Clinical trial NCT02196155: Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis
Official title: Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fasciitis
Keywords: plantar fasciitis
Botulinum toxin A
Cortisone
RCT
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Luzerner Kantonsspital
First posted: 2014-07-21
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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)

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

Primary outcomes:
measure: Change from baseline in foot pain
timeFrame: at 6 weeks, 3, 6 and 12 (24) months
Secondary outcomes:
measure: Change from baseline in patient health
timeFrame: at 6 weeks, 3, 6 and 12 (24) months
measure: Change from baseline in pain, disability and activity restriction in foot
timeFrame: at 6 weeks, 3, 6 and 12 (24) months
measure: General pain
timeFrame: at 6 weeks, 3, 6 and 12 (24) months
measure: Reduction of inflammation
timeFrame: pre-intervention and at 12 months
measure: Number of patients with complications
timeFrame: at 6 weeks, 3, 6 and 12 (24) months
measure: Change from baseline in ankle range of motion
timeFrame: at 6 weeks, 3, 6 and 12 (24) months
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Dep, of Orthopaedic Surgery, Inselspital, University of Berne
city: Lucerne
country: Switzerland
facility: Department of Orthopaedic Surgery, Kantonsspital Lucerne
Study officials:
affiliation: Dep. of Orthopaedic Surgery, Inselspital, University of Berne, Freiburgstrasse, 3010 Berne, Switzerland
name: Fabian Krause, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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 Ankle Int. 2013 Jan;34(1):8-14. doi: 10.1177/1071100712460215.