NCT02116478UnknownNot Applicable
Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis. A Randomized Controlled Trial.
Oslo University Hospital2 sites in 1 country40 target enrollmentStarted: August 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change in American Orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score
Study Overview
Brief Summary
The purpose of the study is to compare the clinical results for patients suffering from plantar fasciitis treated with gastrocnemius recession vs. conservative treatment.
Detailed Description
All patients will be instructed in stretching exercises. Half of the patients will be randomized to proximal medial gastrocnemius recession. All patients will be followed for 1 year. Additional long term follow-up will be 6 years after inclusion
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptoms of plantar fasciitis lasting more than 12 months.
- •Isolated gastrocnemius contracture
Exclusion Criteria
- •No previous surgery to foot or ankle
- •No active arthritis
Outcomes
Primary Outcomes
Change in American Orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score
Time Frame: 1 year and 6 years postoperative
The change in AOFAS from baseline to follow-up, as well as the difference between the groups treated non-operatively and operatively will be reported on a 0-100 scale.
Secondary Outcomes
- 0-10 points Visual analog pain score(1 year and 6 years postoperative)
Investigators
Marius Molund
MD
Oslo University Hospital
Study Sites (2)
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