Ignite Creation Date:
2024-05-06 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03520387
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2018-04-27
Brief Title:
Selecting Effective Combinations of Treatment for Low Back Pain
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Combined Treatments to Optimize Functional Recovery in Veterans With Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2021-08
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:
SELECT LBP
Brief Summary:
Back pain is the 1 contributor to disability in the United States US and second only to hearing problems as a reason for new Veteran disability compensation The societal burden of back pain is driven mainly by chronic low back pain CLBP defined as low back pain persisting for 3 months Since most individual treatments for CLBP have only small effects on functional recovery combining CLBP treatments has recently been recommended as a priority area for research However few prior studies of CLBP have been properly designed to evaluate the effects of treatment combinations Large effects on functional recovery from CLBP may require combining interventions that each target different points on a theoretical pathway to functional recovery Procedural treatments for CLBP aim primarily to address early stages in the pathway to functional recovery such as problems with the lumbar spinal structures or low back pain itself In contrast behavioral interventions for CLBP generally have effects not only on pain itself but also work by mitigating the degree to which the sensation of low back pain impacts function well-being and quality of life These represent later stages in the pathway to functional recovery from CLBP Combining procedural and behavioral treatments may have great potential for achieving large magnitude treatment effects for CLBP in Veterans
The proposed research assesses the feasibility of using a 2 x 2 factorial randomized controlled trial RCT design to examine the individual and combined effects of 1 lumbar medial branch nerve radiofrequency ablation LRFA a commonly used procedural intervention to target low back pain severity and 2 a novel video telehealth tablet- and personal computer PC-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program AcTIVE-CBT a behavioral intervention designed primarily to target functional limitations both secondary to and independent of improvements in pain The LRFA treatment to be used in the proposed study addresses the major patient selection proceduraltechnical methodologic and reporting limitations of prior studies AcTIVE-CBT addresses problems with Veteran access and compliance associated with conventional cognitive behavioral therapy CBT delivered in clinic and uses currently available activity tracking technology to better promote activity and behavior change as compared to conventional CBT This pilot RCT involves recruitment of up to 30 Veterans with CLBP who will be followed to evaluate functional recovery for up to 3 months to reach a goal of 20 Veterans completing the 3-month primary outcome The primary outcome is participant-reported back-related functional limitations mobility and ADLs at 3 months as measured by the validated Roland-Morris Disability Questionnaire Secondary outcomes include activity tracker-assessed step counts back pain intensity reduction in opioid use and quality of life Although the proposed pilot study is unlikely to definitively address whether these treatments alone or in combination have significant effects on functional recovery it will inform a future large-scale multicenter RCT to determine the efficacy of LRFA AcTIVE-CBT or combined LRFA AcTIVE-CBT for Veterans with CLBP
The proposed research assesses the feasibility of using a 2 x 2 factorial randomized controlled trial RCT design to examine the individual and combined effects of 1 lumbar medial branch nerve radiofrequency ablation LRFA a commonly used procedural intervention to target low back pain severity and 2 a novel video telehealth tablet- and personal computer PC-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program AcTIVE-CBT a behavioral intervention designed primarily to target functional limitations both secondary to and independent of improvements in pain The LRFA treatment to be used in the proposed study addresses the major patient selection proceduraltechnical methodologic and reporting limitations of prior studies AcTIVE-CBT addresses problems with Veteran access and compliance associated with conventional cognitive behavioral therapy CBT delivered in clinic and uses currently available activity tracking technology to better promote activity and behavior change as compared to conventional CBT This pilot RCT involves recruitment of up to 30 Veterans with CLBP who will be followed to evaluate functional recovery for up to 3 months to reach a goal of 20 Veterans completing the 3-month primary outcome The primary outcome is participant-reported back-related functional limitations mobility and ADLs at 3 months as measured by the validated Roland-Morris Disability Questionnaire Secondary outcomes include activity tracker-assessed step counts back pain intensity reduction in opioid use and quality of life Although the proposed pilot study is unlikely to definitively address whether these treatments alone or in combination have significant effects on functional recovery it will inform a future large-scale multicenter RCT to determine the efficacy of LRFA AcTIVE-CBT or combined LRFA AcTIVE-CBT for Veterans with CLBP
Detailed Description:
The proposed research assesses the feasibility of using an innovative application of the 2 x 2 factorial randomized controlled trial RCT design to examine the individual and combined effects of 1 lumbar medial branch nerve radiofrequency ablation LRFA a commonly used procedural intervention to target low back pain severity and 2 a novel video telehealth tablet- and personal computer PC-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program AcTIVE-CBT a behavioral intervention designed primarily to target functional limitations both secondary to and independent of improvements in pain The LRFA treatment to be used in the proposed study addresses the major patient selection proceduraltechnical methodologic and reporting limitations of prior studies AcTIVE-CBT addresses problems with Veteran access and compliance associated with conventional cognitive behavioral therapy CBT delivered in clinic and uses currently available activity tracking technology to better promote activity and behavior change as compared to conventional CBT This pilot RCT involves recruitment of up to 30 Veterans with CLBP who will be followed to evaluate functional recovery for up to 3 months to reach a goal of 20 Veterans completing the 3-month primary outcome The primary outcome is participant-reported back-related functional limitations mobility and ADLs at 3 months as measured by the validated Roland-Morris Disability Questionnaire Secondary outcomes include activity tracker-assessed step counts back pain intensity reduction in opioid use and quality of life The investigators hypothesize that 1 each individual treatment will result in improvements in back-related functional limitations and secondary outcomes compared to control and 2 combined treatment will produce greater treatment effects than each of the individual treatments alone Although the proposed pilot study is unlikely to definitively address whether these treatments alone or in combination have significant effects on functional recovery it will inform a future large-scale multicenter RCT to determine the efficacy of LRFA AcTIVE-CBT or combined LRFA AcTIVE-CBT for Veterans with CLBP
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?:
False
Is an FDA AA801 Violation?:
None