Focused ESWT vs. Wait-list Management for Plantar Fasciopathy: A Randomized Controlled Trial Evaluating Pain, Function, and Ultrasonographic Plantar Fascia Thickness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
This study investigates whether focused Extracorporeal Shockwave Therapy (fESWT) helps people with chronic heel pain, commonly known as plantar fasciitis. Many patients suffer from this condition for more than six months without relief.
The study compares two groups: one receiving fESWT treatment plus a specific exercise program, and a "wait-list" group that only performs the exercises at first. The shockwave treatment uses precise sound waves targeted at the painful area to stimulate the body's natural healing process.
Researchers will measure if the treatment reduces pain and improves the patient's ability to walk and perform daily activities. Additionally, ultrasound will be used to see if the thickness of the plantar fascia (the tissue under the foot) decreases and returns to a healthier state. The goal is to confirm if fESWT provides a faster and more effective recovery than exercise alone.
详细描述
This is a prospective, randomized, wait-list controlled pilot study designed to evaluate the clinical and structural effects of focused Extracorporeal Shockwave Therapy (fESWT) on chronic plantar fasciopathy.Study Design and Participants:Twenty participants with chronic plantar heel pain lasting more than six months were enrolled. Inclusion criteria required a diagnosis of plantar fasciopathy confirmed by a thickness of > 4.0 mm on ultrasound. Participants were randomized 1:1 into an Experimental Group (fESWT + High-Load Strength Training) or a Wait-list Control Group (High-Load Strength Training only).Intervention Protocol:fESWT Administration: The experimental group received three sessions of fESWT once per week. Each session consisted of 2,000 pulses at a frequency of 5-8 Hz.Energy Settings: The Energy Flux Density (EFD) was titrated based on patient tolerance, ranging from 0.10 to 0.30 mJ/mm^2, using a "point-and-shoot" technique at the site of maximal tenderness.Standard of Care: All participants followed a progressive High-Load Strength Training (HLST) protocol, performing heel raises every other day.Assessments and Follow-up:The primary outcome measures include pain intensity via the Visual Analogue Scale (VAS) and functional disability via the Foot Function Index (FFI). Secondary outcomes focus on structural remodeling of the plantar fascia measured by high-resolution ultrasound. Evaluations are conducted at baseline and at 4, 8, and 12 weeks post-intervention to track both immediate rescue effects and long-term tissue normalization.Wait-list Management:To maintain ethical standards, the wait-list control group received the fESWT intervention after the initial 4-week comparative period.
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 (Outcomes Assessor)
盲法说明
Outcomes Assessor is blinded to the group allocation. This assessor performs all ultrasonographic measurements and clinical data analysis to prevent observation bias and ensure the objective evaluation of plantar fascia structural changes
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged between 18 and 70 years. Diagnosis of chronic plantar fasciopathy with symptoms persisting for more than 6 months.
- •Presence of plantar fascia (PF) thickness > 4.0 mm, confirmed by high-resolution ultrasound.
- •Clinical history of localized pain at the medial calcaneal tubercle, specifically upon first steps in the morning or after prolonged rest.
- •Failure of previous conservative treatments (e.g., stretching, orthotics, or medication).
- •Ability to follow the High-Load Strength Training (HLST) exercise protocol.
排除标准
- •Previous treatment with shockwave therapy or corticosteroid injections in the affected foot within the last 6 months.
- •Previous surgery for plantar heel pain.
- •Presence of systemic inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis).
- •Coagulopathies or use of anticoagulant medication.
- •Local infection or presence of skin lesions at the application site.
- •Known or suspected malignancy in the treatment area.
- •Presence of neurological conditions or peripheral neuropathy (e.g., tarsal tunnel syndrome).
研究组 & 干预措施
Wait-list Control: Exercise Only
Participants in this wait-list control arm perform only the standardized High-Load Strength Training (HLST) program (progressive heel-rises every other day) during the initial 4-week comparative phase. This arm serves as the control group to evaluate the specific clinical and structural added value of fESWT. For ethical reasons, after the primary 4-week assessment is completed, these participants are offered the same fESWT protocol administered to the experimental group.
干预措施: Wait-list Control: Exercise Only (Other)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: baseline,4,8 and 12 weeks
Pain intensity will be measured using a 100-cm Visual Analogue Scale, where 0 represents "no pain" and 10 represents "the worst pain imaginable." A higher score indicates greater pain intensity.
Plantar Fascia (PF) Thickness
时间窗: Baseline, 4 weeks, 8 weeks, and 12 weeks.
The thickness of the plantar fascia will be measured in millimeters (mm) using high-resolution B-mode ultrasound. Measurements are taken approximately 1 cm distal to the calcaneal insertion. A decrease in thickness is associated with tissue remodeling and clinical recovery.
次要结局
- Foot Function Index (FFI) Score(Baseline, 4 weeks, 8 weeks, and 12 weeks.)