NCT03056131

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

February 13, 2017

Last Update Submit

May 1, 2018

Conditions

Tension-Type Headache

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity

    Visual Analog Scale (VAS)

    10 days

Secondary Outcomes (5)

  • Change in Pain Frequency

    10 days

  • Pressure Pain Threshold

    10 days

  • Pericraneal tenderness

    10 days

  • Cervical Range of motion

    10 days

  • Dissability

    1 month

Study Arms (2)

Diacutaneous Fibrolysis Treatment

EXPERIMENTAL
Device: Diacutaneous Fibrolysis

Control Group

NO INTERVENTION

Interventions

Diacutaneous FibrolysisDEVICE

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

Diacutaneous Fibrolysis Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Tension-Type Headache according to the criteria of ICDH-III.

You may not qualify if:

  • Currently undergoing physiotherapy treatment for headache
  • Modification of pharmacological treatment in the last month
  • Presence of red flags

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36972231DERIVED

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PT

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 17, 2017

Study Start

October 1, 2015

Primary Completion

December 1, 2017

Study Completion

May 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share