CompletedPhase 2/3

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

United States62 participantsStarted 2022-08-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in general pain levels

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

Trial details

NCT IDNCT05367271

SponsorWestern Institute for Veterans Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-13

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