Selecting Effective Combinations of Treatment for Low Back Pain
SELECT LBP
Combined Treatments to Optimize Functional Recovery in Veterans With Chronic Low Back Pain
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable low-back-pain
Started Nov 2018
Typical duration for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2018
CompletedFirst Posted
Study publicly available on registry
May 9, 2018
CompletedStudy Start
First participant enrolled
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2020
CompletedResults Posted
Study results publicly available
September 5, 2021
CompletedSeptember 5, 2021
August 1, 2021
1.6 years
April 27, 2018
June 14, 2021
August 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Activity Tracker-assessed Average Daily Step Counts (Change Scores)
3 months
Low Back Pain Intensity (0-10 Numerical Pain Rating Scale)
3 months
PROMIS Global Health Short Form 10
3 months
Average Morphine Equivalent Daily Dose
3 months
Global Perceived Effect (How Back Pain Has Changed Since Baseline)
3 months
- +3 more secondary outcomes
Study Arms (4)
Lumbar medial branch nerve radiofrequency ablation (LRFA)
EXPERIMENTALRadiofrequency ablation of the dorsal rami of the lumbar spinal nerves
Simulated lumbar radiofrequency ablation (simulated LRFA)
ACTIVE COMPARATORSimulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves(simulated LRFA), with targeted steroid injections
AcTIVE-CBT
EXPERIMENTALActivity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT)
TBSCE
ACTIVE COMPARATORTelephone-based self-directed CBT and education (TBSCE)
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108, United States
Related Publications (1)
Tanus AD, Nishio I, Williams R, Friedly J, Soares B, Anderson D, Bambara J, Dawson T, Hsu A, Kim PY, Krashin D, Del Piero L, Korpak A, Timmons A, Suri P. Combining procedural and behavioral treatments for chronic low back pain: A pilot feasibility randomized controlled trial. PM R. 2025 Apr;17(4):431-444. doi: 10.1002/pmrj.13323. Epub 2025 Feb 4.
PMID: 39902653DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pradeep Suri, MD
- Organization
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study Officials
- PRINCIPAL INVESTIGATOR
Pradeep Suri, MD
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Some investigators are not masked, for safety monitoring purposes.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2018
First Posted
May 9, 2018
Study Start
November 15, 2018
Primary Completion
June 30, 2020
Study Completion
August 30, 2020
Last Updated
September 5, 2021
Results First Posted
September 5, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- The investigators will endeavor to share IPD when requested by 6 months after the time of publication of the main study findings and publication of longer-term results of the study, provided that appropriate enterprise-level procedures permit this and are in place at the time of.
- Access Criteria
- The study team and PI will review each request for IPD, with involvement of local administrative officials as appropriate. Requests will be evaluated for criteria including data safety, the purpose of analyses warranting potential risks of transferring data, security of the transfer. An agreement will specify the duration of time for data to be held before being destroyed at the destination site.
Only completely deidentified/anonymized versions of datasets would be shared, provided that appropriate enterprise-level procedures permit this and are in place. Sharing would only take place under a written agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset, including a properly submitted FOIA request. Electronic versions of final data sets will be maintained locally in a secure manner until enterprise-level resources become available for long-term storage.