The Efficacy of Botulinum Toxin vs. Corticosteroid for the Treatment of Refractory Plantar Fasciitis

Study Overview
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Brief Summary
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This single-blinded, randomized-controlled trial compares the efficacy of ultrasound-guided onabotulinumtoxinA (BTX-A) injections to the flexor digitorum brevis with current standard of care corticosteroid injections to the plantar fascia for the treatment of refractory plantar fasciitis in patients that have failed six weeks of non-operative treatment.

Detailed Description
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Treatment of plantar fasciitis is not well described in the current literature, often making management difficult for both providers and patients. Recent literature has suggested potential use of Onabotulinumtoxin A (BTX-A) as an effective treatment to reduce pain and allow patients to return to their previous level of functional activity. The study will consist of veteran patients at the George E Wahlen Department of Veteran's Affairs (SLC VA) in Salt Lake City, UT. This pilot study aims to randomize patients with plantar fasciitis into current standard of care treatment with corticosteroid injection into the plantar fascia and experimental treatment with BTX-A injection into the flexor digitorum brevis cohorts. We predict that those who receive BTX-A injections will report better outcomes on the Numeric Pain Rating Scale (NPRS) as well as the Foot and Ankle Ability Measure (FAAM) when compared to those receiving corticosteroid. The results of this study could aid in providing evidence towards more reliable and beneficial treatment of plantar fasciitis.

Official Title
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The Efficacy of Botulinum Toxin to the Flexor Digitorum Brevis Versus Corticosteroid to the Plantar Fascia for the Treatment of Refractory Plantar Fasciitis: A Randomized-Controlled Trial

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Drug: Botulinum Toxin A
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed increased pain when pressure applied at the medial calcaneal tubercle X-ray negative for calcaneal fractures or tumors Patient with plantar fasciitis who have failed 6 weeks of non-operative treatment Exclusion Criteria: Prior botulinum toxin injections in the plantar fascia Any botulinum toxin injections in the past 3 months Cortisone injection in the plantar fascia in the previous 3 months Previous surgery on the plantar fascia Active workers compensation claim for plantar fasciitis Active infection or fever Botox or steroid allergy Pregnancy Current other treatment specific to the plantar fascia or intent to undergo during the trial

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum Toxin A (BTX-A)<br>20 units of Onabotulinum A in 200 µL of saline | Drug: Botulinum Toxin A<br>* 20 units of Onabotulinum A in 200 µL of saline injected into the flexor digitorum brevis via ultrasound-guidance<br>* Other names: BTX-A;|
| Active Comparator: Corticosteroid<br>1 mL of 4 mg/mL dexamethasone with 2 mL of 1% lidocaine OR 1 mL of 4 mg/mL dexamethasone, 1 mL of 2% lidocaine and 1 mL saline | Drug: Dexamethasone<br>* 1 mL of 4 mg/mL dexamethasone with 2 mL of 1% lidocaine OR 1 mL of 4 mg/mL dexamethasone, 1 mL of 2% lidocaine and 1 mL saline injected into the plantar fascia<br>* Other names: Cortisone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in general pain levels | Measured via patient-reported Numeric Pain Rating Scale (NPRS) | Baseline to 1 (primary endpoint), 3, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in foot and ankle-induced difficulties with activities of daily living | Measured via patient-reported Foot and Ankle Ability Measure (FAAM) | Baseline to 1 (primary endpoint), 3, and 6 months | 
| Number of subjects dropping out for repeat injection or surgical intervention | Measure how long therapeutic relief lasts | Baseline to 1 (primary endpoint), 3, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OnabotulinumtoxinA, Botulinum Toxin A, Plantar fasciitis, Corticosteroid