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NCT04142177 · ClinicalTrials.gov registry record · NA

Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response

A NA study of Chronic Low Back Pain, sponsored by VA Office of Research and Development.

Recruiting
Registry status
NA
Development phase
2,529
Enrollment target
19
Study locations

NCT04142177 is a NA study of Chronic Low Back Pain that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 2,529 participants, above the 556-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (355% higher). The trial reports 19 study locations across 15 states.

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The verdict

NCT04142177, a NA study of Chronic Low Back Pain, is actively recruiting participants, sponsored by VA Office of Research and Development.

RECRUITING
Registry status
NA
Development phase
2,529 participants
Enrollment target
19
Study locations

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

Chronic Low Back Pain

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

FieldValue
Enrollment Target 2,529 participants
Start Date 2022-06-13
Est. Completion 2027-12-31
Phase NA

Sponsor

VA Office of Research and Development

1,668 total trials

Interested in This 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, categorized as NA. The registered enrollment target is 2,529 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 556-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (355% higher). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

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.

NCT04142177 reports 19 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, Virginia.

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.

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).

Who is sponsoring clinical trial NCT04142177?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.