NCT05218785 Treatment of Gastrocnemius Tightness and Subsequent Chronic Plantar Fasciitis with Botulinum Toxin a
| NCT ID | NCT05218785 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Plantar Fascitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-01-13 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2022-01-13 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05218785 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Plantar Fascitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05218785 currently recruiting?
Yes, NCT05218785 is actively recruiting participants. Contact the research team at uxngng@ous-hf.no for enrollment information.
Where is the NCT05218785 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT05218785 clinical trial?
NCT05218785 is sponsored by Oslo University Hospital. The trial plans to enroll 40 participants.