Clinical trial

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

NCT02196155

Name

32003B_152671

Description

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.

Trial arms

Trial start

2016-07-01

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Recruiting

Treatment

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..

Arms:

BTX-A

cortisone

Arms:

Cortisone

Saline

Arms:

Saline

Size

Primary endpoint

Change from baseline in foot pain

at 6 weeks, 3, 6 and 12 (24) months

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 54, 'type': 'ESTIMATED'}}

Updated at

2023-02-22

1 organization

2 products

1 drug

1 indication

Organization

Product

Indication

Product

Drug