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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying traditional Chinese cervical manipulation for cervicogenic headache — how does this approach compare to what you'd normally recommend for my neck-related headaches, and is it something worth exploring for my situation?
2The trial is measuring success using the Neck Disability Index, which tracks how much neck pain affects daily activities — based on my current level of neck disability, would I be likely to see meaningful improvement with this type of manipulation?
3Since this trial is 'active but not recruiting,' I can't join it now — but are there similar studies or clinics offering traditional Chinese cervical manipulation that you'd consider safe and appropriate for me to look into?
4Cervical manipulation carries some known risks, especially for certain patients — given my specific health history, are there any reasons you'd be cautious about me trying this kind of hands-on neck treatment at all?
5If this trial's approach isn't accessible to me right now, what are the standard or alternative treatments for cervicogenic headache that you think I should try first, and how would we know if they're working?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.