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临床试验/NCT04185714
NCT04185714已完成不适用

THE EFFECTS OF KINESIO®TAPING ON PAIN, DISABILITY AND QUALITY OF LIFE IN PATIENTS WITH MIGRAINE: A RANDOMISED SINGLE-BLIND, PLACEBO-CONTROLLED TRIAL

Medipol University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Baseline Dolorimeter

研究概览

简要总结

In patients with migraine, neck pain and trigger points in the neck muscles are common in clinical practice. This study was to investigate whether kinesiotaping applied to the cervical muscles has a clinical effect on pressure pain threshold, disability and quality of life in patients with migraine.

详细描述

Patients with episodic migraine who were followed up by department of neurology in regional hospital will be included in the study. The Clinical Research Ethics committee approved the study (protocol no 10840098-604.01.1-E.6803).

Inclusion criterias are aged between 18-55 years, the patients with episodic migraine by neurologist according to ICHD-3 Beta criteria, patients with episodic migraine and associated neck pain, headache frequency in 1 month < 15 days and pain severity according to VAS above 40 mm.

Exclusion criterias are other headache types, contraindication for KT technique, cervical disc disorders, systemic rheumatic disease, fibromyalgia pain syndrome, myofascial pain syndrome, temporamandibular joint dysfunction, pregnancy, overuse medication, patients who had gotten rehabilitation programme before at least 3 months ago and anaesthetic blockage before at least 6 months ago.

All patients will allocate three groups. The patients with episodic migraine were randomly assigned to control group (n=20), placebo group (n=20) and experimental group (n= 20).

Outcome measures Demographic data and headache characteristics of the patients (frequency, duration, onset of headache, family history, onset age of headache, pain triggering factors, and localization of headache), presence of neck pain and disability of the last 1 month will evaluate before and after 6 weeks of treatment via self-administered questionnaire. Pressure Pain Algometry (Baseline Dolorimeter), Visual Analogue Scale (VAS), Neck Disability Index, Migraine Disability Assessment Scale (MIDAS) and Short Form-36 (SF-36) will use as the assessment method in the 6-week follow-up.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria
  • age between 18-55 years,
  • the patients with episodic migraine by neurologist according to ICHD-3 Beta criteria,
  • headache frequency in 1 month < 15 days and
  • pain severity according to VAS above 40 mm.

排除标准

  • other headache disorders
  • disc disorders,
  • systemic rheumatic disease, fibromyalgia pain syndrome, myofascial pain syndrome,
  • temporamandibular joint dysfunction,
  • pregnancy,
  • overuse medication,
  • patients who had gotten rehabilitation programme before at least 3 months ago and
  • anaesthetic blockage before at least 6 months ago.

结局指标

主要结局

Baseline Dolorimeter

时间窗: pretreatment- Posttreatment ( 6 weeks later)

pressure pain threshold

Clinical data questionnaire

时间窗: pretreatment- Posttreatment ( 6 weeks later)

clinical data

visual analog scale

时间窗: Pretreatment-Posttreatment (6 weeks later)

Neck pain severity

次要结局

  • Short form-36(pretreatment - Post treatment (6 weeks later))
  • MIDAS(Pretreatment)
  • Neck Disability Index(pretreatment - Post treatment (6 weeks later))

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Kınacı

Research Asistant

Medipol University

研究点 (1)

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