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 – – – – – – –

High peak pressure(500 bar) Short Life Cycle (10 ms) Fast Rise Time (

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 • • • •

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 • • • • • • • • •

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 • • • • • •

NSAIDS U/S Ice Rest Steroids Orthotics

CONTRAINDICATIONS: • • • • • • •

Pediatric patients with an open physis Pregnant patients Significant PVD Severe osteoporosis Rheumatoid arthritis Diabetic neuropathy Tarsal tunnel syndrome/nerve entrapment syndromes

ADDITIONAL CONTRAINDICATIONS: • • • • • • •

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