Botulinum toxin A treatment for gastrocnemius tightness and chronic plantar fasciitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.