Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320249
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-24
Brief Title:
Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy
Sponsor:
Wangjing Hospital China Academy of Chinese Medical Sciences
Organization:
Wangjing Hospital China Academy of Chinese Medical Sciences
Study Overview
Official Title:
Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy A Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
The evidence for different frequencies of rotation-traction manipulation treatment in cervical radiculopathy is insufficient This study determined whether 3 sessions per week of rotation-traction manipulation treatment are superior to 1 session per week for symptomatic outcomes in cervical radiculopathy based on a multicenter randomized controlled trial
Detailed Description:
This study slated to be conducted across four sub-centers including the Wangjing Hospital of the China Academy of Chinese Medical Sciences aims to recruit 216 patients diagnosed with cervical radiculopathy Employing a central randomization method participants will be stratified into three groups high-frequency manipulation low-frequency manipulation and cervical traction
In the high-frequency manipulation group patients will undergo rotation-traction manipulation three times weekly while the low-frequency manipulation group will receive the same intervention once a week The cervical traction group will be subjected to cervical traction three times a week Each group will undergo 4-week treatment with a subsequent 16-week follow-up resulting in a total study duration of 20 weeks
Outcomes assessments will be conducted at seven specific time points baseline 2 weeks after treatment 4 weeks after treatment and during follow-up at weeks 4 8 12 and 16 Outcomes include scores from the Visual Analog Scale VAS for pain VAS for numbness Neck Disability Index NDI Short Form-12 SF-12 health survey and monitoring of adverse reactions Following the first treatment session and 4 weeks after treatment Expectation Treatment Credibility Scale ETCS will be appraised Furthermore the study will record the overall cost incurred by each group after 4 weeks of treatment and the recurrence rates during the follow-up period
In the high-frequency manipulation group patients will undergo rotation-traction manipulation three times weekly while the low-frequency manipulation group will receive the same intervention once a week The cervical traction group will be subjected to cervical traction three times a week Each group will undergo 4-week treatment with a subsequent 16-week follow-up resulting in a total study duration of 20 weeks
Outcomes assessments will be conducted at seven specific time points baseline 2 weeks after treatment 4 weeks after treatment and during follow-up at weeks 4 8 12 and 16 Outcomes include scores from the Visual Analog Scale VAS for pain VAS for numbness Neck Disability Index NDI Short Form-12 SF-12 health survey and monitoring of adverse reactions Following the first treatment session and 4 weeks after treatment Expectation Treatment Credibility Scale ETCS will be appraised Furthermore the study will record the overall cost incurred by each group after 4 weeks of treatment and the recurrence rates during the follow-up period
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None