Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT02196155

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

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

54

Participants Needed

2

Research Sites

543 weeks

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 the classic and most common type of heel pain. Considering the costs for health care and the temporary disability not only for work, plantar fasciitis results in a substantial (and at least partially unnecessary) burden for the Swiss health care system and national economics. Nonoperative treatment is the mainstay of treating plantar fasciitis. However, so far no treatment has proven to be superior to others, and there is national and international lack of consensus of how to treat plantar fasciitis best. The investigators believe that the BTX-A injection in the gastrocnemius and the soleus muscles is currently the most promising non-operative approach, because it is considered to treat the disease at its origin (temporary weakening of the tight triceps surae muscle) as opposed to simply alleviate the symptoms (e.g. plantar cortisone and other injections, ESWT). However, to date there is no evidence in the literature that compares the new, promising technique of BTX-A injection into the gastroc-soleus complex to a sham (saline) injection and to the gold standard steroid injection at the plantar fascia insertion site. With the intended study, this gap is going to be closed.

CONDITIONS

Official 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
  • Diagnosis of 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...

  • Presence of 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 the peripheral nervous system

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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.

CONTACT

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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