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NCT Number: NCT06434051

Traditional Chinese Cervical Manipulation for Cervicogenic Headache

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cervicogenic Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Traumatic Headache

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Baptist University, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

a. 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

  • 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 -

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.
  • 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

Treatment and study plan

Traditional Chinese cervical manipulation

Other

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 Manipulation

Other

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.

Primary outcomes

  1. Neck Disability Index (NDI) scoring

    Time frame: Baseline, week 2, week 4 and week 8

    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.

Secondary outcomes

  1. Active cervical range of motion

    Time frame: Baseline, week 2, week 4 and week 8

    to evaluate the range neck flexion, extension, left and right lateral flexion, left and right rotation. The measuring instrument will be the cervical goniometer.

  2. Online headache diary:

    Time frame: Baseline, week 2, week 4 and week 8

    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

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Registry information

Official study title

The Effect of Traditional Chinese Cervical Manipulation for Cervicogenic Headache: a Pilot Randomized, Single-blind, Placebo-controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 30, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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