Back to resultsGastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis
Primary Purpose
Plantar Fasciitis
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
surgical proximal medial gastrocnemius recession
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fasciitis focused on measuring plantar fasciitis, gastrocnemius recession
Eligibility Criteria
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
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gastrocnemius recession
Arm Description
gastrocnemius recession
Outcomes
Primary Outcome Measures
Change in American Orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score
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 Outcome Measures
0-10 points Visual analog pain score
Difference in pain between groups will be reported on 0-10 points visual analog scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02116478
Brief Title
Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis
Official Title
Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
plantar fasciitis, gastrocnemius recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gastrocnemius recession
Arm Type
Experimental
Arm Description
gastrocnemius recession
Intervention Type
Procedure
Intervention Name(s)
surgical proximal medial gastrocnemius recession
Intervention Description
proximal medial gastrocnemius recession
Primary Outcome Measure Information:
Title
Change in American Orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score
Description
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.
Time Frame
1 year and 6 years postoperative
Secondary Outcome Measure Information:
Title
0-10 points Visual analog pain score
Description
Difference in pain between groups will be reported on 0-10 points visual analog scale
Time Frame
1 year and 6 years postoperative
Other Pre-specified Outcome Measures:
Title
Short form-36 (SF-36)
Description
Difference in subgroup parameters between baseline and follow-up as well as between group differences will be reported
Time Frame
1 year and 6 years postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Molund, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis
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