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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03056131
Other study ID # PI15/0229
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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