NCT06434051

Traditional Chinese Cervical Manipulation for Cervicogenic Headache

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Hong Kong Baptist University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Cervicogenic Headache

Interventions

Type	Name	Description
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).
OTHER	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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-12-30
• Completion: 2026-03-30
• First posted: 2024-05-30
• Last updated: 2024-10-08

Locations

2 sites across 1 country: Hong Kong