Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response

NCT04142177 | Recruiting DMC

• 1 other identifier: 2009
• Study Type: interventional
• Target: 2,529
• Locations: 1 country
• Sites: 19

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

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

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI) Interference scale

  Pain interference will be assessed with the Brief Pain Inventory (BPI) Interference subscale, a validated measure that rates pain interference of pain on 7 items (mood, physical activity, work, social activity, relations, sleep, and life enjoyment). BPI scores range 0 to 10, with higher scores representing worse pain interference, and a 1-point change considered clinically important. Linear mixed effects models will be used to compare the primary outcome (change in pain interference score from pre-treatment to 3 months after treatment) between Step 1 treatments in all participants and between Step 2 treatments in Step 1 non-responders. The mixed effects model will include treatment and study site as fixed effects, and therapist as random effects. For the comparison of Step 1 treatments, the model will also include a fixed effect for opioid use at study entry.

  3 months post-treatment

Secondary Outcomes (15)

• Serious Adverse Events

  3, 6, 9, and 12 months post-treatment

• Brief Pain Inventory (BPI) Interference scale

  6, 9, and 12 months post-treatment

• Patient Health Questionnaire-9 (PHQ-9)

  3, 6, 9, and 12 months post-treatment

• Numeric Rating Scale (NRS)

  3, 6, 9, and 12 months post-treatment

• Roland-Morris Disability Questionnaire (RMDQ)

  3, 6, 9, and 12 months post-treatment

Study Arms (6)

Internet-based pain self-management program

ACTIVE COMPARATOR

Internet-based treatment (Step 1 Treatment)

Other: Pain EASE

Enhanced Physical Therapy

ACTIVE COMPARATOR

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

Other: Pain EASE; Procedure: Tailored exercise

Continued Care and Active Monitoring (CCAM)

PLACEBO COMPARATOR

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)

Other: Continued Care and Active Monitoring

Cognitive Behavioral Therapy (CBT)

ACTIVE COMPARATOR

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 (Step 2 Treatment).

Behavioral: Cognitive Behavioral Therapy (CBT)

Spinal Manipulation Therapy (SMT)

ACTIVE COMPARATOR

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).

Procedure: Spinal Manipulation Therapy (SMT)

Yoga

ACTIVE COMPARATOR

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).

Procedure: Yoga

Interventions

Pain EASE OTHER

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.

Enhanced Physical Therapy; Internet-based pain self-management program

Tailored exercise PROCEDURE

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.

Enhanced Physical Therapy

Continued Care and Active Monitoring OTHER

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.

Continued Care and Active Monitoring (CCAM)

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

Cognitive Behavioral Therapy (CBT)

Spinal Manipulation Therapy (SMT) PROCEDURE

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.

Spinal Manipulation Therapy (SMT)

Yoga PROCEDURE

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.

Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Pregnancy

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (19)

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, 85012, United States

RECRUITING

VA Loma Linda Healthcare System, Loma Linda, CA

Loma Linda, California, 92357-1000, United States

RECRUITING

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

RECRUITING

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

RECRUITING

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

WITHDRAWN

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida, 33744-0000, United States

TERMINATED

Orlando VA Healthcare System, Orlando, FL

Orlando, Florida, 32827, United States

RECRUITING

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

RECRUITING

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

RECRUITING

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

Baltimore, Maryland, 21201, United States

TERMINATED

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

Boston, Massachusetts, 02130-4817, United States

RECRUITING

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

St Louis, Missouri, 63106-1621, United States

RECRUITING

VA Southern Nevada Healthcare System, North Las Vegas, NV

North Las Vegas, Nevada, 89086, United States

TERMINATED

Asheville VA Medical Center, Asheville, NC

Asheville, North Carolina, 28805-2576, United States

RECRUITING

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

RECRUITING

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229-4404, United States

RECRUITING

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

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

RECRUITING

Hampton VA Medical Center, Hampton, VA

Hampton, Virginia, 23667, United States

TERMINATED

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

TERMINATED

Related Publications (1)

• Clark JD, Bair MJ, Belitskaya-Levy I, Fitzsimmons C, Zehm LM, Dougherty PE, Giannitrapani KF, Groessl EJ, Higgins DM, Murphy JL, Riddle DL, Huang GD, Shih MC. Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER), a pragmatic trial for conservative chronic low back pain treatment. Contemp Clin Trials. 2023 Feb;125:107041. doi: 10.1016/j.cct.2022.107041. Epub 2022 Dec 7.

  PMID: 36496154 DERIVED

MeSH Terms

Conditions

Low Back Pain; Pain; Motor Activity

Interventions

pain ease refrigerant; Cognitive Behavioral Therapy; Yoga

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• David J Clark, PhD MD

  VA Palo Alto Health Care System, Palo Alto, CA

  STUDY CHAIR

• Matthew J. Bair, MD MS

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  STUDY CHAIR

Central Study Contacts

Brandon J Stevenson, MSW BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blinded study. The participants, Local Site Investigators (LSIs) and Site Coordinators will have the information on participant treatment assignment. Centralized Outcome Assessors (COAs) who collect primary and secondary outcome measures over the phone will be blinded to treatment assignment. The study team who manage the day-to-day study operations (including Study Chairs, National Study Coordinator, and study team members at Cooperative Studies Program Coordinating Centers \[CSPCC\] and Clinical Research Pharmacy Coordinating Centers \[CRPCC\] may have information on specific individual participant treatment assignment only when the information is needed to perform their work.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: sequential randomized, pragmatic, 2-step comparative effectiveness study design

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: June 13, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)