Selecting Effective Combinations of Treatment for Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Behavioral: AcTIVE-CBT; Behavioral: TBSCE; Procedure: Lumbar medial branch nerve radiofrequency ablation (LRFA); Procedure: Simulated LRFA with targeted steroid injections

• Registration Number: NCT03520387
• Lead Sponsor: VA Office of Research and Development

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, 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

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.

Study Timeline

• Study First Submitted: 2018-04-27
• Study First Submitted QC: 2018-04-27
• Study First Posted: 2018-05-09
• Study Start: 2018-11-15
• Primary Completion: 2020-06-30
• Study Completion: 2020-08-30
• Results First Submitted: 2021-06-14
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-10
• Last Update Submitted: 2021-08-10
• Results First Posted: 2021-09-05
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
AcTIVE-CBT	AcTIVE-CBT	Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT)
TBSCE	TBSCE	Telephone-based self-directed CBT and education (TBSCE)
Lumbar medial branch nerve radiofrequency ablation (LRFA)	Lumbar medial branch nerve radiofrequency ablation (LRFA)	Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves
Simulated lumbar radiofrequency ablation (simulated LRFA)	Simulated LRFA with targeted steroid injections	Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves(simulated LRFA), with targeted steroid injections

Primary Outcome Measures

Name	Time	Method
Roland-Morris Disability Questionnaire	3 months	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States