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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
Centro Universitário Augusto Motta
Rio de Janeiro, Rio de Janeiro, Brazil
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.
Time frame: at baseline and at 6 weeks post-intervention
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.
Time frame: 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.
Time frame: at 6 weeks post-intervention and 24 weeks post-intervention
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