Tension-Type HeadacheNCT03056131
Diacutaneous Fibrolysis, Effects on Tension Type Headache
A study testing Diacutaneous Fibrolysis in people with Tension-Type Headache, run by Sara Cabanillas Barea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Diacutaneous Fibrolysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Tension-Type Headache according to the criteria of ICDH-III.
Who cannot join
- Currently undergoing physiotherapy treatment for headache
- Modification of pharmacological treatment in the last month
- Presence of red flags
About this study
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.
Read more
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.
- Conditions
- Tension-Type Headache
- Being tested
- Diacutaneous Fibrolysis
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Diacutaneous Fibrolysis Treatment | Experimental | Not described Receives: Device: Diacutaneous Fibrolysis |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Visual Analog Scale (VAS)
Measured: 10 days
Secondary outcomes (5)
Change in Pain Frequency
Measured: 10 days
Pressure Pain Threshold
Pressure algometry
Measured: 10 days
Pericraneal tenderness
Manual assessment
Measured: 10 days
Cervical Range of motion
Cervical Range of Motion (CROM)
Measured: 10 days
Dissability
HIT-6 Questionnaire
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study startOct 2015
- Primary completionDec 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Cabanillas Barea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Cabanillas Barea, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056131
- Sponsor's protocol ID
- PI15/0229
- Status last verified
- May 2018
- First submitted
- 13 Feb 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36972231
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diacutaneous Fibrolysis, Effects on Tension Type Headache
- ClinicalTrials.gov ID
- NCT03056131
- Acronym / sponsor ID
- PI15/0229
- Conditions
- Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Sara Cabanillas BareaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diacutaneous Fibrolysis Treatment | Experimental | Device: Diacutaneous Fibrolysis |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Tension-Type Headache according to the criteria of ICDH-III.
Key exclusion criteria (3 listed)
- Currently undergoing physiotherapy treatment for headache
- Modification of pharmacological treatment in the last month
- Presence of red flags
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diacutaneous FibrolysisDiacutaneous 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 | Device | Diacutaneous Fibrolysis Treatment |
Primary outcome
Change in Pain Intensity
Time frame: 10 days
Visual Analog Scale (VAS)
5 secondary outcomes
Change in Pain Frequency
Time frame: 10 days
Pressure Pain Threshold
Time frame: 10 days
Pericraneal tenderness
Time frame: 10 days
Cervical Range of motion
Time frame: 10 days
Dissability
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 36972231Cabanillas-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Diacutaneous Fibrolysis in people with Tension-Type Headache, run by Sara Cabanillas Barea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03056131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.