Diacutaneous Fibrolysis, Effects on Tension Type Headache

Tension-Type Headache Clinical Trial

Official title:

Diacutaneous Fibrolysis, Effects on Tension Type Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056131
• Other study ID #: PI15/0229
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sara Cabanillas Barea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Intensity	Visual Analog Scale (VAS)	10 days
Secondary	Change in Pain Frequency		10 days
Secondary	Pressure Pain Threshold	Pressure algometry	10 days
Secondary	Pericraneal tenderness	Manual assessment	10 days
Secondary	Cervical Range of motion	Cervical Range of Motion (CROM)	10 days
Secondary	Dissability	HIT-6 Questionnaire	1 month