Diacutaneous Fibrolysis, Effects on Tension Type Headache
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|ClinicalTrials.gov Identifier: NCT03056131|
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : May 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Tension-Type Headache||Device: Diacutaneous Fibrolysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Diacutaneous Fibrolysis, Effects on Tension Type Headache|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||May 2018|
|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
|No Intervention: Control Group|
- Change in Pain Intensity [ Time Frame: 10 days ]Visual Analog Scale (VAS)
- Change in Pain Frequency [ Time Frame: 10 days ]
- Pressure Pain Threshold [ Time Frame: 10 days ]Pressure algometry
- Pericraneal tenderness [ Time Frame: 10 days ]Manual assessment
- Cervical Range of motion [ Time Frame: 10 days ]Cervical Range of Motion (CROM)
- Dissability [ Time Frame: 1 month ]HIT-6 Questionnaire