Botulinum toxin A treatment for gastrocnemius tightness and chronic plantar fasciitis
Botulinum Toxin Injection As Treatment for Proximal Medial Gastrocnemius Muscle Tightness with Subsequent Chronic Plantar Fasciitis - a Prospective Clinical Cohort Study
This study is testing if botulinum toxin A injections can help people with tight calf muscles and chronic plantar fasciitis feel better compared to standard surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo, Oslo) |
| Trial ID | NCT05218785 on ClinicalTrials.gov |
What this trial studies
This prospective clinical cohort study will follow 40 patients receiving botulinum toxin A injections for proximal medial gastrocnemius tightness, which is linked to chronic plantar fasciitis. Participants will receive three injections of 75IU at three-month intervals and will be monitored over two years using Patient Related Outcome Measures (PROMS) and physical tests. The study aims to evaluate the effectiveness of this treatment approach compared to traditional surgical methods. The main outcome measure will be the Manchester Oxford Foot Questionnaire (MOxFQ).
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with isolated gastrocnemius contracture and chronic plantar fasciitis who have not responded to at least three months of physical therapy.
Not a fit: Patients who have previously undergone surgery for plantar fasciitis or have severe foot and ankle malalignment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for patients suffering from chronic plantar fasciitis linked to gastrocnemius tightness.
How similar studies have performed: While traditional surgical methods have been well-studied, the use of botulinum toxin A for this specific condition is relatively novel and has shown promising results in preliminary studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oslo, Oslo
- Oslo University Hospital, Orthopedic Department Ullevål — Oslo, Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Elisabet Ellingsen Husebye, MD PhD
- Email: uxngng@ous-hf.no
- Phone: +47 91 50 27 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.