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).
Group
Value
95% CI
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
9.8
± 4.1
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
5.3
± 5.9
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
13.3
± 3.1
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
16.7
± 4.2
Activity Tracker-assessed Average Daily Step Counts (Change Scores)Secondary· 3 months
Change scores will be calculated as compared to average daily step count pre-randomization.
Group
Value
95% CI
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
-1445.8
± 5984.0
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
5617.2
± 5963.4
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
42.02
± 448.3
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
4.8
± 4.5
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
4.7
± 1.2
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
4.7
± 3.5
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
5.3
± 1.5
PROMIS Global Health Short Form 10Secondary· 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
PROMIS physical health
Group
Value
95% CI
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
40.5
± 5.2
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
44.3
± 5.8
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
37.4
± 9.3
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
38.2
± 3.8
PROMIS mental health
Group
Value
95% CI
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
47.8
± 5.4
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
50.9
± 5.1
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
55.3
± 4.2
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
38.6
± 7.3
Average Morphine Equivalent Daily DoseSecondary· 3 months
Self-reported average morphine equivalent daily dose over the past 3 days.
Group
Value
95% CI
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
0
± 0
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
0
± 0
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
0
± 0
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
6.7
± 5.8
Global Perceived Effect (How Back Pain Has Changed Since Baseline)Secondary· 3 months
7-point Likert scale where 3 represents 'complete recovery', 0 represents 'not changed', and -3 represents 'become worse than ever'
Group
Value
95% CI
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
0.3
± 1.7
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
0.7
± 0.6
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
0.7
± 1.2
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
0
± 0
Expected Low Back Pain Intensity (0-10 Numerical Pain Rating Scale) if Not Using Pain MedicationsSecondary· 3 months
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07526012 — Comparative Effects Of Post Isometric Relaxation Versus Active Isolated Stretch In Patients With Piriformis Syndrome
· NA
· recruiting
NCT07535047 — Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain
· NA
· recruiting
NCT07463729 — Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome
· NA
· recruiting
NCT07250568 — Office Program Effects on Pain, Posture, Muscle Physiology, Stress, Ergonomics, and Quality of Life in LBP Workers
· NA
· recruiting
NCT07467070 — Effectiveness of Pilates on Postural Correction, Core Strength and Flexibility in Younger Individuals With Non-specific
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 5 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03520387.