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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Clinical symptoms of a plantar fasciitis

• Plantar fasciitis in MRI

• Exclusion of differential diagnoses

• Symptoms more than 3 months

• Absolution of 3 months unsuccessful treatment

• Written informed consent

Locations
Other Locations
Switzerland
Dep, of Orthopaedic Surgery, Inselspital, University of Berne
RECRUITING
Berne
Department of Orthopaedic Surgery, Kantonsspital Lucerne
RECRUITING
Lucerne
Contact Information
Primary
Fabian Krause, PD Dr.
fabian.krause@insel.ch
0041316322220
Time Frame
Start Date: 2016-07
Estimated Completion Date: 2026-12
Participants
Target number of participants: 54
Treatments
Active_comparator: BTX-A
Botulinum A toxin is injected each 100 U in both gastrocnemius muscle-bellies and 50 U in the soleus muscle, i.e. a total of 250 U.
Active_comparator: Cortisone
Depot Medrol is injected at the plantar fascia insertion site at the calcaneus
Placebo_comparator: Saline
Placebo saline is injected in both gastrocnemius muscle-bellies and in the soleus muscle
Sponsors
Collaborators: Luzerner Kantonsspital
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov