Osteopathic Care Combined With Physiotherapy and Pain Education for Cervicogenic Headache
1 other identifier
interventional
120
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2026
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
August 20, 2026
CompletedFirst Posted
Study publicly available on registry
August 31, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
Study Completion
Last participant's last visit for all outcomes
November 1, 2028
August 31, 2026
August 1, 2026
2 years
August 20, 2026
August 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
at baseline and at 6 weeks post-intervention
Secondary Outcomes (2)
Pain Intensity
at baseline, at 6 weeks post-intervention and 24 weeks post-intervention.
Perceived Change
at 6 weeks post-intervention and 24 weeks post-intervention
Study Arms (3)
Osteopathic Care
EXPERIMENTALThe 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 COMPARATORThe 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 COMPARATORThe 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Universitário Augusto Motta
Rio de Janeiro, Rio de Janeiro, 21041-020, Brazil
Related Publications (8)
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.
PMID: 29550365BACKGROUNDPrice 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.
PMID: 6226917BACKGROUNDReis 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.
PMID: 34001422BACKGROUNDHage 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.
PMID: 39785123BACKGROUNDHohenschurz-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.
PMID: 36265391BACKGROUNDHohenschurz-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.
PMID: 39986688BACKGROUNDPradela 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.
PMID: 32819150BACKGROUNDde 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.
PMID: 40049758BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The outcome assessor, the osteopath responsible for the interventions and the physiotherapist delivering the physiotherapy program and pain education will not be blinded to group allocation. However, immediately postintervention, the participants will be asked if they received the sham or active intervention, as a means to confirm the blinding. The statistician will be blinded to group allocation. The possible answers will be: "sham", "active treatment" or "I don´t know". The "I don't know" response will be assigned proportionally to both groups.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 20, 2026
First Posted
August 31, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
August 31, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- for 5 years after study completion.
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.