Treatment of Gastrocnemius Tightness and Subsequent Chronic Plantar Fasciitis with Botulinum Toxin a

Launched by OSLO UNIVERSITY HOSPITAL · Jan 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of botulinum toxin A (often known as Botox) to treat gastrocnemius tightness, which can lead to a painful foot condition called chronic plantar fasciitis. The trial will involve 40 patients aged between 18 and 75 years who have experienced these problems for at least a year and have not found relief from traditional physical therapy. To be eligible, participants must have a specific type of muscle tightness confirmed by a test and a diagnosis of plantar fasciitis verified through an MRI scan.

Participants in the study will receive three injections of botulinum toxin over two years, with each injection spaced three months apart. Throughout the study, they will be monitored at various points to assess their pain levels and physical function through questionnaires and tests. This trial is currently recruiting, and it's important for potential participants to know that they must not have had surgery for plantar fasciitis or any serious foot problems. If you or someone you know fits the criteria and is seeking alternative treatment options, this study could be a valuable opportunity.

Gender

ALL

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.