Traditional Chinese Cervical Manipulation for Cervicogenic Headache (NCT06434051) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Traditional Chinese Cervical Manipulation for Cervicogenic Headache
Hong Kong84 participantsStarted 2024-11-01
Plain-language summary
Background Cervical spondylosis is a prevalent condition. Studies has shown that it is a leading cause for headache, which is termed cervicogenic headache (CGH). The prevlance of CGH among severe headache is 17.5%. While conventional treatments, such as physical therapy and surgery, is effective in controlling symptoms, the effect was found to be short-lasting. There is existing clinical evidence supporting traditional Chinese cervical manipulation (CCM) as a viable treatment for CGH.
Objective To preliminarily assess the feasibility, safety, and effectiveness of CCM on patients with CGH, and to optimize parameters for a future large-scale trial.
Method This study is a pilot randomized, controlled, single-blind trial. 84 participants will be randomized evenly to receive either CCM or sham manipulation for 4 weeks. Outcome measurements will be conducted at baseline, week 2, week 4 and week 8 on cervical functional disability, cervical range of motion, and data on headache onset and painkiller assumption. Adverse events will be recorded using the Common Terminology Criteria for Adverse Events (CTCAE).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. The diagnostic criteria of cervical spondylosis according to "The expert consensus on the classification, diagnosis, and non-surgical treatment of cervical spondylosis (2018)" are as follows:
✓. Patients must have a chief complaint of abnormal sensations such as pain in the occipital, neck, or shoulder area, and can be accompanied by related localized pain and tenderness
✓. X-ray imaging shows degenerative changes in the cervical spine
✓. Other conditions that could cause symptoms of the neck are excluded
✓. The diagnostic criteria of CGH as listed by ICHD-3:
✓. Of age between 18 to 65 years old
✓. Headache recurs for at least three months
✓. The frequency of headaches in the past three months is at least once a week
Exclusion criteria
✕. Presented with red flag presentations of headache listed in the SNNOOP10 list (systemic symptoms/signs and disease, neurologic symptoms or signs, onset sudden or onset after the age of 40 years, and change of headache pattern), including fever, vascular and non-vascular intracranial diseases, history of brain tumor, brain neurological dysfunction or disorder, etc.