Fasciitis, Plantar Clinical Trial
— RSWT_CPFOfficial title:
The Effectiveness of Extracorporeal Shock Wave Therapy for Patients With Plantar Fasciitis Who Satisfy a Clinical Prediction Rule
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Prof. Dr Mahmoud Ibrahim Ibrahim |
Ibrahim MI, Donatelli RA, Schmitz C, Hellman MA, Buxbaum F. Chronic plantar fasciitis treated with two sessions of radial extracorporeal shock wave therapy. Foot Ankle Int. 2010 May;31(5):391-7. doi: 10.3113/FAI.2010.0391. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain (VAS score) | Change from Baseline Pain Score (VAS) at 6 months. | No | |
Secondary | Quality of life (modified Roles & Maudsley score) | Change from Baseline Quality of Life Score (R&M) at 6 months. | No |
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