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Diacutaneous Fibrolysis, Effects on Tension Type Headache

Diacutaneous Fibrolysis, Effects on Tension Type Headache

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03056131
Enrollment
82
Registered
2017-02-17
Start date
2015-10-31
Completion date
2018-05-31
Last updated
2018-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tension-Type Headache

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.

Interventions

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

Sponsors

Sara Cabanillas Barea
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Intensity10 daysVisual Analog Scale (VAS)

Secondary

MeasureTime frameDescription
Change in Pain Frequency10 days
Pressure Pain Threshold10 daysPressure algometry
Pericraneal tenderness10 daysManual assessment
Cervical Range of motion10 daysCervical Range of Motion (CROM)
Dissability1 monthHIT-6 Questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026