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

NCT ID: NCT03591601

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2018-12-15

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

Conditions

Tension-type Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Manual therapy protocol

Treatment based on manual therapy with proven evidence.

Group Type: ACTIVE_COMPARATOR

Manual Therapy protocol

Intervention Type: OTHER

Treatment based on manual therapy with proven evidence.

Foam Rolling protocol

Treatment based on massage with a Foam Rolling

Group Type: EXPERIMENTAL

Foam Rolling protocol

Intervention Type: OTHER

Treatment based on massage with a Foam Rolling

Placebo Control

Placebo treatment based on the placement of the hands on the head without intention to treat.

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: OTHER

Placebo treatment based on the placement of the hands on the head without intention to treat.

Interventions

Manual Therapy protocol

Treatment based on manual therapy with proven evidence.

Intervention Type: OTHER

Foam Rolling protocol

Treatment based on massage with a Foam Rolling

Intervention Type: OTHER

Placebo control

Placebo treatment based on the placement of the hands on the head without intention to treat.

Intervention Type: OTHER

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.
• Accompanied by some associated symptom:

or Photophobia. or Fonofobia. or mild nausea.

Exclusion Criteria

• Have less than 20 years or more than 55.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

GEMMA V ESPÍ LÓPEZ, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physiotherapy

Valencia, , Spain

Gemma V Espí López

Valencia, , Spain

Countries

Spain

Other Identifiers

ID0021

Identifier Type: -

Identifier Source: org_study_id