Botulinum Toxin Injection as Treatment for Proximal Medial Gastrocnemius Muscle Tightness With Subsequent Chronic Plantar Fasciitis - A Prospective Clinical Cohort Study

REK351430

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 years. Three injections of botulinum toxin (75IU) will be administered with intervals of three months. Participants will be followed at baseline, 3 months, 6 months, 1 year and 2 years with Patient Related Outcome Measures (PROMS) and physical test (Ergotest and ankle dorsiflexion).

2022-01-13

2026-01-01

2026-01-01

Recruiting

40

Inclusion criteria: 1. Age 18-75 years. 2. An isolated gastrocnemius contracture must be verified with the Silfverskiölds test before inclusion. 3. Diagnosis plantar fasciitis verified clinically by an orthopaedic surgeon. 4. Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological signal changes in the plantar fascia (35) 5. Duration of symptoms must be at least 12 months prior to first BTA injection. 6. Conventional Physical Therapy must have been tried at least three months without a significant reduction of symptoms in the affected foot. Exclusion criteria: 1. Previously undergone surgery for plantar fasciitis. 2. Patients with severe talocrural pathology or serious malalignment of foot and ankle 3. Severely reduced peripheral circulation 4. History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent. 5. Patients with a contraindication/non-compliance for MRI examination. 6. History of allergic reaction/anaphylactic reaction or other contraindication to botulinum toxin. 7. Not able to read and/or speak a Scandinavian language or English adequately.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-03-22