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临床试验/NCT03591601
NCT03591601已完成不适用

Effectiveness of a Global Manual Therapy Protocol vs Exercises With Foam Rolling for Tension Headache

University of Valencia4 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年8月15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
38
试验地点
4
主要终点
Intensity of pain

研究概览

简要总结

Tension headache (CT) is the most frequent problem within the group of headaches, with a prevalence of 30-78% of the population throughout its life. Regarding this pathology, treatment with manual therapy has been studied a lot, observing the benefits of different techniques separately in elements such as disability, impact or depression.

The "Foam Rolling" (FR) is an element widely used in sport that has been studied its applications in terms of hip and knee flexibility after application in muscles such as the quadriceps or hamstrings.

In this study the investigators recruited randomized subjects in three groups, one of exercises with RF, another of a protocol of manual therapy (TM) techniques and one control (CTR) with a placebo treatment. There will be 4 treatments, 1 per week, and the data will be collected in 3 moments, pre-treatment, post-treatment and one month after treatment.

The investigators will evaluate aspects such as the average pain of headaches, the impact, disability, quality of life, self-satisfaction and pain at the pressure of painful points of the trapezius and suboccipital muscles.

详细描述

Introduction Primary headaches occupy an important field in neurology consultations. Both migraines and tension headaches are often self-treated by the patients themselves and for some patients, headache is a true disease, constituting a symptomatology that can have various etiologies, from severe to functional organics. Headache, when it becomes chronic, becomes a serious problem for the patient with important repercussions on their quality of life.

Objective. To evaluate the effectiveness of the application of the treatment by means of manual therapy in patients with tension headache and to compare it with the application of massage by means of a roll of foam manufactured for this purpose.

Methodology The study will be carried out in the Faculty of Physiotherapy of the Universitat de València. An experimental, longitudinal and prospective design, controlled, randomized, with 3 groups will be carried out.

Population. The sample will be formed by participants diagnosed with tension headache, following the criteria established by the IHS.

Subjects with headache less than 15 days per month and other types of primary headache, as well as those associated with drug abuse and those who do not meet the criteria established by the IHS, will be excluded from the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Double (Participant, Investigator)

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

  • Be between 20 and 55 years old.
  • CT medical diagnosis.
  • Evolution of, at least, 3 months of the CT.
  • Suffer, at least, 1 crisis a week.
  • Meet, at least, 2 of the following IHS criteria:
  • Bilateral location.
  • Pressure pain, not pulsating pain.
  • Having a mild-moderate pain intensity.
  • Pain that is not aggravated by physical activity.
  • Minimum duration of 30 'of the TC.
  • Accompanied by some associated symptom:
  • or Photophobia. or Fonofobia. or mild nausea.

排除标准

  • Have less than 20 years or more than
  • Cervical trauma.
  • Musculoskeletal problems that may be aggravated by movement.
  • Klein test positive.
  • Contraindications to receive manual therapy.
  • Musculoskeletal problems that may give another type of headache.
  • Problems of dizziness.

结局指标

主要结局

Intensity of pain

时间窗: 8 weeks

Visual Analog Scale. The participants are asked to mark the intensity of pain from 1 to 10, with 1 being almost non-existent and 10 being the worst pain imaginable.

次要结局

  • Impact of headache(8 weeks)
  • Disability headache(8 weeks)
  • Health Status(8 weeks)
  • Pressure pain threshold(8 weeks)
  • Cervical range movment(8 weeks)
  • Body satisfaction(8 weeks)

研究者

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

GEMMA V ESPÍ LÓPEZ, PhD

Principal Investigator

University of Valencia

研究点 (4)

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