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Clinical Trials/NCT03591601
NCT03591601
Completed
Not Applicable

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

University of Valencia2 sites in 1 country38 target enrollmentAugust 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tension-type Headache
Sponsor
University of Valencia
Enrollment
38
Locations
2
Primary Endpoint
Intensity of pain
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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. Experimental treatment The patients will be randomly assigned to 3 different groups (one group of treatment with manual therapy, one group that will receive massage and another group of placebo control). The treatment will last for 8 weeks (4 weeks of treatment and 4 weeks of follow-up). The 2 groups will be evaluated before treatment, at the end of this and in the follow-up (30 days after treatment). Evaluations For the collection of data, a clinical interview with data referring to headache was designed and the following evaluation instruments are included: * Scale disability due to HDI Headache * Impact of pain HIT-6 * Quality of life SF-36 * Visual Analog Scale (EVA) * Algometry. Measurement of pain at pressure on spinous and transverse processes * CROM. Cervical range * QS. Body satisfaction questionnaire

Registry
clinicaltrials.gov
Start Date
August 15, 2018
End Date
December 15, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

GEMMA V ESPÍ LÓPEZ, PhD

Principal Investigator

University of Valencia

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Intensity of pain

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (2)

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