Clinical Trials Directory

Trials / Completed

CompletedNCT03056131

Diacutaneous Fibrolysis, Effects on Tension Type Headache

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
82 (actual)
Sponsor
Sara Cabanillas Barea · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEDiacutaneous FibrolysisDiacutaneous 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

Timeline

Start date
2015-10-01
Primary completion
2017-12-01
Completion
2018-05-01
First posted
2017-02-17
Last updated
2018-05-02

Source: ClinicalTrials.gov record NCT03056131. Inclusion in this directory is not an endorsement.