Study of Taping for Heel Fat Pad Syndrome (STEP): A Randomized Controlled Crossover Single-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change from pre-intervention to immediately post-intervention in Numeric Pain Rating Scale (NPRS) during the most pain-aggravating activity
研究概览
简要总结
The primary objectives of this study are to investigate the immediate and short-term effect of heel fat pad loop taping (experimental intervention) vs. control taping (control intervention) on pain and function in individuals with heel fat pad syndrome (HFPS). For mechanistic understanding of the effect of the loop taping, we will assess the immediate effect of taping on the pressure pain threshold and heel fat pad thickness.
详细描述
The study objectives are to investigate the immediate and short-term effect of heel fat pad loop taping (experimental intervention) vs. control taping (control intervention) on pain and function in individuals with heel fat pad syndrome (HFPS). We hypothesize that the fat pad loop taping is superior to control taping in immediate and short-term pain reduction and short-term function and mobility improvement. To understand potential mechanisms underlying the benefits of the looping taping, we will assess the immediate effect of taping on the pressure pain threshold and heel fat pad thickness. We hypothesize that applying fat pad loop taping will increase the pressure pain threshold (i.e., diminished pain sensitivity) recorded by a mechanical pressure algometer and increase fat pad thickness quantified by ultrasound. Despite being the second leading cause of plantar heel pain, RCTs for conservative management do not exist. Findings of this proposed project will provide much-needed evidence on effective non-pharmacological managements of HFPS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
To blind the participants, they will be told that both taping techniques have been used in the clinic and we want to investigate if they are effective and if one works better than the other.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 18 to 79 years of age
- •History of plantar heel pain in either foot for at least one week and less than 3 years before enrollment
- •Tenderness on palpation of the heel fat pad
- •Self-reported worst unilateral or bilateral central heel pain of ≥ 3 on a 0-10 Numeric Pain Rating Scale (NPRS) during the past week
- •Pain ≥ 3 on NPRS during at least one of two pain-aggravating activities of 30-sec static single leg standing OR barefoot 20-meter walking assessed during the enrollment screening and before the tape application
排除标准
- •Primary diagnoses of plantar heel pain (e.g., plantar fasciopathy, posterior tibialis tendinopathy, or tarsal tunnel syndrome) other than HFPS
- •Ultrasound-measured plantar fascia thickness ≥ 4mm, combined with clinical presentations of plantar fasciopathy
- •Systemic inflammatory arthritis
- •Lumbar radiculopathy
- •Neurological conditions affecting gait and mobility
- •Having received taping for HFPS within the last month
- •Prior heel surgery
研究组 & 干预措施
Control taping
Control taping of the heel fat pad
干预措施: Control taping (Other)
Loop taping
Loop taping of the heel fat pad
干预措施: Loop taping (Other)
结局指标
主要结局
Change from pre-intervention to immediately post-intervention in Numeric Pain Rating Scale (NPRS) during the most pain-aggravating activity
时间窗: pre-intervention, immediately post-intervention
The primary outcome is pain experienced during the most pain-aggravating activity (e.g., 30-sec static single leg standing or 20-meter barefoot walking) reported during the initial visit. Participants verbally select a value that corresponds with the intensity of pain that they experience. "0" means "no pain" and "10" means "pain as bad as you can imagine" or "worst pain imaginable". The NPRS, an 11-point (i.e., 0-10) measure of pain intensity, is recommended as a core outcome measure in clinical trials of chronic pain treatments and has excellent reliability and validity for adults with chronic musculoskeletal pain.
次要结局
- Change from pre-intervention to 3 days post-intervention in Foot Health Status Questionnaire (FHSQ)(pre-intervention, 3 days post-intervention)
- Change from pre-intervention to immediately post-intervention in Heel fat pad thickness(pre-intervention, immediately post-intervention)
- Change from pre-intervention to 3 days post-intervention in Numeric Pain Rating Scale (NPRS) in the past 24 hours(pre-intervention, 3 days post-intervention)
- Global Rating of Change (GROC)(3 days post-intervention)
- Change from pre-intervention to immediately post-intervention in Pain sensitivity by pressure pain thresholds(pre-intervention, immediately post-intervention)
研究者
Alison Chang
Associate Professor
Northwestern University