Clinical trial NCT06434051: Traditional Chinese Cervical Manipulation for Cervicogenic Headache
Official title: The Effect of Traditional Chinese Cervical Manipulation for Cervicogenic Headache: a Pilot Randomized, Single-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervicogenic Headache
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This intervention involves cervical mobilization that constitutes elements of cervical rotation and traction.
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Neck Disability Index (NDI) scoring
timeFrame: Baseline, week 2, week 4 and week 8
Secondary outcomes:
measure: Active cervical range of motion
timeFrame: Baseline, week 2, week 4 and week 8
measure: Online headache diary:
timeFrame: Baseline, week 2, week 4 and week 8
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Baptist University
city: Hong Kong
country: Hong Kong
facility: Lui Seng Chun,119 Lai Chi Kok Road, Mong Kok
Study officials:
References: