Fasciitis, Plantar Clinical Trial
Official title:
A Clinical Trial of a Multi-Element Exercise Program for Plantar Fasciopathy in Workers Required to Stand for Prolonged Periods of Time
Verified date | March 2013 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Chronic plantar fasciopathy is a painful condition common in the workplace, particularly for those workers required to stand for long periods of time, and is typically associated with point tenderness at heel and arch of the foot. This clinical trial will investigate the effectiveness of an innovative multi-element exercise program versus the standard of care for plantar fasciopathy. The observation period will be 12-weeks. Outcomes are determined through questionnaire and ultrasound imaging. Workers with long-standing plantar fasciopathy who must stand for prolonged periods of time (i.e. > 6 hours) during their workday will be invited to participate in this study. After ensuring eligibility, each subject will be randomly assigned to either the intervention group who will receive a multi-element exercise program, or the control group who will receive a cortisone injection followed by a stretching program for their calf-muscles (standard of care). The treatment length for both groups will be 12-weeks.
Status | Completed |
Enrollment | 56 |
Est. completion date | April 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Adult workers (men and women) between the ages of 19 and 60 - Workers required to stand for 6 hours or more in their respective workplaces - Diagnosed with plantar fasciopathy (plantar fasciitis). All diagnoses will be made by a physiotherapist based on the presentation of palpable pain at or around the plantar medial heel, in addition to pain during weight-bearing activities and the presence of morning pain. - Only individuals with pain for longer than 12 months will be included. Exclusion Criteria: - A history of surgery to their plantar fascia - Osteoarthritis or other degenerative musculoskeletal disorders affecting the lower extremity - Individuals who have received corticosteroid injections into their affected plantar fascia at any time in the past will be excluded. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in Foot and Ankle Disability Index (FADI) at 6 weeks | Patient-centered health-realted quality of life indicator measuriing disability at the foot and ankle. | 6 weeks | No |
Primary | Change from Baseline in Foot and Ankle Disability Index (FADI) at 12 weeks | Patient-centered health-realted quality of life indicator measuriing disability at the foot and ankle. | 12 weeks | No |
Secondary | Change in Ultrasound-Based Grading of Pathology at 12 weeks | A 3-level ordinal scale assessing a composite of hypoechogenicity and neovascularity will be documented. | 12 weeks | No |
Secondary | Change in Acoustoelastographic Analysis of Plantar Fascia Elasticity at 12 Weeks | A novel method of calculating the mechanical properties of deformation dependent soft-tissue using only ultrasound cine-images. Specific outcomes will include plantar fascial stiffness, strain, and modulus of elasticity. | 12 weeks | No |
Secondary | Change in Visual Analog Scale for Pain at 12 weeks | Participants mark on a 100mm line the amount of pain on average they have experienced over the past 7 days. Items for both pain at work and pain with activities of daily living are included. | 12 weeks | No |
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