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临床试验/NCT04287517
NCT04287517已完成不适用

Efficacy of Capacitive-Resistive Therapy on the Treatment of Neck/Upper Trapezius Myofascial Pain: A Randomized Double-Blind Placebo-Controlled Study

Istanbul University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Visual Analog Scale (VAS) Score Change

研究概览

简要总结

Myofascial pain syndrome (MPS) is a painful musculoskeletal condition affecting the individuals' daily life presenting with muscle spasm, referred pain patterns, stiffness, restricted range of motion caused by trigger points. Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves. Currently, although this modality is used to treat various acute or chronic musculoskeletal disorders, there is no specific data about myofascial trigger points in the literature. The investigators aimed to evaluate the efficacy of capacitive-resistive diathermy on the myofascial trigger point of neck/upper trapezius muscle area compared with the sham intervention of capacitive-resistive diathermy.

Volunteers with active myofascial trigger points in the upper trapezius and neck were included the study after being examined by sports medicine specialists. Exclusion criteria were fibromyalgia, discal hernia, radiculopathy, myelopathy, having received trigger point injection and physical therapy within the last 1 month, neck or back surgery, rheumatismal diseases, pregnancy. Patients were randomly allocated into two groups. Group 1 will be treated with capacitive resistive diathermy and exercise. Group 2 will be treated with placebo (sham) capacitive-resistive diathermy and exercise for 10 sessions at intervals of 24-48 hours. Visual analog scale (VAS), neck disability index (NDI) score, cervical range of motion (cROM), active trigger point numbers will be evaluated before and after treatment. The study was designed as a prospective, randomized, placebo-controlled double-blind trial. The study was approved by the Istanbul Faculty of Medicine Ethics Committee. All participants were informed of the study and signed written informed consent.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteers
  • Active myofascial trigger points in the upper trapezius and neck

排除标准

  • Fibromyalgia
  • Discal Hernia
  • Radiculopathy, Myelopathy
  • Having received trigger point injection and physical therapy within the last 1 month
  • Neck or Back surgery
  • Rheumatismal diseases
  • Pregnancy

结局指标

主要结局

Visual Analog Scale (VAS) Score Change

时间窗: baseline, pre-intervention and 24 hours after the last intervention

The VAS is a tool used to help a person rate the intensity of certain sensations and feelings. This Outcome Measure will assess pain. This VAS is a straight horizontal line of fixed length from 0 to 10 cm with 0 cm indicating no pain and 10 cm indicating the worst pain imaginable.

Pain Pressure Threshold (PPT) Score Change

时间窗: baseline, pre-intervention and 24 hours after the last intervention

PPT is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom. Higher scores mean better outcome.

次要结局

  • Neck Disability Index (NDI) Score Change(baseline, pre-intervention and 24 hours after the last intervention)
  • Cervical Range of Motion (cROM) Change(baseline, pre-intervention and 24 hours after the last intervention)
  • Short Form - 36 (SF-36) Score Change(baseline, pre-intervention and 24 hours after the last intervention)

研究者

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

Sergen Devran

Principal Investigator, Sports Medicine Residency, Medical Doctor

Istanbul University

研究点 (2)

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