Diacutaneous Fibrolysis, Effects on Tension Type Headache

NCT ID: NCT03056131

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tension-Type Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diacutaneous Fibrolysis Treatment

Group Type EXPERIMENTAL

Diacutaneous Fibrolysis

Intervention Type DEVICE

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

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sara Cabanillas Barea

OTHER

Sponsor Role lead

Responsible Party

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Sara Cabanillas Barea

PT

Responsibility Role SPONSOR_INVESTIGATOR

References

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Cabanillas-Barea S, Perez-Guillen S, Lopez-de-Celis C, Rodriguez-Sanz J, Fanlo-Mazas P, Carrasco-Uribarren A. Effects of diacutaneous fibrolysis in patients with tension-type headache: A randomized controlled trial. PLoS One. 2023 Mar 27;18(3):e0273877. doi: 10.1371/journal.pone.0273877. eCollection 2023.

Reference Type DERIVED
PMID: 36972231 (View on PubMed)

Other Identifiers

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PI15/0229

Identifier Type: -

Identifier Source: org_study_id

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