Recruiting

Pain TreatmentSequential and Comparative Evaluation of Pain Treatment Effectiveness Response

Sponsor:

VA Office of Research and Development

Code:

NCT04142177

Conditions

Chronic Low Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pain EASE

Tailored exercise

Continued Care and Active Monitoring

Cognitive Behavioral Therapy (CBT)

Spinal Manipulation Therapy (SMT)

Study Details

Brief 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

Chronic Low Back Pain

Study ID

NCT04142177

Start date

Jun 13, 2022

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all the following 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 and willing 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.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

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. Back surgery within the last 6 months, or 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

Study Design

Enrollment

2529 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Internet-based pain self-management program

Internet-based treatment (Step 1 Treatment)

active comparator: Enhanced Physical Therapy

Intervention that combines the internet-based pain self-management program with tailored exercise and physical activity guided by a physical therapist (Step 1 treatment)

placebo comparator: Continued Care and Active Monitoring (CCAM)

CCAM will not be standardized keeping in line with the pragmatic nature of this trial. CCAM may be variable across sites and for individual participants reflecting de facto clinical practice for cLBP. Clinical practice may involve pharmacological and non-pharmacological treatments for cLBP. Current analgesics (including opioids, acetaminophen, NSAIDs, topical analgesics (capsaicin), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, skeletal muscle relaxants, and alpha-2-delta ligands (gabapentin-like drugs)) and non-pharmacological treatments may be continued by participants. CCAM participants will be encouraged to discuss pain problems with their treating physician, but not begin new treatments if possible. Patients will specifically be discouraged from starting CBT, chiropractic, or yoga. Other than this, there will be no attempt by study personnel to influence pain management (Step 1 Treatment)

active comparator: Cognitive Behavioral Therapy (CBT)

active comparator: Spinal Manipulation Therapy (SMT)

After examination by a qualified Doctor of Chiropractic (DC), a SMT intervention consisting of up to 10 sessions over 3 months will be designed focusing on spinal manipulation and/or mobilization of the lower thoracic, lumbar and/or sacroiliac joints. Adjunctive use of myofascial and/or stretching techniques are allowed as they are commonly used along with SMT, and can be considered a standard accompaniment to SMT (Step 2 Treatment).

active comparator: Yoga

The Yoga for Veterans with cLBP program consists of up to 10 weekly, 60-minute instructor-led sessions along with 15-20 minutes of yoga practiced at home each non-session day. The initial session is 75 minutes (15 minutes longer than the other sessions). The yoga program can be considered classical hatha yoga with influences from Iyengar and Viniyoga yoga. These styles emphasize modifications and adaptations including the use of props such as straps and blocks to minimize the risk of injury and make the poses accessible to people with health problems and limitations (Iyengar, 1979). The instructor leads participants through a series of 23 yoga poses (32 total variations) at a slow-moderate pace (Step 2 Treatment).

Interventions

Pain EASE

The internet-based pain self-management program consists of open access to the Pain EASE program (Pain E-health for Activity, Skills, and Education) for the duration of participation in the trial. Pain EASE has 10 pain coping skill modules: pain education, setting personal goals, planning meaningful activities, physical activity (stretching, body mechanics, and a pedometer-based walking program), relaxation, developing healthy thinking patterns, pacing and problem-solving, improving sleep, effective communication, and future planning.

Tailored exercise

Findings from the initial examination and the Keele STarT Back Screening Tool (Hill, et al., 2011) will be used by the physical therapist to guide and tailor the intervention to individual participants which will involve up to 8 treatment sessions with ongoing home exercise. For most participants, exercise and physical activity will focus on walking in addition to motor control and stabilization exercises for the low back with flexibility exercises when lumbar spine stiffness is present.

Continued Care and Active Monitoring

Cognitive Behavioral Therapy (CBT)

Participants randomized to CBT in Step 2 will receive treatment with a trained therapist using the VA's CBT-chronic pain (CBT-CP) protocol involving one planning session and 9 treatment sessions (10 total) over 3 months. The VA's CBT-CP protocol consists of 11 core CBT-CP modules that can be completed in up to 10 sessions. Weekly, individual sessions of 45-50 minutes are recommended, although it is recognized that bi-weekly or other arrangements are often made to fit practical needs.

Spinal Manipulation Therapy (SMT)

Yoga

Primary outcome measure

Brief Pain Inventory (BPI) Interference scale [ Time Frame: 3 months post-treatment ]

Central Contacts and Locations

Central contacts

Brandon J Stevenson, MSW BS

(319) 388-0581 Brandon.Stevenson@va.gov

Locations

Phoenix VA Health Care System, Phoenix, AZ

Recruiting

Phoenix, Arizona, United States, 85012

Contacts

Aram Mardian, MD

602-277-5551

VA Loma Linda Healthcare System, Loma Linda, CA

Recruiting

Loma Linda, California, United States, 92357-1000

Contacts

Thomas Edell, MD

909-801-5127

VA Long Beach Healthcare System, Long Beach, CA

Recruiting

Long Beach, California, United States, 90822

Contacts

Douglas Priestley, MD

714-914-3853

VA Palo Alto Health Care System, Palo Alto, CA

Recruiting

Palo Alto, California, United States, 94304-1207

Contacts

Mitchell J Wong, MD

650-493-5000 Mitchell.Wong@va.gov

Orlando VA Healthcare System, Orlando, FL

Recruiting

Orlando, Florida, United States, 32827

Contacts

Charles Penza, PhD

407-631-3190

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Jerry Kalangara, MD

404-329-2201

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Recruiting

Indianapolis, Indiana, United States, 46202-2884

Contacts

David Haggstrom, MD

317-988-2067

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

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Eduardo Lopez, MD

857-203-6500

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

Recruiting

St Louis, Missouri, United States, 63106-1621

Contacts

Jason Napuli, DC

314-652-4100

Asheville VA Medical Center, Asheville, NC

Recruiting

Asheville, North Carolina, United States, 28805-2576

Contacts

James Michalets, MD

828-298-7911

VA Portland Health Care System, Portland, OR

Recruiting

Portland, Oregon, United States, 97207-2964

Contacts

Stephanie K Liu, MD

503-220-8262

South Texas Health Care System, San Antonio, TX

Recruiting

San Antonio, Texas, United States, 78229-4404

Contacts

Michelle Trbovich, MD

210-818-4353

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

Recruiting

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

Contacts

Patrick Powers, MD

814-571-1608

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

chronic low back pain
severe low back pain
pain
non-pharmacological treatment
self-management
physical therapy
exercise
yoga
cognitive behavioral therapy
spinal manipulation therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-04.