Osteopathic Care Combined With Physiotherapy and Pain Education for Cervicogenic Headache

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.

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