Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID02196155

Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis: a Randomized Controlled Study

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-12-10

54

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

I

Insel Gruppe AG, University Hospital Bern

Lead Sponsor

L

Luzerner Kantonsspital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Plantar fasciitis is a common cause of heel pain that leads to significant healthcare costs and work disability, especially in Switzerland. Despite various treatments, no single approach has proven clearly superior, and there is no consensus on the best nonoperative therapy. Researchers are studying whether injecting botulinum toxin A (BTX-A) into the calf muscles can offer better treatment by targeting the muscle tightness that contributes to the condition. In this randomized study, participants are assigned to one of three groups. One group receives BTX-A injections into the gastrocnemius and soleus muscles along with physiotherapy and stretching exercises. The second group gets cortisone injections at the plantar fascia insertion site combined with the same physiotherapy. The third group receives saline injections as a placebo control, also combined with physiotherapy and stretching. Each BTX-A injection involves 100 units into each gastrocnemius muscle belly and 50 units into the soleus, totaling 250 units. Participants will be followed over time to assess changes in foot pain, health, disability, activity restriction, ankle motion, and inflammation. These evaluations occur at 6 weeks, 3 months, 6 months, 12 months, and 24 months. MRI scans will assess inflammation before treatment and at 12 months. The study aims to provide clear evidence comparing BTX-A, cortisone, and placebo injections to help guide future treatment choices. The total duration of participation may last up to two years with regular assessments.

CONDITIONS

Brief Title

Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical symptoms of plantar fasciitis
  • Plantar fasciitis confirmed by MRI
  • Exclusion of other diagnoses
  • Symptoms lasting more than 3 months
  • At least 3 months of unsuccessful treatment
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • Active other diagnoses
  • Pregnancy or breastfeeding
  • Infection at injection sites
  • Allergy to botulinum toxin A
  • Previous injections or surgery for plantar fasciitis
  • Neurological diseases affecting peripheral nerves

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session with follow-up assessments over 12 to 24 months

Participants receive injections of Botulinum toxin A, cortisone, or saline, alongside physiotherapy and stretching exercises.

1 treatment visit and multiple follow-up visits over 24 months

Follow-up

Duration - Up to 24 months

Participants are monitored for changes in foot pain, health status, inflammation, and ankle range of motion after treatment.

Follow-up visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months

Trial Site Locations

Total: 2 locations

1

Dep, of Orthopaedic Surgery, Inselspital, University of Berne

Bern, Switzerland, 3010

Actively Recruiting

2

Department of Orthopaedic Surgery, Kantonsspital Lucerne

Lucerne, Switzerland, 6000

Actively Recruiting

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Research Team

F

Fabian Krause, PD Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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Published Research Related To This Trial

Safety, effectiveness, and duration of effect of BOTOX after switching from Dysport for blepharospasm, cervical dystonia, and hemifacial spasm dystonia, and hemifacial spasm.

Katalin Bihari

https://pubmed.ncbi.nlm.nih.gov/15811212

A comparison of botulinum toxin a and intralesional steroids for the treatment of plantar fasciitis: a randomized, double-blinded study.

Jorge Elizondo-Rodriguez, Yariel Araujo-Lopez, J Alberto Moreno-Gonzalez...

https://pubmed.ncbi.nlm.nih.gov/23386757