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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in general pain levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Current other treatment specific to the plantar fascia or intent to undergo during the trial
研究组 & 干预措施
Corticosteroid
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
干预措施: Dexamethasone (Drug)
Botulinum Toxin A (BTX-A)
20 units of Onabotulinum A in 200 µL of saline
干预措施: Botulinum Toxin A (Drug)
结局指标
主要结局
Change in general pain levels
时间窗: Baseline to 1 (primary endpoint), 3, and 6 months
Measured via patient-reported Numeric Pain Rating Scale (NPRS)
次要结局
- Number of subjects dropping out for repeat injection or surgical intervention(Baseline to 1 (primary endpoint), 3, and 6 months)
- Change in foot and ankle-induced difficulties with activities of daily living(Baseline to 1 (primary endpoint), 3, and 6 months)