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Diacutaneous Fibrolysis, Effects on Tension Type Headache

Primary Purpose

Tension-Type Headache

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diacutaneous Fibrolysis
Sponsored by
Sara Cabanillas Barea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Diacutaneous Fibrolysis Treatment

    Control Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Pain Intensity
    Visual Analog Scale (VAS)

    Secondary Outcome Measures

    Change in Pain Frequency
    Pressure Pain Threshold
    Pressure algometry
    Pericraneal tenderness
    Manual assessment
    Cervical Range of motion
    Cervical Range of Motion (CROM)
    Dissability
    HIT-6 Questionnaire

    Full Information

    First Posted
    February 13, 2017
    Last Updated
    May 1, 2018
    Sponsor
    Sara Cabanillas Barea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03056131
    Brief Title
    Diacutaneous Fibrolysis, Effects on Tension Type Headache
    Official Title
    Diacutaneous Fibrolysis, Effects on Tension Type Headache
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    May 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Sara Cabanillas Barea

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tension-Type Headache

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diacutaneous Fibrolysis Treatment
    Arm Type
    Experimental
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Diacutaneous Fibrolysis
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change in Pain Intensity
    Description
    Visual Analog Scale (VAS)
    Time Frame
    10 days
    Secondary Outcome Measure Information:
    Title
    Change in Pain Frequency
    Time Frame
    10 days
    Title
    Pressure Pain Threshold
    Description
    Pressure algometry
    Time Frame
    10 days
    Title
    Pericraneal tenderness
    Description
    Manual assessment
    Time Frame
    10 days
    Title
    Cervical Range of motion
    Description
    Cervical Range of Motion (CROM)
    Time Frame
    10 days
    Title
    Dissability
    Description
    HIT-6 Questionnaire
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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