Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response

NARecruitingINTERVENTIONAL
Enrollment

2,529

Participants

Timeline

Start Date

June 13, 2022

Primary Completion Date

May 1, 2027

Study Completion Date

December 31, 2027

Conditions
Chronic Low Back Pain
Interventions
OTHER

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.

PROCEDURE

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.

OTHER

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.

BEHAVIORAL

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.

PROCEDURE

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.

PROCEDURE

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.

Trial Locations (19)

21201

TERMINATED

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

23667

TERMINATED

Hampton VA Medical Center, Hampton, VA, Hampton

30033

RECRUITING

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur

32803

RECRUITING

Orlando VA Medical Center, Orlando, FL, Orlando

80045

WITHDRAWN

Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora

85012

RECRUITING

Phoenix VA Health Care System, Phoenix, AZ, Phoenix

89086

TERMINATED

VA Southern Nevada Healthcare System, North Las Vegas, NV, North Las Vegas

90822

RECRUITING

VA Long Beach Healthcare System, Long Beach, CA, Long Beach

92357

RECRUITING

VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda

94304-1207

RECRUITING

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto

33744-0000

TERMINATED

Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines

46202-2803

RECRUITING

Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis

02130-4817

RECRUITING

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

63106-1621

RECRUITING

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

28805-2576

RECRUITING

Asheville VA Medical Center, Asheville, NC, Asheville

97207-2964

RECRUITING

VA Portland Health Care System, Portland, OR, Portland

78229-4404

RECRUITING

South Texas Health Care System, San Antonio, TX, San Antonio

84148-0001

RECRUITING

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

23249-0001

TERMINATED

Hunter Holmes McGuire VA Medical Center, Richmond, VA, Richmond

All Listed Sponsors
lead

VA Office of Research and Development

FED