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

Western Institute for Veterans Research62 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Plantar Fasciitis

Interventions

Botulinum Toxin ADRUG

20 units of Onabotulinum A in 200 µL of saline injected into the flexor digitorum brevis via ultrasound-guidance

DexamethasoneDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosed increased pain when pressure applied at the medial calcaneal tubercle 2. X-ray negative for calcaneal fractures or tumors 3. Patient with plantar fasciitis who have failed 6 weeks of non-operative treatment Exclusion Criteria: 1. Prior botulinum toxin injections in the plantar fascia 2. Any botulinum toxin injections in the past 3 months 3. Cortisone injection in the plantar fascia in the previous 3 months 4. Previous surgery on the plantar fascia 5. Active workers compensation claim for plantar fasciitis 6. Active infection or fever 7. Botox or steroid allergy 8. Pregnancy 9. Current other treatment specific to the plantar fascia or intent to undergo during the trial

Locations (1)

VA Salt Lake City Health Care System

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Change in general pain levels

Measured via patient-reported Numeric Pain Rating Scale (NPRS)

Time frame: Baseline to 1 (primary endpoint), 3, and 6 months

Secondary Outcomes

Change in foot and ankle-induced difficulties with activities of daily living

Measured via patient-reported Foot and Ankle Ability Measure (FAAM)

Time frame: 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

Time frame: Baseline to 1 (primary endpoint), 3, and 6 months

Data from ClinicalTrials.gov

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