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.
Clinical symptoms of a plantar fasciitis
Plantar fasciitis in MRI
Exclusion of differential diagnoses
Symptoms more than 3 months
Active differential diagnoses
Contraindications: pregnancy and breastfeeding, infection at injection sites, allergy against BTX-A
Previous injections or surgery for plantar fasciitis
Neurological diseases affecting the peripheral nervous system
Parallel
Botulinum toxin A
DrugResearchers 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..
cortisone
DrugSaline
DrugChange from baseline in foot pain
Measured by VAS FA subjective foot score
Change from baseline in patient health
Measured by SF 36
Change from baseline in pain, disability and activity restriction in foot
Measured by foot functional index FFI
General pain
Measured by VAS pain scale
Reduction of inflammation
Measured by MRI
Click on the lead sponsor to view all of their trials.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
Luzerner Kantonsspital
Collaborator
