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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE April 27, 2018
First Posted Date  ICMJE May 9, 2018
Last Update Posted Date November 5, 2019
Actual Study Start Date  ICMJE November 15, 2018
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • 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'
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selecting Effective Combinations of Treatment for Low Back Pain
Official Title  ICMJE Combined Treatments to Optimize Functional Recovery in Veterans With Chronic Low Back Pain
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 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.

Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
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.
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • 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.
  • 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.
  • Behavioral: 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).
  • Behavioral: 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)
Study Arms  ICMJE
  • Experimental: Lumbar medial branch nerve radiofrequency ablation (LRFA)
    Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves
    Intervention: Procedure: Lumbar medial branch nerve radiofrequency ablation (LRFA)
  • 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
    Intervention: Procedure: Simulated LRFA with targeted steroid injections
  • Experimental: AcTIVE-CBT
    Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT)
    Intervention: Behavioral: AcTIVE-CBT
  • Active Comparator: TBSCE
    Telephone-based self-directed CBT and education (TBSCE)
    Intervention: Behavioral: TBSCE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 5 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pradeep Suri, MD (206) 314-3256 Pradeep.Suri@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03520387
Other Study ID Numbers  ICMJE F2891-P
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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.
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pradeep Suri, MD VA Puget Sound Health Care System Seattle Division, Seattle, WA
PRS Account VA Office of Research and Development
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP