. It stops you giving up. Feels like a positive thing to help improve the condition. Desperately wanted it to help and it has helped but not as positively as I had hoped. But if I had not had positive feelings towards the trial I would not have come religiously twice a week. Relief in shoulder and neck pain that he has had for 7 years. Greater range of movement, is still limited but less painful. The pain and shoulder stiffness leaving. Enjoyed the relaxation, it was not painful and it worked! The complete loss of pain to arm/breast. Total feeling of wellbeing Felt very welcome, felt very good when leaving. Something is being done and is starting to have an effect The whole experience. Environment, experienced therapists and explanations. Felt very in control. Huge benefit, would suggest it. Relief from pain and self management through applying pressure to pressure points. Have reduced Removal of intermittent severe pain cocodamol intake, now taking 2 tablets a day instead of 6-8 Figure 3. Patients’ responses to the question “what has been most important for you, on the MYCaW follow up forms at week 3 and week 6 6 SUMMARY OF RESULTS Statistically significant reductions from baseline at week 3 Statistically significant reductions from baseline at week 6 Outcomes that did not reach statistical significance Extent to which patients were bothered by pain Pain intensity in last week Extent to which patients were bothered by pain Extent to which patients were bothered by MYCaW concern 2 Average pain over the last week Pain intensity in last week Current pain General wellbeing (MYCaW) Discussion Within the first 3 weeks of the course of acupuncture, significant reductions were reported in the extent to which patients were bothered by their pain and also the worst pain intensity they experienced over the past week. In addition, at 6 weeks, significant improvements were observed in average pain experienced over the past week and the extent to which patients were bothered by their second MYCaW concern. The size and speed of the improvements observed are encouraging. While improvements were evident in all outcome measures studied, improvements in current pain and general wellbeing did not reach significance. A potential explanation for this could be the characteristics of the pain under focus. A number of patients presented with pain that was not constant but was initiated or exacerbated by particular movements or activities. For example, one patient presented with chest pain that was very intense when walking uphill; but largely absent when stationary or when walking on level ground. As measures of current pain were taken when the patient was seated, in isolation they would imply that acupuncture had not been particularly beneficial. However the patient reported dramatic reductions in average pain and intensity when walking up hill after 2 sessions of acupuncture. Three weeks into the course of acupuncture, the patient went on a hilly walking holiday, which would previously have been impossible. The inclusion of measures of average pain and worst pain intensity meant that the inadequacies of a single pain measure were addressed and a reflection of full pain experience obtained. While general wellbeing scores improved; this improvement did not reach significance. When taking the qualitative data into account, this seems surprising. Many patients used words such as “relief”, “relaxation”, “support” and “benefit” to describe the most important aspects of the acupuncture, all of which suggest acupuncture was a useful, positive experience. The inconsistencies between the qualitative and quantitative data emphasise the importance of considering mixed methods when investigating subjective topics such as pain, particularly in the context of an illness like cancer. In this evaluation, balance acupuncture was conducted in a multi-bed setting. This increased efficiency but also provided a safe environment for patients to talk to others experiencing similar illnesses. The majority of patients reported enjoying this and used the opportunity to talk with other patients in an informal and relaxed environment, sometimes about their illness and sometimes just shared interests. This set up fostered a sense of community and a collaborative relationship between patients and acupuncturists with both 7 working with and listening to the other. The benefits of this type of relaxed and also empowering approach were highlighted in the comments given by one patient in the most import aspect section of the MYCaW: “Feeling of support from a team working towards improving my condition. This helps psychologically and makes you work harder yourself. It stops you giving up. Feels like a positive thing to help improve the condition.” One patient reported a dislike for the multi-bed setting, and felt it was “not hygienic” despite the acupuncturists’ use of hand sanitizer between each patient and new sterile needles for each. Overall however the multi-bed set up was very well received and would be a viable option for a larger scale study. Despite the promising results observed there are obvious limitations to this evaluation, most importantly the relatively low number of patients involved and lack of control condition. This evaluation aimed to assess the viability of a larger trial with the same goals, in the same setting. Given the positive results obtained, this evaluation indicates further, rigorous research is vital, feasible and appropriate for this centre. A robust randomised controlled trial containing both a control and sham acupuncture group would be ideal. Given the well documented methodological limitations of previous research in this area, it is imperative that any further trials meet all guidelines for a robust and scientifically rigorous study, in order to provide gold standard evidence for the use of acupuncture for pain relief for this patient group. The lack of control condition makes it difficult to distinguish between the effects of the acupuncture, the regular contact with the team, dedicated time for relaxation and possible placebo effects. However, the benefits gained by patients over a short period suggest that further investigation into the effects of acupuncture in this population is justified. To conclude, a 6 week course of balance acupuncture led to significant reductions in the intensity and average rating of pain experienced by patients over the previous week and the degree to which patients were bothered by their pain and another identified concern. This is an important finding given the current lack of acceptable alternatives to pharmaceutical approaches for cancer patients. Further research, on a larger scale, including a health economics assessment, is warranted to fully explore the role that acupuncture could play in pain management for cancer patients – both those currently receiving treatment and those who are dealing with ongoing post-surgical pain. Acknowledgements Special thanks go to the staff and volunteers of The Fountain Centre 8 References 1. Lengacher, C. A., Bennett, M.P., Kip, K.E., Gonzales, L., Jacobsen, P., & Cox, C.E. (2006). 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