Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04142177

Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response

Led by VA Office of Research and Development · Updated on 2026-05-04

2529

Participants Needed

19

Research Sites

263 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Low back pain present for at least 6 months
  • Low back pain present most days or every day
  • Low back pain interferes most with activities compared to other pain locations
  • Pain, Enjoyment, General Activity (PEG) score of 4 or greater
  • Veteran aged 18 years or older, any sex, any racial or ethnic background
  • Able to understand and willing to sign informed consent
  • Able and willing to attend in-person treatment sessions
  • Expect to continue care at the enrolling VA during the study
  • Stable access to the internet and have an email address
Not Eligible

You will not qualify if you...

  • Currently enrolled in any other interventional study unless exempted
  • Acute or chronic illness preventing receiving study treatments (e.g., uncontrolled hypertension, recent heart attack within 6 months, unstable angina, acute heart failure)
  • Neurological impairment related to spine disease or other causes preventing participation
  • Current or recent (last 3 months) treatment with cognitive behavioral therapy, spinal manipulation therapy, or yoga
  • Current severe alcohol or substance abuse disorder
  • Severe psychiatric illness (e.g., current psychosis, suicidal thoughts, or hospitalization within last 6 months)
  • Back surgery within last 6 months or planned back surgery
  • Cognitive or severe hearing or vision impairment preventing participation
  • Pregnancy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 19 locations

1

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, United States, 85012

Actively Recruiting

2

VA Loma Linda Healthcare System, Loma Linda, CA

Loma Linda, California, United States, 92357-1000

Actively Recruiting

3

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States, 90822

Actively Recruiting

4

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States, 94304-1207

Actively Recruiting

5

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States, 80045

Withdrawn

6

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida, United States, 33744-0000

Terminated

7

Orlando VA Healthcare System, Orlando, FL

Orlando, Florida, United States, 32827

Actively Recruiting

8

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States, 30033-4004

Actively Recruiting

9

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States, 46202-2884

Actively Recruiting

10

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, United States, 21201

Terminated

11

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States, 02130-4817

Actively Recruiting

12

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, United States, 63106-1621

Actively Recruiting

13

VA Southern Nevada Healthcare System, North Las Vegas, NV

North Las Vegas, Nevada, United States, 89086

Terminated

14

Asheville VA Medical Center, Asheville, NC

Asheville, North Carolina, United States, 28805-2576

Actively Recruiting

15

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States, 97207-2964

Actively Recruiting

16

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States, 78229-4404

Actively Recruiting

17

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, United States, 84148-0001

Actively Recruiting

18

Hampton VA Medical Center, Hampton, VA

Hampton, Virginia, United States, 23667

Terminated

19

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States, 23249-0001

Terminated

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Research Team

B

Brandon J Stevenson, MSW BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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