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临床试验/NCT05622487
NCT05622487已完成不适用

The Effects of Neural Therapy and Kinesio Taping on Pain, Functional Status, and Quality of Life in Fibromyalgia Patients: A Prospective Randomized Double-Blind Study

Istanbul University4 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2021年3月1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
65
试验地点
4
主要终点
Visual Analogue Scale pain (0-10 point).

研究概览

简要总结

The aim of this study; to investigate the effects of neural therapy and kinesio taping treatments on pain, functional status and quality of life in women with fibromyalgia.

详细描述

Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep disturbance, cognitive impairment, and other physical symptoms that negatively affect physical and sensory functions and impair quality of life. Neural therapy and kinesio taping are treatments for musculoskeletal diseases. In this prospective, randomized controlled, double-blind, interventional study, 64 patients aged 18-55 years who met the eligibility criteria will be included in the study. Eligible participants will be randomly assigned to one of two groups using computer generated random numbers. Segmental neural therapy and sham kinesio taping will be applied to the first group. In the second group, kinesio taping with inhibition technique will be applied to bilateral trapezius and erector spina muscles and sham neural therapy will be added. Treatments will be applied once a week for a total of 6 weeks. Both groups will be given a home exercise program consisting of stretching exercises and will be checked every week. During the follow-up period, patients will be asked not to make changes to their current medical treatment. Participants will be evaluated for pain by Visual Analogue Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Central Sensitisation Inventory (CSI), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Health Assessment Questionnaire (HAQ), Short Form-36 (SF-36), manual algometer measurements and number of tender points, as well as post-treatment and post-treatment 3 month control data.

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 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • To be diagnosed with fibromyalgia according to the ACR 2016 diagnostic criteria.
  • Being a woman between the ages of 18 and
  • No change in the medical treatment he received for fibromyalgia syndrome during the study
  • To be able to come to treatment 1 day a week for 6 weeks

排除标准

  • Presence of known central nervous system or peripheral nervous system disease, progressive neurological deficit
  • Peripheral venous insufficiency, coagulopathies and anticoagulant drug use
  • Loss of sensation, loss of position sense, unhealed fracture or open surgical wound
  • Uncontrolled hypertension and uncontrolled diabetes
  • Be in major depression
  • Cognitive impairment that causes difficulty following simple commands
  • Pregnancy
  • Be in menopause
  • Allergy to local anesthetics and kinesio taping
  • Open wound or infection at the application site

结局指标

主要结局

Visual Analogue Scale pain (0-10 point).

时间窗: up to 3 month

Higher scores mean a worse outcome

Pain measurement with manual algometer

时间窗: up to 3 month

18 tender points in 1990 ACR FMS criteria will be evaluated with a manual algometer. Higher scores mean a worse outcome

Fibromyalgia Impact Questionnaire (0-100 point)

时间窗: up to 3 month

The Fibromyalgia Impact Questionnaire was developed to assess the current functional status of women with FMS. Higher scores mean a worse outcome

次要结局

  • Beck Depression Inventory (0-63 point)(up to 3 month)
  • Central Sensitisation Inventory (0-100 point)(up to 3 month)
  • Beck Anxiety Inventory (0-63 point)(up to 3 month)
  • Health Assessment Questionnaire (0-60 point)(up to 3 month)
  • Short Form-36 (0-100 point)(up to 3 month)

研究者

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

Sinan GOK

Principal Investigator

Istanbul University

研究点 (4)

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