NCT04142177 · VA Office of Research and Development
Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response
(SCEPTER)
What this study 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 randomly assigned, pragmatic, 2-step comparative effectiveness study design.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Low back pain
- present for at least 6 months,
- present most days or everyday,
- interferes the most with activities considering all of the places where the patient experiences pain;
- Pain, Enjoyment, General Activity (PEG) score of 4 or greater;
- Veteran age 18 years or older, either sex, any racial or ethnic background;
- Able to comprehend and willing to sign the study informed consent form;
- Able and willing to attend in-person treatment sessions;
- Anticipate continuing care at the enrolling VA for the period of the study;
- Stable access to the internet at home, work, or other location (e.g. mobile phone), and an email address.
Exclusion criteria
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Currently enrolled in any other interventional study unless exempted by CSP;
- 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);
- Neurological impairment related to disease of the spine or other causes preventing participation in any of the treatment modalities under study;
- Current or recent (last 3 months) treatment involving Cognitive Behavioral Therapy, Spinal manipulation therapy, or Yoga;
- Current severe alcohol or substance abuse use disorder;
- Severe psychiatric illness (e.g. current psychosis, current suicidal ideation, or psychiatric illness requiring hospitalization within the last 6 months);
- Back surgery within the last 6 months, or undergoing evaluation for back surgery or planned back surgery;
- Cognitive or severe hearing or visual impairment preventing participation in treatment options or outcome measure assessments;
Where
- Phoenix, Arizona
- Loma Linda, California
- Long Beach, California
- Palo Alto, California
- Aurora, Colorado
- Bay Pines, Florida
- Orlando, Florida
- Decatur, Georgia
- Indianapolis, Indiana
- Baltimore, Maryland
- Boston, Massachusetts
- St Louis, Missouri
And 7 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations