Tension-Type HeadacheNCT06108180
Effectiveness of the Dry Needling Approach in Patients With Tension-Type Headache
A study testing Dry Needling in people with Tension-Type Headache and Dry Needling, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Randomized Single-Blind Clinical Trial in which the treatment will be administered through 3 sessions of dry needling in the cervical, cranial, and facial musculature in patients with frequent and chronic tension-type headache. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tension-Type Headache, Dry Needling
- What is being tested?
- Dry Needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 23 Oct 2023to 5 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of tension headache according to IHS
Who cannot join
- Documented major trauma through medical history in the cervical area and/or recent surgery.
- Pregnancy.
- Generalized pain.
- Inflammatory, hormonal, or neurological disorders.
- Tendon disorders in the upper extremities.
- Severe psychiatric illnesses.
Show all 10Show fewer
- Inability to complete the form in Spanish.
- Having a pacemaker (due to the use of equipment with magnetic sensors).
- Specific contraindications to invasive or conservative physiotherapy (infection, fever, hypothyroidism, wounds in the puncture area, metal allergies, cancer, systemic diseases, or belonephobia).
- Having received physiotherapy treatment for the condition in the past month.
Trial locations and contacts
1 site in 1 country.
About this study
Randomized Single-Blind Clinical Trial in which the treatment will be administered through 3 sessions of dry needling in the cervical, cranial, and facial musculature in patients with frequent and chronic tension-type headache.
- Conditions
- Tension-Type Headache, Dry Needling
- Being tested
- Dry Needling
- 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.
Dry NeedlingOther
3 treatment to eliminate active trigger points that patients have
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling group | Experimental | Not described Receives: Other: Dry Needling |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active trigger points
The investigators assess the sensitivity of trigger points using algometry to determine which points reproduce the participants tensional-type headache.
Measured: 1 month
Secondary outcomes (1)
cervical ROM
general cervical range of movement, upper and lower cervical
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 posted30 Oct 2023
- Study start23 Oct 2023
- Primary completion17 Nov 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofía Monti Ballano, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108180
- Sponsor's protocol ID
- RAT 2023-195
- Status last verified
- May 2024
- First submitted
- 20 Oct 2023
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrante T, Manzoni GC, Russo M, Camarda C, Taga A, Veronesi L, Pasquarella C, Sansebastiano G, Torelli P. Prevalence of tension-type headache in adult general population: the PACE study and review of the literature. Neurol Sci. 2013 May;34 Suppl 1:S137-8. doi: 10.1007/s10072-013-1370-4.
PubMed 23695063Fernandez-de-Las-Penas C, Ge HY, Arendt-Nielsen L, Cuadrado ML, Pareja JA. The local and referred pain from myofascial trigger points in the temporalis muscle contributes to pain profile in chronic tension-type headache. Clin J Pain. 2007 Nov-Dec;23(9):786-92. doi: 10.1097/AJP.0b013e318153496a.
PubMed 18075406Cerezo-Tellez E, Torres-Lacomba M, Fuentes-Gallardo I, Perez-Munoz M, Mayoral-Del-Moral O, Lluch-Girbes E, Prieto-Valiente L, Falla D. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial. Pain. 2016 Sep;157(9):1905-1917. doi: 10.1097/j.pain.0000000000000591.
PubMed 27537209Stephens LR, Humphrey JD, Little PB, Barnum DA. Morphological, biochemical, antigenic, and cytochemical relationships among Haemophilus somnus, Haemophilus agni, Haemophilus haemoglobinophilus, Histophilus ovis, and Actinobacillus seminis. J Clin Microbiol. 1983 May;17(5):728-37. doi: 10.1128/jcm.17.5.728-737.1983.
PubMed 6408118
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Dry Needling Approach in Patients With Tension-Type Headache
- ClinicalTrials.gov ID
- NCT06108180
- Acronym / sponsor ID
- RAT 2023-195
- Conditions
- Tension-Type Headache, Dry Needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 30 Oct 2023 (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.
Randomized Single-Blind Clinical Trial in which the treatment will be administered through 3 sessions of dry needling in the cervical, cranial, and facial musculature in patients with frequent and chronic tension-type headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling group | Experimental | Other: Dry Needling |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a diagnosis of tension headache according to IHS
Key exclusion criteria (10 listed)
- Documented major trauma through medical history in the cervical area and/or recent surgery.
- Pregnancy.
- Generalized pain.
- Inflammatory, hormonal, or neurological disorders.
- Tendon disorders in the upper extremities.
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 |
|---|---|---|
| Dry Needling3 treatment to eliminate active trigger points that patients have | Other | Dry Needling group |
Primary outcome
Active trigger points
Time frame: 1 month
The investigators assess the sensitivity of trigger points using algometry to determine which points reproduce the participants tensional-type headache.
1 secondary outcome
cervical ROM
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 14 May 2024.
- Background: PubMed 23695063Ferrante T, Manzoni GC, Russo M, Camarda C, Taga A, Veronesi L, Pasquarella C, Sansebastiano G, Torelli P. Prevalence of tension-type headache in adult general population: the PACE study and review of the literature. Neurol Sci. 2013 May;34 Suppl 1:S137-8. doi: 10.1007/s10072-013-1370-4.
- Background: PubMed 18075406Fernandez-de-Las-Penas C, Ge HY, Arendt-Nielsen L, Cuadrado ML, Pareja JA. The local and referred pain from myofascial trigger points in the temporalis muscle contributes to pain profile in chronic tension-type headache. Clin J Pain. 2007 Nov-Dec;23(9):786-92. doi: 10.1097/AJP.0b013e318153496a.
- Background: PubMed 27537209Cerezo-Tellez E, Torres-Lacomba M, Fuentes-Gallardo I, Perez-Munoz M, Mayoral-Del-Moral O, Lluch-Girbes E, Prieto-Valiente L, Falla D. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial. Pain. 2016 Sep;157(9):1905-1917. doi: 10.1097/j.pain.0000000000000591.
- Background: PubMed 6408118Stephens LR, Humphrey JD, Little PB, Barnum DA. Morphological, biochemical, antigenic, and cytochemical relationships among Haemophilus somnus, Haemophilus agni, Haemophilus haemoglobinophilus, Histophilus ovis, and Actinobacillus seminis. J Clin Microbiol. 1983 May;17(5):728-37. doi: 10.1128/jcm.17.5.728-737.1983.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling in people with Tension-Type Headache and Dry Needling, run by Universidad de Zaragoza at 1 site in Spain.
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 10 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Active trigger points (time frame: 1 month). 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 NCT06108180, which also lists 4 linked publications.
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 14 May 2024.