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NCT Number: NCT07794319

Osteopathic Care Combined With Physiotherapy and Pain Education for Cervicogenic Headache

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.

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Key information

Conditions

Cervicogenic Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Traumatic Headache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Universitário Augusto Motta

Rio de Janeiro, 21041-020, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Osteopathic care

Other

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.

Physiotherapy

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain Intensity

    Time frame: at baseline, at 6 weeks post-intervention and 24 weeks post-intervention.

    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.

  2. Perceived Change

    Time frame: at 6 weeks post-intervention and 24 weeks post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ARTHUR S FERREIRA, DSc

CONTACT

[email protected]

+5521999151800

PAULA O ESTEVES, MSc

CONTACT

[email protected]

+5521992255928

Sponsors and collaborators

Lead sponsor

Centro Universitário Augusto Motta

Other

Collaborators

  • Instituto Brasileiro de Osteopatia

Registry information

Official study title

Osteopathic Care Combined With Physiotherapy and Pain Education for Cervicogenic Headache: Study Protocol for a Three-arm Pragmatic Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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