Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response

Description

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

Chronic Low Back Pain

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Study Overview

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Study Details

Study overview

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.

CSP #2009 - Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response: The SCEPTER Trial

Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response

Condition
Chronic Low Back Pain
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix VA Health Care System, Phoenix, AZ, Phoenix, Arizona, United States, 85012

Loma Linda

VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda, California, United States, 92357

Long Beach

VA Long Beach Healthcare System, Long Beach, CA, Long Beach, California, United States, 90822

Palo Alto

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States, 94304-1207

Aurora

Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, United States, 80045

Bay Pines

Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines, Florida, United States, 33744-0000

Orlando

Orlando VA Medical Center, Orlando, FL, Orlando, Florida, United States, 32803

Decatur

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia, United States, 30033

Indianapolis

Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis, Indiana, United States, 46202-2803

Baltimore

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, Baltimore, Maryland, United States, 21201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Low back pain
  • 1. present for at least 6 months,
  • 2. present most days or everyday,
  • 3. interferes the most with activities considering all of the places where the patient experiences pain;
  • 2. Pain, Enjoyment, General Activity (PEG) score of 4 or greater;
  • 3. Veteran age 18 years or older, either sex, any racial or ethnic background;
  • 4. Able to comprehend and willing to sign the study informed consent form;
  • 5. Able to attend in-person treatment sessions;
  • 6. Anticipate continuing care at the enrolling VA for the period of the study;
  • 7. Stable access to the internet at home, work, or other location (e.g. mobile phone), and an email address.
  • 1. Currently enrolled in any other interventional study unless exempted by CSP;
  • 2. Acute or chronic illness that would prevent the Veteran from receiving study treatments offered (e.g., uncontrolled hypertension, recent myocardial infarction within the last 6 months, unstable angina, acute congestive heart failure);
  • 3. Neurological impairment related to disease of the spine or other causes preventing participation in any of the treatment modalities under study;
  • 4. Current or recent (last 3 months) treatment involving Cognitive Behavioral Therapy, Spinal manipulation therapy, or Yoga;
  • 5. Current severe alcohol or substance abuse use disorder;
  • 6. Severe psychiatric illness (e.g. current psychosis, current suicidal ideation, or psychiatric illness requiring hospitalization within the last 6 months);
  • 7. Undergoing evaluation for back surgery or planned back surgery;
  • 8. Cognitive or severe hearing or visual impairment preventing participation in treatment options or outcome measure assessments;
  • 9. Pregnancy;
  • 10. Refusal to provide written consent.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

David J Clark, PhD MD, STUDY_CHAIR, VA Palo Alto Health Care System, Palo Alto, CA

Matthew J. Bair, MD MS, STUDY_CHAIR, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Record Dates

2026-06-17