2,529
Participants
Start Date
June 13, 2022
Primary Completion Date
May 1, 2027
Study Completion Date
December 31, 2027
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
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.
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)
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.
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.
TERMINATED
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, Baltimore
TERMINATED
Hampton VA Medical Center, Hampton, VA, Hampton
RECRUITING
Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur
RECRUITING
Orlando VA Medical Center, Orlando, FL, Orlando
WITHDRAWN
Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora
RECRUITING
Phoenix VA Health Care System, Phoenix, AZ, Phoenix
TERMINATED
VA Southern Nevada Healthcare System, North Las Vegas, NV, North Las Vegas
RECRUITING
VA Long Beach Healthcare System, Long Beach, CA, Long Beach
RECRUITING
VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda
RECRUITING
VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto
TERMINATED
Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines
RECRUITING
Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis
RECRUITING
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston
RECRUITING
St. Louis VA Medical Center John Cochran Division, St. Louis, MO, St Louis
RECRUITING
Asheville VA Medical Center, Asheville, NC, Asheville
RECRUITING
VA Portland Health Care System, Portland, OR, Portland
RECRUITING
South Texas Health Care System, San Antonio, TX, San Antonio
RECRUITING
VA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City
TERMINATED
Hunter Holmes McGuire VA Medical Center, Richmond, VA, Richmond
VA Office of Research and Development
FED