Selecting Effective Combinations of Treatment for Low Back Pain
CompletedNot applicableNCT03520387
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 tr…
Study details
- Official title
- Combined Treatments to Optimize Functional Recovery in Veterans With Chronic Low Back Pain
- Conditions
- Interventions
- Procedure: Lumbar medial branch nerve radiofrequency ablation (LRFA)
- Procedure: Simulated LRFA with targeted steroid injections
- Behavioral: AcTIVE-CBT
- Behavioral: TBSCE
- Sponsor
- VA Office of Research and Development
- Start date
- 2018-11-15
- Primary completion
- 2020-06-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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) 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03520387