Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis

NCT02196155 | Recruiting DMC

• 1 other identifier: 32003B_152671
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Plantar Fasciitis

Keywords

plantar fasciitis; Botulinum toxin A; Cortisone; RCT

Outcome Measures

Primary Outcomes (1)

• Change from baseline in foot pain

  Measured by VAS FA subjective foot score

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

Secondary Outcomes (6)

• Change from baseline in patient health

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

• Change from baseline in pain, disability and activity restriction in foot

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

• General pain

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

• Reduction of inflammation

  pre-intervention and at 12 months

• Number of patients with complications

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

Study Arms (3)

BTX-A

ACTIVE COMPARATOR

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

Cortisone

ACTIVE COMPARATOR

Depot Medrol is injected at the plantar fascia insertion site at the calcaneus

Drug: cortisone

Saline

PLACEBO COMPARATOR

Placebo saline is injected in both gastrocnemius muscle-bellies and in the soleus muscle

Drug: Saline

Interventions

Botulinum toxin A DRUG

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..

BTX-A

cortisone DRUG

Cortisone

Saline DRUG

Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical symptoms of a plantar fasciitis
• Plantar fasciitis in MRI
• Symptoms more than 3 months
• Absolution of 3 months unsuccessful treatment
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Luzerner Kantonsspital: collaborator

Study Sites (2)

Dep, of Orthopaedic Surgery, Inselspital, University of Berne

Bern, 3010, Switzerland

RECRUITING

Department of Orthopaedic Surgery, Kantonsspital Lucerne

Lucerne, 6000, Switzerland

RECRUITING

Related Publications (3)

• Brin MF, Lew MF, Adler CH, Comella CL, Factor SA, Jankovic J, O'Brien C, Murray JJ, Wallace JD, Willmer-Hulme A, Koller M. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia. Neurology. 1999 Oct 22;53(7):1431-8. doi: 10.1212/wnl.53.7.1431.

  PMID: 10534247 RESULT

• Bihari K. Safety, effectiveness, and duration of effect of BOTOX after switching from Dysport for blepharospasm, cervical dystonia, and hemifacial spasm dystonia, and hemifacial spasm. Curr Med Res Opin. 2005 Mar;21(3):433-8. doi: 10.1185/030079905X36396.

  PMID: 15811212 RESULT

• Elizondo-Rodriguez J, Araujo-Lopez Y, Moreno-Gonzalez JA, Cardenas-Estrada E, Mendoza-Lemus O, Acosta-Olivo C. A comparison of botulinum toxin a and intralesional steroids for the treatment of plantar fasciitis: a randomized, double-blinded study. Foot Ankle Int. 2013 Jan;34(1):8-14. doi: 10.1177/1071100712460215.

  PMID: 23386757 RESULT

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Botulinum Toxins, Type A; Cortisone; Sodium Chloride

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Fabian Krause, PD Dr.

  Dep. of Orthopaedic Surgery, Inselspital, University of Berne, Freiburgstrasse, 3010 Berne, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabian Krause, PD Dr.

CONTACT

0041316322220; fabian.krause@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: July 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CH (2)