Diacutaneous Fibrolysis, Effects on Tension Type Headache

Study Overview
=================
Brief 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.

Official Title
-----------------
Diacutaneous Fibrolysis, Effects on Tension Type Headache

Conditions
-----------------
Tension-Type Headache

Intervention / Treatment
-----------------
* Device: Diacutaneous Fibrolysis


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diacutaneous Fibrolysis Treatment<br> | Device: Diacutaneous Fibrolysis<br>* 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<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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