Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response
NCT04142177 · View on ClinicalTrials.gov ↗
Study Summary
VETERANS ONLY. Chronic low back pain (cLBP) is common. Most Americans will have at least one episode of low back pain in their lifetimes. Approximately 50% of all US Veterans have chronic pain, and CLBP is the most common type of pain in this population. This study will use a sequential randomized, pragmatic, 2-step comparative effectiveness study design. The main goal is to identify the best approach for treating cLBP using commonly recommended non-surgical and non-pharmacological options. The first step compares continued care and active monitoring (CCAM) to internet-based pain self-management (Pain EASE) and an enhanced physical therapy intervention that combines Pain EASE with tailored exercise and physical activity. Patients who do not have a significant decrease in pain interference (a functional outcome) in Step 1 and those desiring additional treatment will be randomized in Step 2 to yoga, spinal manipulation therapy (SMT), or therapist-delivered cognitive behavioral therapy (CBT). Participants proceeding to randomization in Step 2 will be allowed to exclude up to one of the three Step 2 treatments based on their preferences. The investigators' primary hypothesis for the first treatment step is that an enhanced physical therapy intervention that combines pain self-management education with a tailored exercise program will reduce pain interference greater than internet-based pain self-management alone or CCAM in Veterans with cLBP. The primary outcome is change in pain interference at 3 months, measured using the Brief Pain Inventory (BPI) pain interference subscale. Study participants will be followed for one year after initiation of their final study treatments to assess the durability of treatment effects. The study plans to randomize 2529 patients across 20 centers.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy (CBT)
- OTHER Pain EASE
- PROCEDURE Tailored exercise
- OTHER Continued Care and Active Monitoring
- PROCEDURE Spinal Manipulation Therapy (SMT)
Study Locations (19)
California
- VA Loma Linda Healthcare System, Loma Linda, CA — Loma Linda
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto
Florida
- Bay Pines VA Healthcare System, Pay Pines, FL — Bay Pines
- Orlando VA Medical Center, Orlando, FL — Orlando
Virginia
- Hampton VA Medical Center, Hampton, VA — Hampton
- Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond
Arizona
- Phoenix VA Health Care System, Phoenix, AZ — Phoenix
Colorado
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur
Indiana
- Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis
Maryland
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,529 participants |
| Start Date | 2022-06-13 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04142177
The ClinicalTrials.gov registry entry for NCT04142177 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,529 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Low Back Pain appearing as the primary indexed condition, and to 5 interventions — of which Cognitive Behavioral Therapy (CBT) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04142177 reports 19 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04142177 about?
NCT04142177 is a clinical study titled "Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response". VETERANS ONLY. Chronic low back pain (cLBP) is common. Most Americans will have at least one episode of low back pain in their lifetimes. Approximately 50% of all US Veterans have chronic pain, and CLBP is the most common type of pain in this population. This study will use a sequential randomized, ...
What is the current status of trial NCT04142177?
This trial is currently recruiting. It is a NA study. The enrollment target is 2,529 participants. The study started on 2022-06-13. Estimated completion is 2027-12-31.
What conditions does trial NCT04142177 study?
This clinical trial studies the following conditions: Chronic Low Back Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04142177?
The interventions under investigation include: Cognitive Behavioral Therapy (CBT) (BEHAVIORAL), Pain EASE (OTHER), Tailored exercise (PROCEDURE), Continued Care and Active Monitoring (OTHER), Spinal Manipulation Therapy (SMT) (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04142177?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04142177 being conducted?
This trial has 19 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.