The Efficacy of Botulinum Toxin vs. Corticosteroid for the Treatment of Refractory Plantar Fasciitis
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2022
CompletedFirst Posted
Study publicly available on registry
May 10, 2022
CompletedStudy Start
First participant enrolled
August 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2024
CompletedApril 2, 2025
March 1, 2025
2.1 years
May 5, 2022
March 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in general pain levels
Measured via patient-reported Numeric Pain Rating Scale (NPRS)
Baseline to 1 (primary endpoint), 3, and 6 months
Secondary Outcomes (2)
Change in foot and ankle-induced difficulties with activities of daily living
Baseline to 1 (primary endpoint), 3, and 6 months
Number of subjects dropping out for repeat injection or surgical intervention
Baseline to 1 (primary endpoint), 3, and 6 months
Study Arms (2)
Botulinum Toxin A (BTX-A)
EXPERIMENTAL20 units of Onabotulinum A in 200 µL of saline
Corticosteroid
ACTIVE COMPARATOR1 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
Interventions
20 units of Onabotulinum A in 200 µL of saline injected into the flexor digitorum brevis via ultrasound-guidance
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Salt Lake City Health Care System
Salt Lake City, Utah, 84148, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mikol Anderson, DPM
VA Salt Lake City Health Care System
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2022
First Posted
May 10, 2022
Study Start
August 23, 2022
Primary Completion
September 13, 2024
Study Completion
September 13, 2024
Last Updated
April 2, 2025
Record last verified: 2025-03