Clinical trial NCT05367271: The Efficacy of Botulinum Toxin vs. Corticosteroid for the Treatment of Refractory Plantar Fasciitis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Plantar Fasciitis
Keywords: OnabotulinumtoxinA
Botulinum Toxin A
Plantar fasciitis
Corticosteroid
Lead sponsor: Western Institute for Veterans Research
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in general pain levels
timeFrame: Baseline to 1 (primary endpoint), 3, and 6 months
Secondary outcomes:
measure: Change in foot and ankle-induced difficulties with activities of daily living
timeFrame: Baseline to 1 (primary endpoint), 3, and 6 months
measure: Number of subjects dropping out for repeat injection or surgical intervention
timeFrame: Baseline to 1 (primary endpoint), 3, and 6 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System
state: Utah
Study officials:
affiliation: VA Salt Lake City Health Care System
name: Mikol Anderson, DPM
role: PRINCIPAL_INVESTIGATOR
References: