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Completed

NCT Number: NCT05367271

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

VA Salt Lake City Health Care System

Salt Lake City, Utah, 84148, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin A

Drug

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

Other names: OnabotulinumtoxinA, BTX-A

Dexamethasone

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Western Institute for Veterans Research

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 10, 2022
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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