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

Phase 2

Completed

• Conditions: Plantar Fasciitis
• Interventions: Drug: Botulinum Toxin A; Drug: Dexamethasone

• Registration Number: NCT05367271
• Lead Sponsor: Western Institute for Veterans Research

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-10
• Study Start: 2022-08-23
• Primary Completion: 2024-09-13
• Study Completion: 2024-09-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin A (BTX-A)	Botulinum Toxin A	20 units of Onabotulinum A in 200 µL of saline
Corticosteroid	Dexamethasone	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VA Salt Lake City Health Care System; 🇺🇸 Salt Lake City, Utah, United States