Cervicogenic HeadacheNCT06434051
Traditional Chinese Cervical Manipulation for Cervicogenic Headache
A study testing Traditional Chinese cervical manipulation in people with Cervicogenic Headache, run by Hong Kong Baptist University at 2 sites in Hong Kong.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Traditional Chinese cervical manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Nov 2024to 30 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- Any headache fulfilling criterion C b. Clinical and/or imaging evidence of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be able to cause headache c. Evidence of causation demonstrated by at least two of the following: i. headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion ii. headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion iii. cervical range of motion is reduced and headache is made significantly worse by provocative manoeuvre iv. headache is abolished following diagnostic blockade of a cervical structure or its nerve supply v. Not better accounted for by another ICHD-3 diagnosis
Show all 11Show fewer
- 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
- The frequency, dosage, and type of painkillers have remained stable over the past 6 weeks
- Score at least 10 points on the Neck Disability Index -
Who cannot join
- 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.
- With suspected cervical spinal stenosis, cervical spinal cord lesions, cervical vascular disease, cervical nerve root disease, cervical instability, or cervical fracture
- Has suffered from a whiplash injury within the past 6 weeks
- Had surgery on the neck or head
- Currently pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Hong Kong Baptist University
Hong Kong
Lui Seng Chun,119 Lai Chi Kok Road, Mong Kok
Hong Kong
About this study
Official title: The Effect of Traditional Chinese Cervical Manipulation for Cervicogenic Headache: a Pilot Randomized, Single-blind, Placebo-controlled Trial
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).
- Conditions
- Cervicogenic Headache
- Being tested
- Traditional Chinese cervical manipulation, Sham manipulation
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese cervical manipulationOther
Initial Assessment: The participant will lie supine while the PI will perform the CFRT to identify the side with more restricted rotation.
Positioning (Left Restriction Example): The PI will support the lower jaw with the right hand and will passively rotate the neck 70-80° (or to the limit of comfort) toward the unrestricted side.
Hand Placement: The right fingers will support the right C1-C3 transverse processes, while the left thumb will stabilize the left C2 transverse process.
Traction and Thrust: While maintaining rotation, the PI will apply a steady traction force to open the cranio-cervical and atlanto-axial joints. Once felt, a sudden high-velocity, low-amplitude (HVLA) pulling force will be delivered.
Completion: The procedure will be repeated on the opposite side, followed by a 5-10 minute supine rest period for the participant.
Sham manipulationOther
Initial Positioning: Assuming a right-side rotation restriction, the PI will support the participant's lower jaw and will passively rotate the neck 70-80° toward the unrestricted side.
Hand Placement: The PI will use the left fingers to support the right-side transverse processes of C4-C6 and the left thumb to support the left-side transverse process of C6.
Traction Application: A steady traction force will be applied such that joint space increases are limited specifically to the C4/C5 level and below, avoiding the upper cervical region. The PI will then deliver a low-amplitude pulling force at a slower speed than the standard TCMT to prevent vertebral realignment or significant joint widening.
Completion: The procedure will be repeated on the opposite side, after which the participant will rest supine for 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese cervical manipulation | Experimental | Initial Assessment: The participant will lie supine while the PI will perform the CFRT to identify the side with more restricted rotation.
Positioning (Left Restriction Example): The PI will support the lower jaw with the right hand and will passively rotate the neck 70-80° (or to the limit of comfort) toward the unrestricted side.
Hand Placement: The right fingers will support the right C1-C3 transverse processes, while the left thumb will stabilize the left C2 transverse process.
Traction and Thrust: While maintaining rotation, the PI will apply a steady traction force to open the cranio-cervical and atlanto-axial joints. Once felt, a sudden high-velocity, low-amplitude (HVLA) pulling force will be delivered.
Completion: The procedure will be repeated on the opposite side, followed by a 5-10 minute supine rest period for the participant. Receives: Other: Traditional Chinese cervical manipulation |
| Sham manipulation | Sham comparator | Initial Positioning: Assuming a right-side rotation restriction, the PI will support the participant's lower jaw and will passively rotate the neck 70-80° toward the unrestricted side.
Hand Placement: The PI will use the left fingers to support the right-side transverse processes of C4-C6 and the left thumb to support the left-side transverse process of C6.
Traction Application: A steady traction force will be applied such that joint space increases are limited specifically to the C4/C5 level and below, avoiding the upper cervical region. The PI will then deliver a low-amplitude pulling force at a slower speed than the standard TCMT to prevent vertebral realignment or significant joint widening.
Completion: The procedure will be repeated on the opposite side, after which the participant will rest supine for 5-10 minutes. Receives: Other: Sham manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI) scoring
It is used to evaluate cervical functional disability It has good reliability and validity, reflecting the degree of limitation on living ability and the impact on quality of life. The higher the score, the more severe the symptoms.
Measured: Baseline, week 2, week 4 and week 8
Secondary outcomes (2)
Active cervical range of motion
to evaluate the range neck flexion, extension, left and right lateral flexion, left and right rotation. The measuring instrument will be the cervical goniometer.
Measured: Baseline, week 2, week 4 and week 8
Online headache diary:
All participants are required to complete an online headache diary daily. It will include the following items: the time of headache onset, duration, pain intensity, and the type and frequency of painkillers taken
Measured: Baseline, week 2, week 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Nov 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This intervention involves cervical mobilization that constitutes elements of cervical rotation and traction.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHOW Chi Ho, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434051
- Sponsor's protocol ID
- Manipulation CGH
- Status last verified
- Nov 2025
- First submitted
- 23 May 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No