The Effect of Traditional Chinese Cervical Manipulation for Cervicogenic Headache: a Pilot Randomized, Single-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Neck Disability Index (NDI) scoring
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 -
排除标准
- •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
研究组 & 干预措施
Traditional Chinese cervical manipulation
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.
干预措施: Traditional Chinese cervical manipulation (Other)
Sham manipulation
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.
干预措施: Sham manipulation (Other)
结局指标
主要结局
Neck Disability Index (NDI) scoring
时间窗: 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.
次要结局
- Active cervical range of motion(Baseline, week 2, week 4 and week 8)
- Online headache diary:(Baseline, week 2, week 4 and week 8)
研究者
CHOW Chi Ho
Associate Professor of Practice
Hong Kong Baptist University