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

March 26, 2025 updated by: Western Institute for Veterans Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • VA Salt Lake City Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botulinum Toxin A (BTX-A)
20 units of Onabotulinum A in 200 µL of saline
Drug: Botulinum Toxin A
20 units of Onabotulinum A in 200 µL of saline injected into the flexor digitorum brevis via ultrasound-guidance
Other Names:
  • OnabotulinumtoxinA
  • BTX-A
Active Comparator: Corticosteroid
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
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
Other Names:
  • Cortisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in general pain levels
Time Frame: Baseline to 1 (primary endpoint), 3, and 6 months
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
Time Frame: Baseline to 1 (primary endpoint), 3, and 6 months
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
Time Frame: Baseline to 1 (primary endpoint), 3, and 6 months
Measure how long therapeutic relief lasts
Baseline to 1 (primary endpoint), 3, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Institute for Veterans Research

Investigators

  • Principal Investigator: Mikol Anderson, DPM, VA Salt Lake City Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2022

Primary Completion (Actual)

September 13, 2024

Study Completion (Actual)

September 13, 2024

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00146615

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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