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.
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;
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;
Sequential
Pain EASE
Other interventionThe 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
Procedure/SurgeryFindings 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
Other interventionCCAM 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)
BehavioralParticipants 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)
Procedure/SurgeryAfter 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
Procedure/SurgeryThe 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.
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Treatment groupsSee each treatment group below.
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.
Serious Adverse Events
Attributable and possibly attributable serious adverse events
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.
Patient Health Questionnaire-9 (PHQ-9)
This is a tool to measure comorbid depression. This scale is frequently used in VA settings, has been well validated, and is a quick self-administered questionnaire. \- Possible range for PHQ-9 is 0-27. Higher scores indicate more severe depression. 0-4: None/Minimal depression, 5-9: Mild depression, 10-14: Moderate depression, 15-19: Moderately severe depression, 20-27: Severe depression.
Numeric Rating Scale (NRS)
Possible range of NRS is 0 to 10 with higher scores reflecting greater perceived pain.
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