Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-03-07 @ 9:03 PM
Study NCT ID:
NCT06434051
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Chinese Cervical Manipulation for Cervicogenic Headache
Sponsor:
Hong Kong Baptist University
Organization:
Study Overview
Official Title:
The Effect of Traditional Chinese Cervical Manipulation for Cervicogenic Headache: a Pilot Randomized, Single-blind, Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: