Clinical Trial: Radial Extracorporeal Shock Wave Treatment for Chronic Plantar Fasciopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effectiveness of Extracorporeal Shock Wave Therapy for Patients With Plantar Fasciitis Who Satisfy a Clinical Prediction Rule

Brief Summary: Radial extracorporeal shock wave therapy (rESWT) has been previously demonstrated as an efficient treatment option for heel pain associated with chronic proximal plantar fasciitis when administered in three sessions. The present study tested the hypothesis that heel pain associated with chronic proximal plantar fasciitis can also be treated successfully with rESWT when only two treatment sessions are performed.

Detailed Summary:

Plantar fasciitis, the most common cause of heel pain, accounts for approximately 11-15% of foot symptoms presenting to physicians. In the United States, more than two million individuals are treated for PF on an annual basis. The term Plantar Fasciitis implies an inflammatory condition by the suffix 'itis'. However, various lines of evidence indicate that this disorder is better classified as 'fasciosis' or 'fasciopathy'. Details about etiology, pathogenesis, risk factors, diagnosis and general treatment strategies for plantar fasciitis have been provided in a series of comprehensive reviews recently. Briefly, both athletes and the elderly commonly present to physicians with plantar fasciitis, and the diagnosis of plantar fasciitis is usually based on the patient's history and clinical examination. It has been recommended in the literature to start treatment of plantar fasciitis with conservative treatment modalities, including physical therapy, stretching, inserts/orthotics etc. For patients not responding to conservative treatment for 6 months (between 10% and 20% of all patients) extracorporeal shock wave therapy (ESWT) should be considered. In case a patient does not benefit from ESWT either, surgical intervention should be taken into account.

Several randomized, controlled trials of ESWT with focused shock waves for chronic plantar fasciitis were published, demonstrating favourable results in the range of 50% to 70% after a followup period of three months after treatment. Besides this, a recent study demonstrated safety and efficacy of radial extracorporeal shock wave therapy (rESWT) for chronic plantar fasciitis (Gerdesmeyer et al., Am J Sports Med 2008 Nov;36(11):2100-9). These authors administered rESWT or placebo treatment in three sessions, each two weeks (±4 days) apart and evaluated the treatment outcome at twelve weeks and twelve months after the first
Sponsor: Prof. Dr Mahmoud Ibrahim Ibrahim

Current Primary Outcome: Pain (VAS score) [ Time Frame: Change from Baseline Pain Score (VAS) at 6 months. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Quality of life (modified Roles & Maudsley score) [ Time Frame: Change from Baseline Quality of Life Score (R&M) at 6 months. ]

Original Secondary Outcome: Same as current

Information By: Rocky Mountain University of Health Professions

Dates:
Date Received: February 3, 2016
Date Started: October 2007
Date Completion:
Last Updated: February 7, 2016
Last Verified: February 2016