NCT05218785

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The connection between gastrocnemius tightness and plantar fasciitis has been demonstrated in several clinical studies. Patients with chronic pathology, and unsatisfactory results from physical therapy, may benefit from gastrocnemius lengthening. This is usually obtained with proximal medial gastrocnemius recession surgery (PMGR), but recent studies and recent experience from our hospital suggest that similar effect may be obtained with ultrasound guided- injections of Botulinum Toxin A injections in the proximal medial gastrocnemius muscle. This study will follow patients with gastrcnemius tightness (demonstrated by the Silferskiolds test) and subsequent chronic (MRI-verified) plantar fasciitits who has not recieved satisfactiory results from at least three months of guided physcial therapy. Participants will recieve three ultrasound guided injections of 75IU of Botulinum Toxin A with three month intervals. They will be followed with clinical controls for two years after the first injection. THe main outcome is the Manchester Oxford Foot Questionnaire (MOxFQ).

Conditions

• Plantar Fascitis
• Gastrocnemius Tightness

Interventions

Type	Name	Description
DRUG	Botox	75 U in medial gastrocbemius head. x 3

Timeline

• Start date: 2022-01-13
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2022-02-01
• Last updated: 2025-03-30

Locations

1 site across 1 country: Norway

Regulatory

• FDA-regulated drug study