Selecting Effective Combinations of Treatment for Low Back Pain (SELECT LBP)
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|ClinicalTrials.gov Identifier: NCT03520387|
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : November 5, 2019
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 uses 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, procedural/technical, 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 both the LRFA and AcTIVE-CBT treatment arms are innovations on their own, the most unique aspect of the proposed study is the use of the factorial RCT design to examine whether 'stacking' disparate CLBP treatments can result in greater treatment effects than that of each treatment 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 produce valid effect size estimates that will inform a future large-scale multicenter RCT (likely funded by a programmatic or cooperative grant mechanism) to determine the efficacy of LRFA, AcTIVE-CBT, or combined LRFA + AcTIVE-CBT, for Veterans with CLBP.
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Procedure: Lumbar medial branch nerve radiofrequency ablation (LRFA) Procedure: Simulated LRFA with targeted steroid injections Behavioral: AcTIVE-CBT Behavioral: TBSCE||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||The proposed research will use 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) (vs. simulated LRFA control), and 2) a novel video telehealth tablet- and personal computer (PC)-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program ("AcTIVE-CBT") (vs. a telephone-based supportive contact and education control). This pilot RCT will involve 30 Veterans with chronic low back pain (CLBP) who will be followed to evaluate functional recovery for 3 months.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||Some investigators are not masked, for safety monitoring purposes.|
|Official Title:||Combined Treatments to Optimize Functional Recovery in Veterans With Chronic Low Back Pain|
|Actual Study Start Date :||November 15, 2018|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Lumbar medial branch nerve radiofrequency ablation (LRFA)
Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves
Procedure: Lumbar medial branch nerve radiofrequency ablation (LRFA)
Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
Active Comparator: Simulated lumbar radiofrequency ablation (simulated LRFA)
Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves(simulated LRFA), with targeted steroid injections
Procedure: Simulated LRFA with targeted steroid injections
Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
Other Name: Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves(simulated LRFA), with targeted steroid injections to the medial branch nerves.
Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT)
AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
Other Name: Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT).
Active Comparator: TBSCE
Telephone-based self-directed CBT and education (TBSCE)
TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
Other Name: Telephone-based supportive contact and education (TBSCE)
- Roland-Morris Disability Questionnaire [ Time Frame: 3 months ]The RDQ is a validated, commonly used, and widely accepted 'legacy' measure of back-related functional limitations (range 0 to 24, with higher scores representing greater functional limitations).
- Activity tracker-assessed average daily step counts (change scores) [ Time Frame: 3 months ]Change scores will be calculated as compared to average daily step count pre-randomization.
- Low Back Pain Intensity (0-10 numerical pain rating scale) [ Time Frame: 3 months ]Higher numerical pain ratings reflect greater pain intensity.
- PROMIS Global Health short form 10 [ Time Frame: 3 months ]Global quality of life measure. There are two subscales, the physical component summary score and the mental component summary score. Each range from 4-20, with higher scores reflecting greater quality of life
- Average morphine equivalent daily dose [ Time Frame: Baseline, 1 month, 2 months, 3 months ]Self-reported average morphine equivalent daily dose over the past 3 days. There will also be optional monthly reassessments for this measure thereafter for participants who wish to do so, until the end of the funding period.
- Global Perceived Effect (how back pain has changed since baseline) [ Time Frame: 3 months ]7-point Likert scale where 1 represents 'complete recovery' and 7 represents 'become worse than ever'
- Expected Low Back Pain Intensity (0-10 numerical pain rating scale) if not using pain medications [ Time Frame: 3 months ]Higher numerical pain ratings reflect greater pain intensity.
- Participant-reported satisfaction [ Time Frame: 3 months ]5-point Likert scale where 1 represents 'completely satisfied' and 5 represents 'completely dissatisfied'
- BRFSS self-reported physical activity per week [ Time Frame: 3 months ]Self-reported minutes per week of moderate and vigorous exercise
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520387
|Contact: Pradeep Suri, MD||(206) 314-3256||Pradeep.Suri@va.gov|
|United States, Washington|
|VA Puget Sound Health Care System Seattle Division, Seattle, WA||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Pradeep Suri, MD 206-314-3256 Pradeep.Suri@va.gov|
|Principal Investigator: Pradeep Suri, MD|
|Principal Investigator:||Pradeep Suri, MD||VA Puget Sound Health Care System Seattle Division, Seattle, WA|