Plantar Fasciitis
Conditions
Keywords
OnabotulinumtoxinA, Botulinum Toxin A, Plantar fasciitis, Corticosteroid
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.
Interventions
DRUGBotulinum Toxin A
20 units of Onabotulinum A in 200 µL of saline injected into the flexor digitorum brevis via ultrasound-guidance
DRUGDexamethasone
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
Sponsors
Western Institute for Veterans Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in general pain levels | Baseline to 1 (primary endpoint), 3, and 6 months | Measured via patient-reported Numeric Pain Rating Scale (NPRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in foot and ankle-induced difficulties with activities of daily living | Baseline to 1 (primary endpoint), 3, and 6 months | Measured via patient-reported Foot and Ankle Ability Measure (FAAM) |
| Number of subjects dropping out for repeat injection or surgical intervention | Baseline to 1 (primary endpoint), 3, and 6 months | Measure how long therapeutic relief lasts |
Countries
United States
Outcome results
None listed