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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Drug: Botulinum toxin A
* Drug: cortisone
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BTX-A<br>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<br>* 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..<br>|
| Active Comparator: Cortisone<br>Depot Medrol is injected at the plantar fascia insertion site at the calcaneus | Drug: cortisone<br> <br> |
| Placebo Comparator: Saline<br>Placebo saline is injected in both gastrocnemius muscle-bellies and in the soleus muscle | Drug: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in foot pain | Measured by VAS FA subjective foot score | at 6 weeks, 3, 6 and 12 (24) months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in patient health | Measured by SF 36 | at 6 weeks, 3, 6 and 12 (24) months | 
| 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 | 
| General pain | Measured by VAS pain scale | at 6 weeks, 3, 6 and 12 (24) months | 
| Reduction of inflammation | Measured by MRI | pre-intervention and at 12 months | 
| Number of patients with complications |  | at 6 weeks, 3, 6 and 12 (24) months | 
| Change from baseline in ankle range of motion | Measured by goniometer | at 6 weeks, 3, 6 and 12 (24) months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plantar fasciitis, Botulinum toxin A, Cortisone, RCT