Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620133
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
Pain Education and Patient-led Goal Setting in Adults with Chronic Low Back Pain a Randomised Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Pain Education and Patient-led Goal Setting Compared to Supervised Group Exercise on Pain and Disability in Adults with Chronic Low Back Pain a Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPACITY
Brief Summary:
The goal of this clinical trial is to investigate the effectiveness of two treatments for adults with chronic low back pain The main question this study seeks to answer is 34In adults with chronic low back pain what is the effectiveness of pain education and patient-led goal setting compared to supervised exercise on reducing pain intensity and disability34
A total of 392 participants will be randomised into two groups 1 pain education and patient-led goal setting or 2 supervised group exercise Participants randomised to the pain education and patient-led goal setting group will receive 5 sessions of 45-60 min each over 8 weeks Participants randomised to supervised group exercise will be able to attend up to 2 x 45min classes per week over 8 weeks Both interventions will be delivered online via telehealth Outcomes will be assessed at baseline and week 8 26 and 52
A total of 392 participants will be randomised into two groups 1 pain education and patient-led goal setting or 2 supervised group exercise Participants randomised to the pain education and patient-led goal setting group will receive 5 sessions of 45-60 min each over 8 weeks Participants randomised to supervised group exercise will be able to attend up to 2 x 45min classes per week over 8 weeks Both interventions will be delivered online via telehealth Outcomes will be assessed at baseline and week 8 26 and 52
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None