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

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Procedure, Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

∙ 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 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.

Locations
United States
Arizona
Phoenix VA Health Care System, Phoenix, AZ
RECRUITING
Phoenix
California
VA Loma Linda Healthcare System, Loma Linda, CA
RECRUITING
Loma Linda
VA Long Beach Healthcare System, Long Beach, CA
RECRUITING
Long Beach
VA Palo Alto Health Care System, Palo Alto, CA
RECRUITING
Palo Alto
Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO
WITHDRAWN
Aurora
Florida
Bay Pines VA Healthcare System, Pay Pines, FL
TERMINATED
Bay Pines
Orlando VA Medical Center, Orlando, FL
RECRUITING
Orlando
Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
RECRUITING
Decatur
Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
RECRUITING
Indianapolis
Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
RECRUITING
Boston
Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
TERMINATED
Baltimore
Missouri
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
RECRUITING
St Louis
North Carolina
Asheville VA Medical Center, Asheville, NC
RECRUITING
Asheville
Nevada
VA Southern Nevada Healthcare System, North Las Vegas, NV
TERMINATED
North Las Vegas
Oregon
VA Portland Health Care System, Portland, OR
RECRUITING
Portland
Texas
South Texas Health Care System, San Antonio, TX
RECRUITING
San Antonio
Utah
VA Salt Lake City Health Care System, Salt Lake City, UT
RECRUITING
Salt Lake City
Virginia
Hampton VA Medical Center, Hampton, VA
TERMINATED
Hampton
Hunter Holmes McGuire VA Medical Center, Richmond, VA
TERMINATED
Richmond
Contact Information
Primary
Brandon J Stevenson, MSW BS
Brandon.Stevenson@va.gov
(319) 388-0581
Time Frame
Start Date: 2022-06-13
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 2529
Treatments
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)
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).
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).
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov