Comparison of Treatment Efficacy of Extracorporeal Shockwave Therapy (ESWT) and Myofascial Release Techniques in Patients With Plantar Fasciitis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AHFS)
研究概览
简要总结
Various treatment methods are employed for patients diagnosed with plantar fasciitis. However, many of these approaches involve high-cost interventions, such as extracorporeal shock wave therapy (ESWT) and platelet-rich plasma (PRP) applications. The present study aims to compare the treatment effectiveness of myofascial release-considered a cost-effective intervention-with ESWT, which is among the most commonly preferred treatment modalities.
详细描述
The present study aims to compare the effectiveness of extracorporeal shock wave therapy (ESWT), a frequently used treatment for patients with plantar fasciitis and heel pain, with specific myofascial release techniques. The paucity of studies in the literature and the lack of definitive evidence on this topic served as the basis for initiating this research. A total of 114 patients diagnosed with plantar fasciitis, deemed appropriate for ESWT and myofascial release therapy and meeting the inclusion criteria, are planned to participate in the study. These 114 patients will be randomly divided into three groups of 38 each. Before and after treatment, each patient will complete a demographic data form, the Visual Analog Scale (VAS), the Foot Function Index (FFI), the Roles and Maudsley pain scores, and the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot clinical assessment scales. Participants will be randomly selected from among individuals who applied to Kayseri City Hospital with complaints of plantar fasciitis within the Kayseri province. The three groups will consist of a myofascial release treatment group, an ESWT treatment group, and a control group. The ESWT group will receive 2,000 pulses per session at 2.0 bar intensity, 14 Hz frequency, and a dose of 0.2 mJ/mm². Specific myofascial release techniques will be administered to the myofascial release group once per week for 16 minutes, over a total period of 5 weeks. No treatment will be administered to the control group. An evaluation appointment will be scheduled 5 weeks after baseline data collection using the designated assessment tools. Pre-treatment and post-treatment data for all three groups will be recorded using the SPSS software. After data collection is completed, appropriate statistical analyses will be conducted.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Being over 18 years old
- •Being able to communicate in Turkish
- •Being able to read and write
- •Voluntarily agreeing to participate in the study
- •Having been diagnosed with plantar fasciitis
排除标准
- •Obvious major foot trauma
- •Pregnancy
- •Presence of tumor
- •Coagulation disorder
- •Presence of open wounds and extreme sensitivity in the foot area
- •Having had any surgical operation on the foot and ankle
- •Partial amputation of the foot
- •Application of one and/or more physical medicine modalities and corticosteroid injections within the last 6 weeks
研究组 & 干预措施
ESWT treatment group
Patients in the ESWT group will receive a total of five sessions of ESWT, once a week for five weeks. The ESWT group will receive 2000 pulses per session at 14 Hz, 2.0 barr intensity, and a dose of 0.2 mJ/mm2. ESWT will be applied primarily to areas near the calcaneal insertion of the plantar fascia.
干预措施: extracorporeal shockwave therapy (Device)
myofascial release treatment group
Myofascial Release treatment group patients will receive treatments once a week for 5 weeks, for a total of 5 weeks. Treatments will be applied once a week for 5 weeks. The following will be applied for a total of 16 minutes: 2 minutes of constant pressure with the therapist's two thumbs to the center of the central part of the plantar fascia and the calcaneal insertion point; 2 minutes of constant pressure with the therapist's thumb to the lateral and medial parts of the plantar fascia, along the line, progressing anteriorly as the fascial tissue relaxes; 2 minutes of constant pressure with the therapist's thumb to the gastrocnemius muscle at its most swollen or taut point, progressing from caudal to cranial with constant pressure from the caudal to cranial point as the tissue relaxes; 2 minutes of constant pressure with the therapist's fist to the central tendon of the plantar fascia; and 2 minutes of constant pressure with the therapist's fist to the gastrocnemius muscle, from caud
干预措施: myofascial release technique (Other)
control group
Control group patients will not receive any treatment. After the data used in the study is collected, an appointment will be scheduled for five weeks later for comparison. Data will be collected and recorded again after five weeks.
干预措施: Placebo Control (Other)
结局指标
主要结局
American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS-AHFS)
时间窗: pre-treatment, 1st week post-treatment and 6th week post-treatment
The AOFAS-hindfoot clinical assessment system grades the ankle, subtalar, talonavicular, and calcaneocuboid joint levels. A patient can receive a score of 100 if they have no pain, full sagittal and hindfoot range of motion, no instability in the ankle or hindfoot, good alignment, the ability to walk more than six blocks, the ability to walk on any walking surface, no noticeable limp, no limitations in daily or recreational activities, and no need for assistive devices for ambulation. The scale includes 50 points for function, 40 points for pain, and 10 points for alignment. Increasing scores indicate that the patient's condition is good.
Foot Function İndex (FFİ)
时间窗: pre-treatment, 1st week post-treatment and 6th week post-treatment
447 / 5.000 The Foot Function Index (FFI) is a questionnaire that assesses multiple dimensions of foot function. The FFI consists of 23 items divided into three subscales that measure the impact of foot pathology on pain, disability, and activity limitation. The Foot Function Index is widely used in various pathologies and treatments related to foot and ankle problems, including congenital, acute, and chronic diseases, injuries, and surgical procedures. Increasing scores indicate that the patient's condition is good.
Visual Analog Scale (VAS)
时间窗: pre-treatment, 1st week post-treatment and 6th week post-treatment
This scale was created to assess the severity of pain in patients. Patients will be asked to rate their heel and sole pain on a scale of 1 to 10. 10 represents severe, function-limiting, and unbearable pain, while 0 represents no pain at all.
次要结局
- Roles and Maudsley pain score(pre-treatment, 1st week post-treatment and 6th week post-treatment)
研究者
Burak YİGİT
principal investigator
Istanbul Rumeli University