Botulinum Toxin Injection As Treatment for Proximal Medial Gastrocnemius Muscle Tightness with Subsequent Chronic Plantar Fasciitis - a Prospective Clinical Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Age 18-75 years.

• An isolated gastrocnemius contracture must be verified with the Silfverskiölds test before inclusion.

• Diagnosis plantar fasciitis verified clinically by an orthopaedic surgeon.

• Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological signal changes in the plantar fascia (35)

• Duration of symptoms must be at least 12 months prior to first BTA injection.

• Conventional Physical Therapy must have been tried at least three months without a significant reduction of symptoms in the affected foot.

Locations
Other Locations
Norway
Oslo University Hospital, Orthopedic Department Ullevål
RECRUITING
Oslo
Contact Information
Primary
Elisabet Ellingsen Husebye, MD PhD
uxngng@ous-hf.no
+47 91 50 27 70
Backup
Martin Riiser, MD Phd candidate
mriise@ous-hf.no
+47 91 50 27 70
Time Frame
Start Date: 2022-01-13
Estimated Completion Date: 2026-01
Participants
Target number of participants: 40
Treatments
Botulinum toxin A injection
Patients will receive a total of 3 -three - injections of 75 IU Botulinum Toxin A in the proximal medial gastrocnemius muscle. Treatments will be performed by a specialist in neurology as a Ultra-Sound guided injection into the proximal medial gastrocnemius muscle Injections will be administered at baseline, 3 months and 6 months.
Related Therapeutic Areas
Sponsors
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov