Diacutaneous Fibrolysis, Effects on Tension Type Headache

May 1, 2018 updated by: Sara Cabanillas Barea

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: Diacutaneous Fibrolysis Treatment
Device: Diacutaneous Fibrolysis
Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means a set of metallic hooks having the advantage of allowing a deeper and more precise application, which could not be achieved manually

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity
Time Frame: 10 days
Visual Analog Scale (VAS)
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Frequency
Time Frame: 10 days
10 days
Pressure Pain Threshold
Time Frame: 10 days
Pressure algometry
10 days
Pericraneal tenderness
Time Frame: 10 days
Manual assessment
10 days
Cervical Range of motion
Time Frame: 10 days
Cervical Range of Motion (CROM)
10 days
Dissability
Time Frame: 1 month
HIT-6 Questionnaire
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sara Cabanillas Barea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 17, 2017

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI15/0229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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