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

Cervicogenic Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434051
• Other study ID #: Manipulation CGH
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: March 30, 2026

Study information

• Verified date: May 2024
• Source: Hong Kong Baptist University
• Contact: Chi Ho Chow, Phd
• Phone: 34118728
• Email: barton[@]hkbu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%. 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: March 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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:

1. 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

2. X-ray imaging shows degenerative changes in the cervical spine

3. Other conditions that could cause symptoms of the neck are excluded

2. 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

3. Of age between 18 to 65 years old

4. Headache recurs for at least three months

5. The frequency of headaches in the past three months is at least once a week

6. The frequency, dosage, and type of painkillers have remained stable over the past 6 weeks

7. Score at least 10 points on the Neck Disability Index -

Exclusion Criteria:

1. 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.

2. With suspected cervical spinal stenosis, cervical spinal cord lesions, cervical vascular disease, cervical nerve root disease, cervical instability, or cervical fracture

3. Has suffered from a whiplash injury within the past 6 weeks

4. Had surgery on the neck or head

5. Currently pregnant or breastfeeding

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Post-Traumatic Headache

Intervention

Other:
• Traditional Chinese cervical manipulation
The CMP will first palpate the transverse processes of C1 and C2. The transverse process with apparent tenderness will be regarded as the pain side. The right side will be the painful side for the following example). During the manipulation, the CMP will use his left hand to support the lower jaw and passively rotate the neck to the left side by 70-75 degrees (or to the maximum angle without discomfort). The physician's right-hand fingers will support the left-side transverse processes of C1 and C2, and the thumb and thenar muscle will be placed on the spinous process and occipital area. While maintaining a passive left neck rotation, the physician will increase the rotation angle by 5-10 degrees with both hands under a sudden pulling force. The above procedure will be repeated on the right side (pain side).
• Sham manipulation
The posture and position of the participant and the practitioner and the procedure are the same as the CCM technique. The right side will be regarded as the pain side once again. When performing the sham technique, the CMP uses the left hand to support the lower jaw position and passively rotates the neck to the left side by 70-75 degrees or to the maximum angle. The right hand presses the upper inner corner of the right scapula. While maintaining the passive left rotation of the neck, the right hand slowly exerts force downwards and outwards on the inner side of the scapula. The left hand only maintains the left rotation of the neck without any pulling force. After completion, repeat the above actions on the right side. After the technique is completed, participants can get up after resting for 5-10 minutes.

Locations

Country	Name	City	State
Hong Kong	Hong Kong Baptist University	Hong Kong
Hong Kong	Lui Seng Chun,119 Lai Chi Kok Road, Mong Kok	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, week 2, week 4 and week 8
Secondary	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.	Baseline, week 2, week 4 and week 8
Secondary	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	Baseline, week 2, week 4 and week 8