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

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02196155
• Other study ID #: 32003B_152671
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: University Hospital Inselspital, Berne
• Contact: Fabian Krause, PD Dr.
• Phone: 0041316322220
• Email: fabian.krause[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background

Plantar fasciitis is the classic and most common type of heel pain. Extrapolating the rate of 2 million or 0.6% of the US American population being treated for plantar fasciitis every year to Switzerland, the corresponding number of patients would amount to 50'000 patients being treated for plantar fasciitis. 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. In the literature, numerous operative and nonoperative treatment approaches for plantar fasciitis have been suggested. 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. Numerous prescriptions for unnecessary orthoses, expensive and painful shock waves, and complications following steroid injection could be obviated, when the safe BTX-A injection demonstrates good results.

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).

The high number of level I and II studies suggests that there is need for clarification and evaluation of the efficacy of several non-operative and operative treatment approaches for the chronic plantar fasciitis. 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. Objective evaluation of the BTX-A efficacy includes the randomized allocation of patients to the BTX-A, the steroid, or the saline group, the blinded comparison to the sham (saline) injection, and finally the MRI assessment at the beginning and at the end of the followup. With the evidence resulting from this study, patients can be superiorly counseled in the future with regard to efficacy of nonoperative treatment of plantar fasciitis.

Objective

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. 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.

Methods

Patients are randomly allocated to three groups (1 - 3).

• Patient group 1 - combination of physiotherapy, stretching exercises according to DiGiovanni et al and BTX-A injection into the gastroc-soleus complex: One hundred units (U) of toxin are applied to each muscle belly, and 1 application of 50 U is administered to the soleus, making a total of 250 U.

• Patient group 2 - physiotherapy, stretching exercises according to DiGiovanni combined with cortisone injection into the plantar fascia

• Patient group 3 - physiotherapy, stretching exercises according to DiGiovanni and saline injection into the gastroc-soleus complex (sham control group)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

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..
• cortisone

• Saline

Locations

Country	Name	City	State
Switzerland	Dep, of Orthopaedic Surgery, Inselspital, University of Berne	Berne
Switzerland	Department of Orthopaedic Surgery, Kantonsspital Lucerne	Lucerne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View Citation

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 — View Citation

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 An — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in foot pain	Measured by VAS FA subjective foot score	at 6 weeks, 3, 6 and 12 (24) months
Secondary	Change from baseline in patient health	Measured by SF 36	at 6 weeks, 3, 6 and 12 (24) months
Secondary	Change from baseline in pain, disability and activity restriction in foot	Measured by foot functional index FFI	at 6 weeks, 3, 6 and 12 (24) months
Secondary	General pain	Measured by VAS pain scale	at 6 weeks, 3, 6 and 12 (24) months
Secondary	Reduction of inflammation	Measured by MRI	pre-intervention and at 12 months
Secondary	Number of patients with complications		at 6 weeks, 3, 6 and 12 (24) months
Secondary	Change from baseline in ankle range of motion	Measured by goniometer	at 6 weeks, 3, 6 and 12 (24) months