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

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ClinicalTrials.gov Identifier: NCT02196155
Recruitment Status : Recruiting
First Posted : July 21, 2014
Last Update Posted : October 3, 2018
Sponsor:
Collaborator:
Luzerner Kantonsspital
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
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
Drug: cortisone
Placebo Comparator: Saline
Placebo saline is injected in both gastrocnemius muscle-bellies and in the soleus muscle
Drug: Saline



Primary Outcome Measures :
  1. Change from baseline in foot pain [ Time Frame: at 6 weeks, 3, 6 and 12 (24) months ]
    Measured by VAS FA subjective foot score


Secondary Outcome Measures :
  1. Change from baseline in patient health [ Time Frame: at 6 weeks, 3, 6 and 12 (24) months ]
    Measured by SF 36

  2. 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

  3. General pain [ Time Frame: at 6 weeks, 3, 6 and 12 (24) months ]
    Measured by VAS pain scale

  4. Reduction of inflammation [ Time Frame: pre-intervention and at 12 months ]
    Measured by MRI

  5. Number of patients with complications [ Time Frame: at 6 weeks, 3, 6 and 12 (24) months ]
  6. Change from baseline in ankle range of motion [ Time Frame: at 6 weeks, 3, 6 and 12 (24) months ]
    Measured by goniometer



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Fabian Krause, PD Dr. 0041316322220 fabian.krause@insel.ch

Locations
Switzerland
Dep, of Orthopaedic Surgery, Inselspital, University of Berne Recruiting
Berne, Switzerland, 3010
Contact: Fabian Krause, PD Dr.    0041316322220    fabian.krause@insel.ch   
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    lukas.iselin@luks.ch   
Principal Investigator: Lukas Iselin, Dr.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Luzerner Kantonsspital
Investigators
Principal Investigator: Fabian Krause, PD Dr. Dep. of Orthopaedic Surgery, Inselspital, University of Berne, Freiburgstrasse, 3010 Berne, Switzerland

Publications of Results:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02196155     History of Changes
Other Study ID Numbers: 32003B_152671
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

Keywords provided by University Hospital Inselspital, Berne:
plantar fasciitis
Botulinum toxin A
Cortisone
RCT

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Cortisone acetate
Cortisone
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents