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
About this trial
This is an interventional treatment trial for Tension-Type Headache
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
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
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
Learn more about this trial
Diacutaneous Fibrolysis, Effects on Tension Type Headache
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