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临床试验/NCT03056131
NCT03056131已完成不适用

Diacutaneous Fibrolysis, Effects on Tension Type Headache

Sara Cabanillas Barea0 个研究点目标入组 82 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
主要终点
Change in Pain Intensity

研究概览

简要总结

Tension Type Headache (TTH) is a frecuent type of headache disorder (about 1 person in 5 worldwide). Individuals with TTH typically present pericraneal tenderness and an increased cervical muscle tone.

The most common treatment in primary care consists mainly on analgesic medication. However, different techniques of manual therapy have been shown to be effective in the treatment of these patients. Diacutaneous fibrolysis shows clinical benefits in relieving symptoms of tension type headache, but there is no scientific evidence that analyzes this effects.

The hypothesis of this study was that adding treatment with diacutaneous fibrolysis to the usual conservative treatment has beneficial effects on different variables of the headache.

The aim of the study was to assess the effect of diacutaneous fibrolisis on intensity, frequency, duration of headache and cervical function in patients with tension type headache.

A randomized controlled clinical trial has been designed to evaluate the effectiveness of diacutaneous fibrolysis technique compared to usual general practicioner care in patientes with tension type headache.

The study protocol has been approved by the Clinical Research Ethics Committee from the Aragon Community and all patients provided written consent.

Eighty-two people with clinical diagnosis of TTH were randomized into a intervention group or a control group. Intervention group received three sessions of Diacutaneous Fibrolysis, while control group was advised to maintain their usual pharmacologic treatment. Pain intensity (VAS), frecuency, location, cervical range of motion, head forward position and pressure pain thresholds (PPTs) were measured at baseline, postintervention, and 1 month follow-up after treatment. The Spanish version of the HIT-6 Questionnaire was used to measure disability/function at baseline and 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 (Outcomes Assessor)

入排标准

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

入选标准

  • Diagnosis of Tension-Type Headache according to the criteria of ICDH-III.

排除标准

  • Currently undergoing physiotherapy treatment for headache
  • Modification of pharmacological treatment in the last month
  • Presence of red flags

研究组 & 干预措施

Diacutaneous Fibrolysis Treatment

Experimental

干预措施: Diacutaneous Fibrolysis (Device)

Control Group

No Intervention

结局指标

主要结局

Change in Pain Intensity

时间窗: 10 days

Visual Analog Scale (VAS)

次要结局

  • Dissability(1 month)
  • Change in Pain Frequency(10 days)
  • Pericraneal tenderness(10 days)
  • Cervical Range of motion(10 days)
  • Pressure Pain Threshold(10 days)

研究者

发起方
Sara Cabanillas Barea
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sara Cabanillas Barea

PT

Universidad de Zaragoza

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