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Clinical Trials/NCT03056131
NCT03056131CompletedNot Applicable

Diacutaneous Fibrolysis, Effects on Tension Type Headache

Sara Cabanillas Barea0 sites82 target enrollmentStarted: October 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
82
Primary Endpoint
Change in Pain Intensity

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Diacutaneous Fibrolysis Treatment

Experimental

Intervention: Diacutaneous Fibrolysis (Device)

Control Group

No Intervention

Outcomes

Primary Outcomes

Change in Pain Intensity

Time Frame: 10 days

Visual Analog Scale (VAS)

Secondary Outcomes

  • Dissability(1 month)
  • Change in Pain Frequency(10 days)
  • Pericraneal tenderness(10 days)
  • Cervical Range of motion(10 days)
  • Pressure Pain Threshold(10 days)

Investigators

Sponsor
Sara Cabanillas Barea
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Sara Cabanillas Barea

PT

Universidad de Zaragoza

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