- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02679521
Radial Extracorporeal Shock Wave Treatment for Chronic Plantar Fasciopathy (RSWT_CPF)
The Effectiveness of Extracorporeal Shock Wave Therapy for Patients With Plantar Fasciitis Who Satisfy a Clinical Prediction Rule
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 session. The authors found a statistically significant (p < 0.05) difference in the reduction of the mean Visual Analog Scale composite score between the patients treated with rESWT and the placebo-treated patients both at twelve weeks and twelve months from baseline.
To further evaluate the potential of rESWT to become a routine therapeutic modality in the treatment of chronic plantar fasciitis, the investigators of the present study identified the following questions not addressed in the study by Gerdesmeyer et al. (2008). First, it is unknown whether treatment success can also be reached by two rESWT sessions one week apart, rather than by three rESWT sessions each two weeks apart as applied by Gerdesmeyer et al. (2008). Anecdotal reports by colleagues in Europe indicated that this could indeed be the case. Second, immediate return to normal daily life activities (including sports activities) and normal daily shoe wear indicates that patients suffering from chronic plantar fasciitis and treated with rESWT experience profound pain relief already much earlier than three months after the first rESWT session, applied as first followup in the study by Gerdesmeyer et al. (2008).
Therefore the hypothesis was tested in the present prospective, randomized, double-blinded, placebo-controlled study that treatment of chronic plantar fasciopathy with two rESWT sessions one week apart will result in profound pain relief compared to placebo treatment already four weeks after the first rESWT treatment, lasting for at least six months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults over the age of 18 years
- Diagnosis of painful heel syndrome by clinical examination, with the following positive clinical signs: (i) pain in the morning or after sitting a long time; (ii) local pain where the fascia attaches to the heel; and (iii) increasing pain with extended walking or standing for more than 15 minutes
- History of six months of unsuccessful conservative treatment
- Therapy free period of at least four weeks before referral
- Signed informed consent
Exclusion Criteria:
- Bilateral plantar fasciitis
- Dysfunction of foot or ankle (for example, instability)
- Arthrosis or arthritis of the foot
- Infections or tumors of the lower extremity
- Neurological abnormalities, nerve entrapment (for example, tarsal tunnel syndrome)
- Vascular abnormality (for example, severe varicosities, chronic ischemia)
- Operative treatments of the heel spur
- Hemorrhagic disorders and anticoagulant therapy
- Pregnancy
- Diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: rESWT
Radial extracorporeal shock wave therapy (rESWT).
|
Radial extracorporeal shock wave therapy (rESWT) was performed by the principal investigator with a Swiss DolorClast device (EMS Electro Medical Systems Corporation; Dallas, Texas, USA). The Swiss DolorClast device obtained Pre-Market Approval (PMA) by FDA as Class III orthopedic lithotripsy device to treat heel pain associated with chronic proximal plantar fasciitis on May 8, 2007 (PMA # P050004), and was re-classified as Class III Generator, Shock Wave, For Pain Relief (Product Code NBN) in the Spring 2009. The present study started on October 3, 2007. Each patient received two sessions of rESWT one week apart, with 2,000 impulses per session (air pressure of the device set at 3.5 bar; impulses applied with the 15 mm applicator at frequency of 8 Hz).
Other Names:
|
Placebo Comparator: Placebo
Placebo treatment.
|
Placebo treatment was performed identically as rESWT but with a clasp on the heel that prevented transmission of the impulses from the applicator to the skin at the treatment site.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain (VAS score)
Time Frame: Change from Baseline Pain Score (VAS) at 6 months.
|
Change from Baseline Pain Score (VAS) at 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life (modified Roles & Maudsley score)
Time Frame: Change from Baseline Quality of Life Score (R&M) at 6 months.
|
Change from Baseline Quality of Life Score (R&M) at 6 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mahmoud I Ibrahim, PhD, PT, Rocky Mountain University of Health Professions, Provo, UT 84601, USA
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 070609-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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