Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia.
M F Brin, M F Lew, C H Adler...
https://pubmed.ncbi.nlm.nih.gov/10534247Actively Recruiting
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-12-10
54
Participants Needed
2
Research Sites
N/A
Total Duration
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
L
Luzerner Kantonsspital
Collaborating Sponsor
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
Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
F
Fabian Krause, PD Dr.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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M F Brin, M F Lew, C H Adler...
https://pubmed.ncbi.nlm.nih.gov/10534247Katalin Bihari
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