Selecting Effective Combinations of Treatment for Low Back Pain

Study Overview
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Brief Summary
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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, 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. 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
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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, 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 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.

Official Title
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Combined Treatments to Optimize Functional Recovery in Veterans With Chronic Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Lumbar medial branch nerve radiofrequency ablation (LRFA)
* Procedure: Simulated LRFA with targeted steroid injections
* Behavioral: AcTIVE-CBT
* Behavioral: TBSCE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Veteran seeking care in the VA Puget Sound Health Care System Chronic low back pain of duration at least 3 months Low back pain intensity numerical rating scale (NRS) 4 (must be 4 or higher) Has failed 1st line rehabilitative treatments, including physical therapy, yoga, tai chi, chiropractic or osteopathic manipulation, and/or massage. Must be able to provide informed consent and complete the assessment instruments accurately Must have access to a computer, tablet, or smartphone with internet access at home or at work 'Positive responses' to 2 separate sets of lumbar medial branch blocks (MBBs: low volume anesthetic blocks of the medial branches of the dorsal rami using 0.5cc or less of lidocaine or bupivacaine), including at least 50% pain improvement of typical low back pain, with onset of typical lumbar back pain relief within 30 mins and relief lasting at least 30 mins after the onset of initial pain relief Considered a candidate for unilateral or bilateral LRFA at 2-4 spinal levels (between L1 and S1) Exclusion Criteria: Clinical suspicion that the current low back pain symptoms have a significant and sustained component that is attributed to specific lumbar spine-related syndromes including lumbosacral radicular syndrome (radiculopathy), symptomatic lumbar spinal stenosis (neurogenic claudication), with confirmatory imaging findings, spinal instability requiring surgery, or 'red flag' conditions (infection/ malignancy/ fracture) Pregnant females, prisoners, or the cognitively impaired Prior lumbar RFA Prior lumbar spine surgery involving the levels where LRFA is to be performed, within the past 2 years Lumbar fusion or instrumentation involving the levels where LRFA is to be performed Prior CBT for chronic pain Primary psychotic or major thought disorder (lifetime), any active suicidal/homicidal ideation (past 6 months), unstable or severe psychiatric/behavioral conditions (e.g. delirium, mania, psychosis) Hospitalization for psychiatric reasons involving psychosis other than suicidal ideation, homicidal ideation, and/or PTSD, in the past 5 years Cognitive limitations that would prevent participation Severe medical comorbidities posing major functional limitations in ambulation and function or medical prognosis, including vascular, pulmonary or coronary artery disease, metastatic cancer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 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) (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 self-directed CBT 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar medial branch nerve radiofrequency ablation (LRFA)<br>Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves | Procedure: Lumbar medial branch nerve radiofrequency ablation (LRFA)<br>* 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.<br>|
| Active Comparator: Simulated lumbar radiofrequency ablation (simulated LRFA)<br>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<br>* 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.<br>* Other names: Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves(simulated LRFA), with targeted steroid injections to the medial branch nerves.;|
| Experimental: AcTIVE-CBT<br>Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT) | Behavioral: AcTIVE-CBT<br>* 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.<br>* Other names: Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT).;|
| Active Comparator: TBSCE<br>Telephone-based self-directed CBT and education (TBSCE) | Behavioral: TBSCE<br>* 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.<br>* Other names: Telephone-based supportive contact and education (TBSCE);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland-Morris Disability Questionnaire | The RMDQ 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). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity Tracker-assessed Average Daily Step Counts (Change Scores) | Change scores will be calculated as compared to average daily step count pre-randomization. | 3 months | 
| Low Back Pain Intensity (0-10 Numerical Pain Rating Scale) | Higher numerical pain ratings reflect greater pain intensity. | 3 months | 
| PROMIS Global Health Short Form 10 | 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 | 3 months | 
| Average Morphine Equivalent Daily Dose | Self-reported average morphine equivalent daily dose over the past 3 days. | 3 months | 
| Global Perceived Effect (How Back Pain Has Changed Since Baseline) | 7-point Likert scale where 3 represents 'complete recovery', 0 represents 'not changed', and -3 represents 'become worse than ever' | 3 months | 
| Expected Low Back Pain Intensity (0-10 Numerical Pain Rating Scale) if Not Using Pain Medications | Higher numerical pain ratings reflect greater pain intensity. | 3 months | 
| Participant-reported Satisfaction | 5-point Likert scale where 2 represents 'completely satisfied', 0 represents 'neutral', and -2 represents 'completely dissatisfied' | 3 months | 
| BRFSS Self-reported Physical Activity Per Week | Self-reported activity equivalent minutes per week | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Chronic pain