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Diacutaneous Fibrolysis, Effects on Tension Type Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03056131
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : May 2, 2018
Information provided by (Responsible Party):
Sara Cabanillas Barea, Universidad de Zaragoza

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.

Condition or disease Intervention/treatment Phase
Tension-Type Headache Device: Diacutaneous Fibrolysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in Pain Intensity [ Time Frame: 10 days ]
    Visual Analog Scale (VAS)

Secondary Outcome Measures :
  1. Change in Pain Frequency [ Time Frame: 10 days ]
  2. Pressure Pain Threshold [ Time Frame: 10 days ]
    Pressure algometry

  3. Pericraneal tenderness [ Time Frame: 10 days ]
    Manual assessment

  4. Cervical Range of motion [ Time Frame: 10 days ]
    Cervical Range of Motion (CROM)

  5. Dissability [ Time Frame: 1 month ]
    HIT-6 Questionnaire

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Sara Cabanillas Barea, PT, Universidad de Zaragoza Identifier: NCT03056131    
Other Study ID Numbers: PI15/0229
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tension-Type Headache
Neurologic Manifestations
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases