Cervicogenic Headache
Conditions
Keywords
Cervicogenic Headache, Secondary Headache Disorders, Musculoskeletal Manipulations, Osteopathic Manipulation, Osteopathic Medicine
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.
Interventions
OTHEROsteopathic Care
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.
OTHERPhysiotherapy
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.
OTHERSham (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.
Sponsors
Centro Universitário Augusto Motta
Instituto Brasileiro de Osteopatia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache-related Disability | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 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. |
| Perceived Change | 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. |
Countries
Brazil
Contacts
CONTACTPAULA O ESTEVES, MSc
CONTACTARTHUR S FERREIRA, DSc
Outcome results
None listed