Low Back PainSELECT LBPNCT03520387
Selecting Effective Combinations of Treatment for Low Back Pain
A study testing Lumbar medial branch nerve radiofrequency ablation (LRFA), Simulated LRFA with targeted steroid injections and AcTIVE-CBT in people with Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lumbar medial branch nerve radiofrequency ablation (LRFA), Simulated LRFA with targeted steroid injections and AcTIVE-CBT
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Combined Treatments to Optimize Functional Recovery in Veterans With Chronic Low Back Pain
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Lumbar medial branch nerve radiofrequency ablation (LRFA), Simulated LRFA with targeted steroid injections, AcTIVE-CBT, TBSCE
- Keywords
- Randomized controlled trial, Chronic pain
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar medial branch nerve radiofrequency ablation (LRFA)Procedure or surgery
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.
Simulated LRFA with targeted steroid injectionsProcedure or surgery
Also called Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves(simulated LRFA), with targeted steroid injections to the medial branch nerves.
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-CBTBehavioural
Also called Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (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.
TBSCEBehavioural
Also called Telephone-based supportive contact and education (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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar medial branch nerve radiofrequency ablation (LRFA) | Experimental | Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves Receives: Procedure: Lumbar medial branch nerve radiofrequency ablation (LRFA) |
| Simulated lumbar radiofrequency ablation (simulated LRFA) | Active comparator | Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves(simulated LRFA), with targeted steroid injections Receives: Procedure: Simulated LRFA with targeted steroid injections |
| AcTIVE-CBT | Experimental | Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT) Receives: Behavioral: AcTIVE-CBT |
| TBSCE | Active comparator | Telephone-based self-directed CBT and education (TBSCE) Receives: Behavioral: TBSCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (8)
Activity Tracker-assessed Average Daily Step Counts (Change Scores)
Change scores will be calculated as compared to average daily step count pre-randomization.
Measured: 3 months
Low Back Pain Intensity (0-10 Numerical Pain Rating Scale)
Higher numerical pain ratings reflect greater pain intensity.
Measured: 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
Measured: 3 months
Average Morphine Equivalent Daily Dose
Self-reported average morphine equivalent daily dose over the past 3 days.
Measured: 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'
Measured: 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.
Measured: 3 months
Participant-reported Satisfaction
5-point Likert scale where 2 represents 'completely satisfied', 0 represents 'neutral', and -2 represents 'completely dissatisfied'
Measured: 3 months
BRFSS Self-reported Physical Activity Per Week
Self-reported activity equivalent minutes per week
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start15 Nov 2018
- Primary completion30 Jun 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Pradeep Suri, MD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520387
- Sponsor's protocol ID
- F2891-P
- Acronym
- SELECT LBP
- Status last verified
- Aug 2021
- First submitted
- 27 Apr 2018
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39902653
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Treatments to Optimize Functional Recovery in Veterans With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03520387
- Acronym / sponsor ID
- SELECT LBP / F2891-P
- Conditions
- Low Back Pain
- Keywords
- Randomized controlled trial, Chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lumbar medial branch nerve radiofrequency ablation (LRFA) | Experimental | Procedure: Lumbar medial branch nerve radiofrequency ablation (LRFA)Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves |
| Simulated lumbar radiofrequency ablation (simulated LRFA) | Active comparator | Procedure: Simulated LRFA with targeted steroid injectionsSimulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves(simulated LRFA), with targeted steroid injections |
| AcTIVE-CBT | Experimental | Behavioral: AcTIVE-CBTActivity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT) |
| TBSCE | Active comparator | Behavioral: TBSCETelephone-based self-directed CBT and education (TBSCE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Lumbar medial branch nerve radiofrequency ablation (LRFA) |
| Simulated LRFA with targeted steroid injectionsAlso: Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves(simulated LRFA), with targeted steroid injections to the medial branch nerves.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. | Procedure or surgery | Simulated lumbar radiofrequency ablation (simulated LRFA) |
| AcTIVE-CBTAlso: Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (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. | Behavioural | AcTIVE-CBT |
| TBSCEAlso: Telephone-based supportive contact and education (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. | Behavioural | TBSCE |
Primary outcome
Roland-Morris Disability Questionnaire
Time frame: 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).
8 secondary outcomes
Activity Tracker-assessed Average Daily Step Counts (Change Scores)
Time frame: 3 months
Low Back Pain Intensity (0-10 Numerical Pain Rating Scale)
Time frame: 3 months
PROMIS Global Health Short Form 10
Time frame: 3 months
Average Morphine Equivalent Daily Dose
Time frame: 3 months
Global Perceived Effect (How Back Pain Has Changed Since Baseline)
Time frame: 3 months
Expected Low Back Pain Intensity (0-10 Numerical Pain Rating Scale) if Not Using Pain Medications
Time frame: 3 months
Participant-reported Satisfaction
Time frame: 3 months
BRFSS Self-reported Physical Activity Per Week
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39902653Tanus 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pradeep Suri, MD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar medial branch nerve radiofrequency ablation (LRFA), Simulated LRFA with targeted steroid injections and AcTIVE-CBT in people with Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland-Morris Disability Questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03520387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.