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

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

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.

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