Effectiveness of Percutaneous Electrolysis Treatment Targeting the Muscle-Fascia Chain in Chronic Plantar Fasciitis: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity (VAS)
研究概览
简要总结
The aim of this study is to compare, in terms of treatment effectiveness, a control group receiving a combination of a conventional exercise program and percutaneous electrolysis applied to the plantar fascia with an intervention group receiving a combination of a conventional exercise program plus percutaneous electrolysis applied both to the plantar fascia and to myofascial trigger points in the gastrosoleus muscles. Patients participating in the study will be randomized into two groups. Both groups will receive a conventional home exercise program. In the intervention group, percutaneous electrolysis treatment will be applied to both the plantar fascia and the trigger points of the gastrosoleus muscles. In the control group, percutaneous electrolysis treatment will be applied only to the plantar fascia. The percutaneous electrolysis treatment protocol will be administered on the 1st, 8th and 14th days of treatment under ultrasound guidance, using 0.3-millimeter acupuncture needles and an EPTE® percutaneous electrolysis device (Ionclinics & A. Deionic SL, Valencia, Spain) at an intensity of 350 µA for 80 seconds. The conventional home exercise program will include plantar fascia and Achilles tendon stretching, ball or cylinder rolling, and towel-grasping exercises targeting the intrinsic foot muscles. Patients' subjective pain intensity will be assessed using the Visual Analog Scale (VAS), pressure pain threshold using an algometer, functional level using the Foot Function Index (FFI), tissue parameters using ultrasound, and maximum standing and walking times without heel pain; all outcomes will be measured and recorded before treatment, after treatment, and three months after the start of treatment. The aim of the study is to compare, in terms of treatment effectiveness, the control group receiving a combination of a conventional exercise program and percutaneous electrolysis applied to the plantar fascia with the intervention group receiving a combination of a conventional exercise program plus percutaneous electrolysis applied to both the plantar fascia and the myofascial trigger points in the gastrosoleus muscles.
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
- None
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
- •Patients who agree to participate in the study, are between 18 and 70 years of age, have had symptoms for at least 6 weeks, and have a diagnosis of plantar fasciitis confirmed clinically (sharp pain on the plantar surface of the foot upon standing after rest, heel pain that is most severe with the first steps in the morning and decreases with mild activity) and by ultrasonography (plantar fascia thickness recorded as >4 mm on ultrasound), who have not previously received any medical treatment for the condition, who agree not to use anti-inflammatory drugs during the treatment period, who have normal blood laboratory findings, who have no known acute or chronic inflammatory disease, who have a level of education sufficient to understand the treatment and procedures applied, and who are able to complete the treatment evaluation forms will be included in the study.
排除标准
- •Patients with malignancy, active infection, a history of systemic inflammatory rheumatic disease, trauma, skin lesions, infection or open wounds on the foot, neuropathy, radiculopathy, peripheral circulatory disorders, coagulopathy, warfarin use, arthropathy, congenital or acquired lower extremity deformity, sequelae of lower extremity fracture, the presence of a prosthesis, internal plate or screw fixation, a cardiac pacemaker, a metal implant in the treatment area, conditions that contraindicate physiotherapy such as pregnancy, or metal allergy will not be included in the study.
结局指标
主要结局
Change in Pain Intensity (VAS)
时间窗: Baseline (before treatment), immediately after completion of the 3rd treatment session (approximately 2 weeks), and 3 months after treatment initiation.
Pain intensity related to plantar heel pain will be assessed using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain.
Change in Pain Intensity (VAS)
时间窗: Baseline (before treatment), immediately after completion of the 3rd treatment session (approximately 2 weeks), and 3 months after treatment initiation.
Pain intensity related to plantar heel pain will be assessed using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain.
次要结局
- Change in Pressure Pain Threshold (Algometry)(Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.)
- Change in Functional Status (Foot Function Index - FFI)(Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.)
- Change in Ultrasound Tissue Parameters of the Plantar Fascia(Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.)
- Change in Maximum Pain-Free Standing and Walking Time(Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.)
- Change in Pressure Pain Threshold (Algometry)(Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.)
- Change in Functional Status (Foot Function Index - FFI)(Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.)
- Change in Ultrasound Tissue Parameters of the Plantar Fascia(Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.)
- Change in Maximum Pain-Free Standing and Walking Time(Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.)
研究者
Serkan Polat
MD
Sivas State Hospital