Status:
RECRUITING
Treatment of Gastrocnemius Tightness and Subsequent Chronic Plantar Fasciitis with Botulinum Toxin a
Lead Sponsor:
Oslo University Hospital
Conditions:
Plantar Fascitis
Gastrocnemius Tightness
Eligibility:
All Genders
18-75 years
Brief Summary
This prospective clinical cohort study will follow 40 patients who recieve botulinum toxin A treatment for proximal medial gastrocnemius tightness with subsequent Chronic Plantar Fasciitis for two yea...
Detailed Description
The connection between gastrocnemius tightness and plantar fasciitis has been demonstrated in several clinical studies. Patients with chronic pathology, and unsatisfactory results from physical therap...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 18-75 years.
- An isolated gastrocnemius contracture must be verified with the Silfverskiölds test before inclusion.
- Diagnosis plantar fasciitis verified clinically by an orthopaedic surgeon.
- Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological signal changes in the plantar fascia (35)
- Duration of symptoms must be at least 12 months prior to first BTA injection.
- Conventional Physical Therapy must have been tried at least three months without a significant reduction of symptoms in the affected foot.
- Exclusion criteria:
- Previously undergone surgery for plantar fasciitis.
- Patients with severe talocrural pathology or serious malalignment of foot and ankle
- Severely reduced peripheral circulation
- History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
- Patients with a contraindication/non-compliance for MRI examination.
- History of allergic reaction/anaphylactic reaction or other contraindication to botulinum toxin.
- Not able to read and/or speak a Scandinavian language or English adequately.
Exclusion
Key Trial Info
Start Date :
January 13 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05218785
Start Date
January 13 2022
End Date
January 1 2026
Last Update
March 30 2025
Active Locations (1)
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1
Oslo University Hospital, Orthopedic Department Ullevål
Oslo, Oslo County, Norway