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临床试验/NCT06987721
NCT06987721已完成不适用

Comparison of the Efficacy of Radial and Focused Extracorporeal Shock-wave Therapy (ESWT) in Myofascial Pain Syndrome: Prospective, Randomized, Sham Controlled Study

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2022年1月18日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Numerical Rating Scale

研究概览

简要总结

Introduction: Myofascial pain syndrome (MPS) is a syndrome characterized by painful trigger points on palpation located at certain points of common muscles of the musculoskeletal system. Active trigger points may cause spontaneous pain and many other consequences that affect quality of life and loss of work force. Extracorporeal shock-wave therapy (ESWT) is a treatment method performed with the help of acoustic waves created outside the body and used in musculoskeletal problems. There are radial or focused waves that are commonly used in ESWT. In Focused ESWT (F-ESWT), the depth of the body part to be injured can be adjusted. Thus, penetration into the tissue is better than radial waves. Radial ESWT (R-ESWT), on the other hand, has a more superficial effect, and its spread in liquids with a density similar to tissues is half that of focused ESWT. It has been shown in previous studies that radial and focused ESWT waves applied to trigger points in the upper trapezius fibers reduce reflected and local pain in myofascial pain syndrome. The aim of this study is to compare the effectiveness of radial and focused ESWT types on trigger points in trapezoidal upper fibers in myofascial pain syndrome.

Methods: This prospective,sham-controlled double-blind study was carried out with total of 57 patients. They were randomized into 3 groups and received R-ESWT, F-ESWT and sham protocols for 10 sessions. Patients were evaluated and compared with Numerical rating scale (NRS), Health assessment Questionnaire (HAQ) and Beck Depression Scale (BDI) before treatment, just post treatment, 1st month, 3nd month and 6th month after treatment completed.

详细描述

Myofascial pain syndrome (MPS) is a syndrome characterized by painful trigger points on palpation located at certain points of common muscles of the musculoskeletal system. Pain on palpation tends to radiate and is sometimes even accompanied by sensory symptoms (such as paresthesia) or autonomic findings (piloerection, sweating, etc.). Trigger points can be either latent or active. Active trigger points may cause spontaneous pain, while latent trigger points are more commonly manifested as pain radiating with palpation. Latent trigger points tend to turn into active trigger points as a result of acute stresses, microtraumas or postural disorders, and the trapezius muscle is the most common muscle in which myofascial trigger points are seen. Myofascial pain syndrome can cause many consequences such as disturbances in daily living acitivities, decrease in quality of life and loss of work force. It can also accompany anxiety and depression . Pharmacological therapy can be used in the treatment, since stretching exercises, dry needling, acupuncture or physical therapy modalities are another effective treatment options for patients who are not willing to use drugs or have co-morbidities .

Extracorporeal shock-wave therapy (ESWT) is a kind of physical therapy method performed with the help of acoustic waves created outside the body. It is frequently used in musculoskeletal conditions. Its effectiveness has been demonstrated in disorders such as calcaneal spur, lateral epicondylitis, calcific tendinitis, myofascial pain syndrome, and fibromyalgia .

Radial or focused waves are commonly used in application of ESWT. In Focused ESWT (F-ESWT), the depth of the body part to be injured can be adjusted. Thus, penetration into the tissue is better than radial waves. Radial ESWT (R-ESWT), on the other hand, has a more superficial effect, and its spread in liquids with a density similar to tissues is half that of F-ESWT . However some side effects were identified during the ESWT procedure, both wave types are thought to be safe and widely used.

It has been shown in previous studies that radial and focused ESWT waves applied to trigger points in the upper trapezius fibers reduce reflected and local pain in myofascial pain syndrome. The effectiveness of these waves has been evaluated in studies many times but the effectiveness of the two wave types has not been compared in patients with trigger points in the trapezius upper fibers in myofascial pain syndrome. The aim of this study is to compare the efficacy of R-ESWT and F-ESWT types on trigger points in trapezoidal upper fibers in myofascial pain syndrome.

This prospective, sham-controlled and double-blind study was carried out at Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital. Fifty nine male and/or female patients enrolled the study initially. The study protocol is compatible with Helsinki declaration and approved by Ankara Bilkent City Hospital Ethics Committee (Approval number: E2-22-3033). Written and oral informed consents were obtained from the participants before allocation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

入选标准

  • Patients aged between 18-70 years with myofascial pain syndrome and active trigger points in the trapezius upper fibers
  • Pain related to trapezius muscle trigger points were > 4 according to numerical rating scale (NRS)

排除标准

  • Revealed any cervical disc herniation (protrusion or extrusion) that cause cervical root compression showed with magnetic resonance imaging and/or radicular pain with motor or sensory deficit
  • Presence of neurological and rheumatological disorders and/or malignancy
  • Detected cognitive impairment according to mini mental test (mini mental test score <23)
  • Acute systemic infection or any other diseases that effect general condition
  • Participants have any open wound or sensory deficit in the application area.

结局指标

主要结局

Numerical Rating Scale

时间窗: Before treatment, just post treatment, 1st month, 3nd month and 6th month after treatment completed.

Numerical rating scale (NRS) (0-10 scores) is used by patients to perform a self-assessment of pain intensity associated with myofascial pain syndrome. Higher scores indicates more pain related to trigger points of upper trapezius muscle fibers

次要结局

  • Beck Depression Inventory(Before treatment, just post treatment, 1st month, 3nd month and 6th month after treatment completed.)
  • Health Assessment Questionnaire(Before treatment, just post treatment, 1st month, 3nd month and 6th month after treatment completed.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hüma Bölük Şenlikci

Associate Professor

Ankara City Hospital Bilkent

研究点 (1)

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