Download Heel Pain Syndrome - Laurel Foot and Ankle Center

Use of Extracorporeal Shock Wave
Treatment (ECSWTT) for Orthopedic
Indications
Orthospec
The Orthospec orthopedic
shock wave device provides a
non-surgical, non-invasive
alternative for patients
suffering from pathological
bone and joint conditions,
calcification and diseases of
the tendon. This method of
treatment is proving
increasingly popular with
patients and physicians alike.
Over 100,000 cases
worldwide have been treated
with shock wave therapy for
orthopedic ailments.
History and Background
• 1980: first clinical use of ECSWT lithotripsy for renal
calculi (Chaussy et al, 2:1265, 1980)
• 1984: first ECSWT lithotripter for renal calculi approved
by FDA
• 1986: first use of ECSWT treatment for tissue healing in
skin grafts (Haupt and Chavpil, J. Surg. Re., 49:45, 1990)
• 1991: first clinical use of ECSWT treatment for nonunion
fractures (Valchanou and Michailov, Internat. Ortho.
15:181-184, 1991)
Definition and Characterization of
Shock Waves
• A shockwave is a sonic pulse
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High peak pressure(500 bar)
Short Life Cycle (10 ms)
Fast Rise Time (<10 ns)
Broad Frequency spectrum (up to 20MHZ)
Direct Mechanical Force(Primary Effect)
Indirect Mechanical Force (Secondary Effect)
Water Jet Phenomena
Formation of A Shockwave
When an electrical charge is produced
inside of the water-filled ellipsoid; there
are two reactions which occur inside the
treatment head. There is and initial
expansion of the water molecules (direct
effect/positive pressure of the shockwave);
followed by an implosion of the water
molecules (indirect effect/negative
pressure/tensile wave).
How do shockwaves travel?
• The shock waves that are produced in a
water medium reflect off the interior walls
of the ellipsoid and converge at a second
focus, known as F2
• F2 is positioned to be at the treatment
location
ECSWT
• The shockwaves are not hindered by water
or high water content tissues due to the fact
that the acoustic impedance of water and
most soft tissues of the body are similar
• Therefore, shockwave energy passes
through soft tissues relatively unobstructed
without damaging the tissue
Types of Shockwaves
•Electrohydraulic – high energy (.20mj/mm < )
2
Incorporates an electrode submerged in a water-filled housing
composed of an ellipsoid & a patient interface. Shock wave
generated by an electrical spark.
•Electromagnetic – medium energy (~.12mj/mm
2
>
20mj/mm2 )
Uses an electromagnetic coil & an opposing metal membrane.
Electromagnetic forces induce a slow & low acoustic pulse
focused by an acoustic lens.
•Piezoelectric – low energy (> ~.12mj/mm )
2
Form acoustical waves by mounting piezoelectric crystals to a
spherical surface. High voltage pulse is applied & focused by the
geometric shape of the sphere.
Differences in Shockwave Parameters
Electrohydraulic
Electromagnetic
• Highest Positive Pressure and
highest total energy at all power
settings
• Positive pressure is under one half
the strength of electrohydraulic at
same power settings
• Treatment area becomes larger as
power increases
• Treatment area becomes smaller as
power increases
• Because treatment area becomes
larger, the amount of energy
delivered in a mm2 has minimal
variability as energy levels
increase allowing the delivery of
the highest total energy at all
settings in a safer concentration
• Because treatment area narrows as
energy levels increase, the energy
in a mm2 becomes rapidly
concentrated to above therapeutic
levels1.
1Rompe,
JD et al, Dose-related effects of shock waves on rabbit tendo Achillis. A sonographic and histological study. J
Bone Joint Surg BR 1998 May; 80(3):546-52
Biological Effects
• Disruption of cell membranes
• Neovascularization
• Stimulate osteoblasts, chondroblasts,
macrophages
Possible Mechanisms of Healing
Fracture Healing
• Microfracture; disruption of sclerotic bone (Haupt,
Chvapil; 1990)
• Subperiosteal hemorrhage, stimulation of healing
(Delius et al, 1995)
Tendinopathies
• Microhemorrhage; thrombus formation,
stimulation of healing (Drach et al, 1992)
Inclusion Criteria: Chronic Heel
Pain Syndrome Study
• Pain over origin of plantar fascia on medical
calcaneal tuberosity
• Minimum 6 months duration of symptoms
• Failure to respond to 3 prior courses of
noninvasive treatment (e.g., NSAID’s,
orthotic device, PT/stretching exercises)
• Potential surgical candidate
Exclusion Criteria: Chronic Heel
Pain Syndrome
• Rule out vascular insufficiency or
complicating neuropathy
• Rule out fracture, osteo- or rheumatoid
arthritis, malignancy
Primary Evaluation Parameters:
Chronic Heel Pain Syndrome Study
• Investigator’s assessment of point
tenderness, affected heel (10cm VAS)
• Subject’s assessment of pain, affected heel
(10cm VAS)
• Subject’s assessment of activity
• Pain medication requirements
Treatment Protocol: Chronic
Heel Pain Syndrome Study
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Localize treatment area
Anesthesia - heel block
1500 shocks at 18 kV
May repeat treatment if failure to respond at
3 months
Success Criteria: Chronic Heel
Pain Syndrome Study
• Physician Assessment/Patient SelfAssessments: Improvement > 50% and
VAS < 5.0
• No pain medications or anti-inflammatory
medications
• No adjunct treatments or interventions
COMPLICATIONS: Heel Pain
Pivotal Study
• Overall complication rate = 4.7%
• Primarily localized bruising at treatment site
• Symptoms were mild and transient in nature
Indications
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Plantar fasciitis
Tennis elbow
Jumpers knee
Calcific tendinits shoulder
Achilles tendinopathy
Stress fractures
Non unions
Avascular necrosis
Peyronies
Indications for Orthotripsy
• Six months or more of symptoms
• Proper diagnosis by treating physician to
rule out other heel pain conditions
• Failure of at least three conservative
treatments
• Patient is a candidate for invasive surgery
Non Operative Treatment
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NSAIDS
U/S
Ice
Rest
Steroids
Orthotics
CONTRAINDICATIONS:
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Pediatric patients with an open physis
Pregnant patients
Significant PVD
Severe osteoporosis
Rheumatoid arthritis
Diabetic neuropathy
Tarsal tunnel syndrome/nerve entrapment
syndromes
ADDITIONAL
CONTRAINDICATIONS:
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Fracture of the calcaneus
Metabolic disorders
Malignancies
Paget’s disease
Osteomyelitis
Systemic infections
Patients with bleeding disorders
Patient Pre-op Instructions:
• Patient must d/c NSAIDs or ASA at least 3
days prior to the procedure.
• Bring running shoes to the surgery center
Treatment Protocol
• Prior to Anesthesia Physician localizes
treatment area - point of maximum pain and
marks area on heel
• Patient receives anesthesia - Type of
anesthesia is at physician’s discretion
• 1500 shocks at 18 kV are administered
Discharge Orders:
• The patient is transported to the recovery
room.
• After recovery from anesthesia patient can
ambulate and weight bear immediately.
• DO NOT allow the patient to take any
NSAIDs post-op for 12-16 weeks.
• The patient may take Tylenol post-op.
Indications for Use
Heel Pain Syndrome
• FDA Approved October 12th, 2000
Chronic Lateral Epicondylitis
• FDA Approved March 18th, 2003