Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02196155|
Recruitment Status : Recruiting
First Posted : July 21, 2014
Last Update Posted : October 3, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Plantar Fasciitis||Drug: Botulinum toxin A Drug: cortisone Drug: Saline||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis: a Randomized Controlled Study|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
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.
Drug: Botulinum toxin A
Researchers discovered in the 1950s that injecting overactive muscles with minute quantities of botulinum toxin type-A would result in decreased muscle activity. Botulinum toxin type-A has this effect because it prevents the vesicle where the acetylcholine is stored from binding to the membrane where the neurotransmitter can be released. Botulinum toxin type-A thus blocks the release of acetylcholine by the neuron. This will effectively weaken the muscle for a period of three to four months.
In addition to its cosmetic applications, Botox is currently used in the treatment of spasms and dystonias, by weakening involved muscles, for the 60-70 day effective period of the drug. The main conditions treated with botulinum toxin are: Cervical dystonia (spasmodic torticollis) (a neuromuscular disorder involving the head and neck), Blepharospasm (excessive blinking) etc..
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
- Change from baseline in foot pain [ Time Frame: at 6 weeks, 3, 6 and 12 (24) months ]Measured by VAS FA subjective foot score
- Change from baseline in patient health [ Time Frame: at 6 weeks, 3, 6 and 12 (24) months ]Measured by SF 36
- Change from baseline in pain, disability and activity restriction in foot [ Time Frame: at 6 weeks, 3, 6 and 12 (24) months ]Measured by foot functional index FFI
- General pain [ Time Frame: at 6 weeks, 3, 6 and 12 (24) months ]Measured by VAS pain scale
- Reduction of inflammation [ Time Frame: pre-intervention and at 12 months ]Measured by MRI
- Number of patients with complications [ Time Frame: at 6 weeks, 3, 6 and 12 (24) months ]
- Change from baseline in ankle range of motion [ Time Frame: at 6 weeks, 3, 6 and 12 (24) months ]Measured by goniometer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196155
|Contact: Fabian Krause, PD Dr.||email@example.com|
|Dep, of Orthopaedic Surgery, Inselspital, University of Berne||Recruiting|
|Berne, Switzerland, 3010|
|Contact: Fabian Krause, PD Dr. 0041316322220 firstname.lastname@example.org|
|Principal Investigator: Fabian Krause, PD Dr.|
|Sub-Investigator: Maziar Shafighi, PD Dr.|
|Department of Orthopaedic Surgery, Kantonsspital Lucerne||Recruiting|
|Lucerne, Switzerland, 6000|
|Contact: Lukas Iselin, Dr. 004141 205 4807 email@example.com|
|Principal Investigator: Lukas Iselin, Dr.|
|Principal Investigator:||Fabian Krause, PD Dr.||Dep. of Orthopaedic Surgery, Inselspital, University of Berne, Freiburgstrasse, 3010 Berne, Switzerland|