Cervicogenic HeadacheNCT07794319
Osteopathic Care Combined With Physiotherapy and Pain Education for Cervicogenic Headache
A study testing Osteopathic Care and Physiotherapy in people with Cervicogenic Headache, run by Centro Universitário Augusto Motta at 1 site in Brazil.
Trial summary
Introduction: Cervicogenic headache (CH) is a secondary headache associated with non-traumatic dysfunctions of the cervical region. Osteopathic Care (OC) has shown promising results in reducing pain and disability in patients with migraine, tension-type headaches and CH, but the effectiveness of OC remains scarce, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Osteopathic Care and Physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- males and females from Rio de Janeiro - RJ - BR
- over 18 years old
- diagnostic criteria for cervicogenic headache established by the International Classification of Headache Disorders (ICHD-III)
- must report episodic headache for at least 3 months, occurring at least once per week
- present cervical mobility less than 44° on the cervical flexion-rotation test (CFRT)
- exhibit headache during provocative tests at C0, C1, C2, and/or C3
Who cannot join
- undergoing other physiotherapy, osteopathic, orthodontic, or medical treatment
- present neurological disorders
- have signs of trauma or fracture
- report symptoms of vertigo or tinnitus
- have another condition that may be the origin of the headache
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Centro Universitário Augusto Motta
Rio de Janeiro, Rio de Janeiro, 21041-020
About this study
Official title: Osteopathic Care Combined With Physiotherapy and Pain Education for Cervicogenic Headache: Study Protocol for a Three-arm Pragmatic Randomized Controlled Trial
Introduction: Cervicogenic headache (CH) is a secondary headache associated with non-traumatic dysfunctions of the cervical region. Osteopathic Care (OC) has shown promising results in reducing pain and disability in patients with migraine, tension-type headaches and CH, but the effectiveness of OC remains scarce, and the studies has low certainty of evidence. Objective: To investigate the effectiveness of the OC in the management of headache-related disability in patients with CH 6 weeks and 24 weeks after the intervention compared with sham and control group. Methods: This is a three-arm, pragmatic, randomized controlled trial. A total of 120 adult participants with chronic CH will be recruited. Participants must report episodic headache for at least 3 months, occurring at least once per week, present cervical mobility less than 44° on the cervical flexion-rotation test, and exhibit headache during provocative tests at C0, C1, C2, and/or C3. After randomization, the experimental group will receive OC plus Physiotherapy (specific exercises for the cervical spine and Mulligan´s manual therapy) and a pain education booklet. The control group will receive the same Physiotherapy and pain education intervention. The sham group will receive the OC sham combined with Physiotherapy and pain education. Primary outcome will be headache-related disability, assessed by Headache Impact Test (HIT-6). Secondary outcomes will be pain intensity (VAS) and the Perceived Changes Questionnaire (PCQ). Outcome assessment will be carried out at baseline, 6 weeks after the intervention and 24 weeks follow up with an intention-to-treat framework. Expected Results: OC combined with Physiotherapy and pain education would be effectiveness in reducing headache-related disability compared to the sham and control groups, 6 weeks after the intervention.
- Conditions
- Cervicogenic Headache
- Being tested
- Osteopathic Care, Physiotherapy, Sham (No Treatment)
- Keywords
- Cervicogenic Headache, Secondary Headache Disorders, Musculoskeletal Manipulations, Osteopathic Manipulation, Osteopathic Medicine
- Medical subject headings
- Post-Traumatic Headache, Headache Disorders, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic CareOther
Participants will receive OC targeting segments affected by somatic dysfunctions to restore function. All individual treatments will be documented in a table detailing the osteopathic technique applied for each identified somatic dysfunction, including musculoskeletal, visceral, and cranial approaches. Each intervention session will last between 30 and 45 minutes. In addition to OC, participants will also receive the same physiotherapy program and pain education booklet as the control group. In the present study, we will not use drugs or devices.
PhysiotherapyOther
Participants will be managed by a licensed physiotherapist with over 10 years of experience. They will undergo a physiotherapy program and receive a pain education booklet. The physiotherapy program consists of specific motor control exercises for the neck and Mulligan Concept manual therapy techniques. In the present study, we will not use drugs or devices.
Sham (No Treatment)Other
Participants will receive sham OC, consisting of light touch, movement arc maneuvers, and simulated osteopathic manipulation, in which the patient is positioned but the final manipulative thrust is not performed. In addition to sham OC, participants will also receive the same physiotherapy program and pain education booklet as the control group. In the present study, we will not use drugs or devices.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Care | Experimental | The participants in the Experimental Group will receive Osteopathic Care (OC) targeting segments affected by somatic dysfunctions to restore function. All individual treatments will be documented in a table detailing the osteopathic technique applied for each identified somatic dysfunction, including musculoskeletal, visceral, and cranial approaches. Each intervention session will last between 30 and 45 minutes. In addition to OC, participants will also receive the same physiotherapy program and pain education booklet as the control group. In the present study, we will not use drugs or devices. Receives: Other: Osteopathic Care |
| Sham Osteopathic Care | Sham comparator | The participants in the Sham Osteopathic Care (OC) Group will receive sham OC, consisting of light touch, movement arc maneuvers, and simulated osteopathic manipulation, in which the patient is positioned but the final manipulative thrust is not performed. In addition to sham OC, participants will also receive the same physiotherapy program and pain education booklet as the control group. In the present study, we will not use drugs or devices. Receives: Other: Sham (No Treatment) |
| Physiotherapy | Active comparator | The participants in the Control Group will be managed by a licensed physiotherapist with over 10 years of experience. They will undergo a physiotherapy program and receive a pain education booklet. The physiotherapy program consists of specific motor control exercises for the neck and Mulligan Concept manual therapy techniques. In the present study, we will not use drugs or devices. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache-related Disability
The primary outcome will be headache-related disability, measured by Headache Impact Test (HIT-6; score range: 36-78). The HIT-6 consists of six questions assessing the impact of headache on daily, physical, social, and work-related activities. Higher scores represent a greater impact. Scores above 60 indicate a very severe impact; scores between 56 and 59 indicate substantial impact; scores between 50 and 55 indicate some impact; and scores below 49 indicate little to no impact.
Measured: at baseline and at 6 weeks post-intervention
Secondary outcomes (2)
Pain Intensity
The Pain Intensity will be measured using the visual analog scale (VAS). The visual analog scale (VAS) for pain ranges from 0 to 10, where higher scores represent a greater Pain Intensity. Scores between 0-2 indicates mild pain, 3-7 moderate pain, and 8-10 severe pain. Participants will be asked to mark a point on the scale corresponding to their Pain Intensity.
Measured: at baseline, at 6 weeks post-intervention and 24 weeks post-intervention.
Perceived Change
Secondary outcomes will include Scores on the Perceived Change Scale. The Perceived Change Scale consists of 19 items assessing the patient's qualitative perception of changes in their life because of the treatment received. Each item has three response options: 1: worse than before; 2: no change; and 3: better than before. Higher scores indicate a better and more positive perception of improvement from the intervention.
Measured: at 6 weeks post-intervention and 24 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic 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
- Model description
- This is a pragmatic, three-arm, parallel-group, randomized controlled trial with blinded statistical analysis. The study will consist of 6 weeks of intervention followed by 24 weeks of follow-up, totaling 30 weeks
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Brasileiro de Osteopatia
- Responsible party
- Principal investigator, Paula Oliveira Esteves, Centro Universitário Augusto Motta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794319
- Sponsor's protocol ID
- 96290426.2.0000.5235
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers involved in the study will have access to the final clinical trial dataset and may share it for verification and publication purposes upon reasonable request. The principal investigator will be responsible for data management and will ensure that all study data are stored in both physical and digital formats for 5 years after study completion. The data entry spreadsheet will be updated by the investigator based on collected assessment forms. Study data will be entered into a password-protected database, with access restricted to authorized study personnel. Data quality will be ensured through double-checking of entries and periodic audits. All participant data will be de-identified prior to analysis to ensure confidentiality.
Publications
Olesen J. International Classification of Headache Disorders. Lancet Neurol. 2018 May;17(5):396-397. doi: 10.1016/S1474-4422(18)30085-1. Epub 2018 Mar 14. No abstract available.
PubMed 29550365Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
PubMed 6226917Reis F, Palermo TM, Acalantis L, Nogueira LC, Meziat-Filho N, Louw A, Ickmans K. "A journey to learn about pain": the development and validation of a comic book about pain neuroscience education for children. Braz J Phys Ther. 2022 Jan-Feb;26(1):100348. doi: 10.1016/j.bjpt.2021.04.009. Epub 2021 May 2.
PubMed 34001422Hage R, Demoulin C, J Puentedura E, Brismee JM. Sham treatment? Should it be redefined for its use in manual therapy clinical studies? J Man Manip Ther. 2025 Feb;33(1):1-3. doi: 10.1080/10669817.2025.2448921. Epub 2025 Jan 9. No abstract available.
PubMed 39785123Hohenschurz-Schmidt D, Draper-Rodi J, Vase L, Scott W, McGregor A, Soliman N, MacMillan A, Olivier A, Cherian CA, Corcoran D, Abbey H, Freigang S, Chan J, Phalip J, Norgaard Sorensen L, Delafin M, Baptista M, Medforth NR, Ruffini N, Skott Andresen S, Ytier S, Ali D, Hobday H, Santosa AANAA, Vollert J, Rice ASC. Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods. Pain. 2023 Mar 1;164(3):469-484. doi: 10.1097/j.pain.0000000000002723. Epub 2022 Jul 11.
PubMed 36265391Hohenschurz-Schmidt D, Vase L, Draper-Rodi J. From placebos and shams to high-quality control interventions in manual therapy trials to study efficacy and mechanisms. J Man Manip Ther. 2025 Oct;33(5):376-377. doi: 10.1080/10669817.2025.2471477. Epub 2025 Feb 22. No abstract available.
PubMed 39986688Pradela J, Bevilaqua-Grossi D, Chaves TC, Dach F, Ferreira Carvalho G. Brazilian Portuguese version of the Headache Disability Inventory: Cross-cultural adaptation, validity, and reliability. Cephalalgia. 2021 Feb;41(2):156-165. doi: 10.1177/0333102420949860. Epub 2020 Aug 20.
PubMed 32819150de Lira MR, Meziat-Filho N, Zuelli Martins Silva G, Castro J, Fernandez J, Guirro RRJ, Berg R, Chaves TC. Efficacy of cognitive functional therapy for pain intensity and disability in patients with non-specific chronic low back pain: a randomised sham-controlled trial. Br J Sports Med. 2025 Jun 18;59(13):912-920. doi: 10.1136/bjsports-2024-109012.
PubMed 40049758
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Care Combined With Physiotherapy and Pain Education for Cervicogenic Headache: Study Protocol for a Three-arm Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07794319
- Acronym / sponsor ID
- 96290426.2.0000.5235
- Conditions
- Cervicogenic Headache
- Keywords
- Cervicogenic Headache, Secondary Headache Disorders, Musculoskeletal Manipulations, Osteopathic Manipulation, Osteopathic Medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Collaborators
- Instituto Brasileiro de Osteopatia
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 31 Aug 2026 (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.
Introduction: Cervicogenic headache (CH) is a secondary headache associated with non-traumatic dysfunctions of the cervical region. Osteopathic Care (OC) has shown promising results in reducing pain and disability in patients with migraine, tension-type headaches and CH, but the effectiveness of OC remains scarce, and the studies has low certainty of evidence. Objective: To investigate the effectiveness of the OC in the management of headache-related disability in patients with CH 6 weeks and 24 weeks after the intervention compared with sham and control group. Methods: This is a three-arm, pragmatic, randomized controlled trial. A total of 120 adult participants with chronic CH will be recruited. Participants must report episodic headache for at least 3 months, occurring at least once per week, present cervical mobility less than 44° on the cervical flexion-rotation test, and exhibit headache during provocative tests at C0, C1, C2, and/or C3. After randomization, the experimental group will receive OC plus Physiotherapy (specific exercises for the cervical spine and Mulligan´s manual therapy) and a pain education booklet. The control group will receive the same Physiotherapy and pain education intervention. The sham group will receive the OC sham combined with Physiotherapy and pain education. Primary outcome will be headache-related disability, assessed by Headache Impact Test (HIT-6). Secondary outcomes will be pain intensity (VAS) and the Perceived Changes Questionnaire (PCQ). Outcome assessment will be carried out at baseline, 6 weeks after the intervention and 24 weeks follow up with an intention-to-treat framework. Expected Results: OC combined with Physiotherapy and pain education would be effectiveness in reducing headache-related disability compared to the sham and control groups, 6 weeks after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a pragmatic, three-arm, parallel-group, randomized controlled trial with blinded statistical analysis. The study will consist of 6 weeks of intervention followed by 24 weeks of follow-up, totaling 30 weeks
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Care | Experimental | Other: Osteopathic CareThe participants in the Experimental Group will receive Osteopathic Care (OC) targeting segments affected by somatic dysfunctions to restore function. All individual treatments will be documented in a table detailing the osteopathic technique applied for each identified somatic dysfunction, including musculoskeletal, visceral, and cranial approaches. Each intervention session will last between 30 and 45 minutes. In addition to OC, participants will also receive the same physiotherapy program and pain education booklet as the control group. In the present study, we will not use drugs or devices. |
| Sham Osteopathic Care | Sham comparator | Other: Sham (No Treatment)The participants in the Sham Osteopathic Care (OC) Group will receive sham OC, consisting of light touch, movement arc maneuvers, and simulated osteopathic manipulation, in which the patient is positioned but the final manipulative thrust is not performed. In addition to sham OC, participants will also receive the same physiotherapy program and pain education booklet as the control group. In the present study, we will not use drugs or devices. |
| Physiotherapy | Active comparator | Other: PhysiotherapyThe participants in the Control Group will be managed by a licensed physiotherapist with over 10 years of experience. They will undergo a physiotherapy program and receive a pain education booklet. The physiotherapy program consists of specific motor control exercises for the neck and Mulligan Concept manual therapy techniques. In the present study, we will not use drugs or devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- males and females from Rio de Janeiro - RJ - BR
- over 18 years old
- diagnostic criteria for cervicogenic headache established by the International Classification of Headache Disorders (ICHD-III)
- must report episodic headache for at least 3 months, occurring at least once per week
- present cervical mobility less than 44° on the cervical flexion-rotation test (CFRT)
Key exclusion criteria (5 listed)
- undergoing other physiotherapy, osteopathic, orthodontic, or medical treatment
- present neurological disorders
- have signs of trauma or fracture
- report symptoms of vertigo or tinnitus
- have another condition that may be the origin of the headache
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 |
|---|---|---|
| Osteopathic CareParticipants will receive OC targeting segments affected by somatic dysfunctions to restore function. All individual treatments will be documented in a table detailing the osteopathic technique applied for each identified somatic dysfunction, including musculoskeletal, visceral, and cranial approaches. Each intervention session will last between 30 and 45 minutes. In addition to OC, participants will also receive the same physiotherapy program and pain education booklet as the control group. In the present study, we will not use drugs or devices. | Other | Osteopathic Care |
| PhysiotherapyParticipants will be managed by a licensed physiotherapist with over 10 years of experience. They will undergo a physiotherapy program and receive a pain education booklet. The physiotherapy program consists of specific motor control exercises for the neck and Mulligan Concept manual therapy techniques. In the present study, we will not use drugs or devices. | Other | Physiotherapy |
| Sham (No Treatment)Participants will receive sham OC, consisting of light touch, movement arc maneuvers, and simulated osteopathic manipulation, in which the patient is positioned but the final manipulative thrust is not performed. In addition to sham OC, participants will also receive the same physiotherapy program and pain education booklet as the control group. In the present study, we will not use drugs or devices. | Other | Sham Osteopathic Care |
Primary outcome
Headache-related Disability
Time frame: at baseline and at 6 weeks post-intervention
The primary outcome will be headache-related disability, measured by Headache Impact Test (HIT-6; score range: 36-78). The HIT-6 consists of six questions assessing the impact of headache on daily, physical, social, and work-related activities. Higher scores represent a greater impact. Scores above 60 indicate a very severe impact; scores between 56 and 59 indicate substantial impact; scores between 50 and 55 indicate some impact; and scores below 49 indicate little to no impact.
2 secondary outcomes
Pain Intensity
Time frame: at baseline, at 6 weeks post-intervention and 24 weeks post-intervention.
Perceived Change
Time frame: at 6 weeks post-intervention and 24 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 29550365Olesen J. International Classification of Headache Disorders. Lancet Neurol. 2018 May;17(5):396-397. doi: 10.1016/S1474-4422(18)30085-1. Epub 2018 Mar 14. No abstract available.
- Background: PubMed 6226917Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
- Background: PubMed 34001422Reis F, Palermo TM, Acalantis L, Nogueira LC, Meziat-Filho N, Louw A, Ickmans K. "A journey to learn about pain": the development and validation of a comic book about pain neuroscience education for children. Braz J Phys Ther. 2022 Jan-Feb;26(1):100348. doi: 10.1016/j.bjpt.2021.04.009. Epub 2021 May 2.
- Background: PubMed 39785123Hage R, Demoulin C, J Puentedura E, Brismee JM. Sham treatment? Should it be redefined for its use in manual therapy clinical studies? J Man Manip Ther. 2025 Feb;33(1):1-3. doi: 10.1080/10669817.2025.2448921. Epub 2025 Jan 9. No abstract available.
- Background: PubMed 36265391Hohenschurz-Schmidt D, Draper-Rodi J, Vase L, Scott W, McGregor A, Soliman N, MacMillan A, Olivier A, Cherian CA, Corcoran D, Abbey H, Freigang S, Chan J, Phalip J, Norgaard Sorensen L, Delafin M, Baptista M, Medforth NR, Ruffini N, Skott Andresen S, Ytier S, Ali D, Hobday H, Santosa AANAA, Vollert J, Rice ASC. Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods. Pain. 2023 Mar 1;164(3):469-484. doi: 10.1097/j.pain.0000000000002723. Epub 2022 Jul 11.
- Background: PubMed 39986688Hohenschurz-Schmidt D, Vase L, Draper-Rodi J. From placebos and shams to high-quality control interventions in manual therapy trials to study efficacy and mechanisms. J Man Manip Ther. 2025 Oct;33(5):376-377. doi: 10.1080/10669817.2025.2471477. Epub 2025 Feb 22. No abstract available.
- Background: PubMed 32819150Pradela J, Bevilaqua-Grossi D, Chaves TC, Dach F, Ferreira Carvalho G. Brazilian Portuguese version of the Headache Disability Inventory: Cross-cultural adaptation, validity, and reliability. Cephalalgia. 2021 Feb;41(2):156-165. doi: 10.1177/0333102420949860. Epub 2020 Aug 20.
- Background: PubMed 40049758de Lira MR, Meziat-Filho N, Zuelli Martins Silva G, Castro J, Fernandez J, Guirro RRJ, Berg R, Chaves TC. Efficacy of cognitive functional therapy for pain intensity and disability in patients with non-specific chronic low back pain: a randomised sham-controlled trial. Br J Sports Med. 2025 Jun 18;59(13):912-920. doi: 10.1136/bjsports-2024-109012.
- Individual participant dataSharing planned: Yes. Researchers involved in the study will have access to the final clinical trial dataset and may share it for verification and publication purposes upon reasonable request. The principal investigator will be responsible for data management and will ensure that all study data are stored in both physical and digital formats for 5 years after study completion. The data entry spreadsheet will be updated by the investigator based on collected assessment forms. Study data will be entered into a password-protected database, with access restricted to authorized study personnel. Data quality will be ensured through double-checking of entries and periodic audits. All participant data will be de-identified prior to analysis to ensure confidentiality.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Care and Physiotherapy in people with Cervicogenic Headache, run by Centro Universitário Augusto Motta at 1 site in Brazil.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 31 Aug 2026. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PAULA O ESTEVES, MSc (+5521992255928, paulaesteves@souunisuam.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache-related Disability (time frame: at baseline and at 6 weeks post-intervention). 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 NCT07794319, which also lists 8 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 31 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.