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

NCT05218785 | Recruiting FDA Drug

• 1 other identifier: REK351430
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Plantar Fascitis; Gastrocnemius Tightness

Keywords

proximal medial gastrocnemius recession; gastrocnemius tightness; botox; botulinum toxin a

Outcome Measures

Primary Outcomes (1)

• Manchester Oxford Foot Questionnaire

  MOxFQ (Manchester Oxford Foot Questionnaire) is a PROM consisting of 16 questions in three domains (pain, walking/standing, social interaction) leading to a total score from 0-100, 0 being the best possible score. It is validated as a reliable tool to measure results of foot and ankle surgery

  2 years

Secondary Outcomes (6)

• Achilles function test battery

  2 years

• Ankle dorsiflexion

  2 years

• Visual Analogue Scale (VAS)

  2 years

• EQ5D5L

  2 years

• AOFAS (American Orthopeadic Foot and Ancle Society) hindfoot score

  2 years

Study Arms (1)

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.

Drug: Botox

Interventions

Botox DRUG

75 U in medial gastrocbemius head. x 3

Botulinum toxin A injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population consists of patients who recieve routine care at our hospital.

You may qualify if:

• Age 18-75 years.
• 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.

You may not qualify if:

• Previously undergone surgery for plantar fasciitis.
• Patients with severe talocrural pathology or serious malalignment of foot and ankle
• Severely reduced peripheral circulation
• History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
• Patients with a contraindication/non-compliance for MRI examination.
• History of allergic reaction/anaphylactic reaction or other contraindication to botulinum toxin.
• Not able to read and/or speak a Scandinavian language or English adequately.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Orthopedic Department Ullevål

Oslo, Oslo County, Norway

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Elisabet Ellingsen Husebye, MD PhD

CONTACT

+47 91 50 27 70; uxngng@ous-hf.no

Martin Riiser, MD Phd candidate

CONTACT

+47 91 50 27 70; mriise@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: January 13, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)