Table 2.

Primary Outcomes Over Timea

Outcome
Treatment GroupLow Back Pain IntensityBack-Related DisabilityPain Impact
nMean95% CIPMean95% CIPMean95% CIP
Overall Analysis
 Control2015.925.68-6.170.4614.8113.99-15.620.3631.2230.00-32.430.13
 LTOT2016.065.80-6.3215.3214.55-16.0932.5131.33-33.70
Analysis for Continuous Duration of LTOT
 Control2015.925.68-6.170.5614.8114.00-15.620.8831.2230.00-32.430.43
 LTOT (months)
  3435.825.18-6.4515.6814.00-17.3731.3828.49-34.28
  6236.405.53-7.2815.6913.32-18.0633.5530.12-36.99
  9165.604.75-6.4515.1711.98-18.3631.4826.74-36.22
  121196.135.82-6.4515.1614.19-16.1232.8331.39-34.26
Analysis for Opioid Dose Response Based on Number of Quarters Used
 Control2015.925.68-6.170.7314.8114.00-15.620.8131.2230.00-32.430.50
 LTOT (quarters)
  1255.644.75-6.5315.6013.72-17.4930.9727.83-34.11
  2236.275.32-7.2114.9412.26-17.6232.9528.59-37.31
  3345.915.31-6.5015.9914.00-17.9932.0929.04-35.15
  41196.135.81-6.4515.1614.19-16.1232.8331.39-34.26
Analysis for Opioid Dose Response Based on Baseline MME Dosage
 Control2015.925.68-6.170.8314.8113.99-15.620.4031.2230.00-32.430.47
 LTOT (MMEs)
  ≤301006.095.70-6.4814.8213.69-15.9632.2730.59-33.96
  >30 to <50666.105.66-6.5315.9814.77-17.1932.9330.95-34.90
  ≥50355.905.33-6.4715.5113.59-17.4332.4229.42-35.42
Analysis for Continuous Opioid Use or Abstinence for 12 Months
 Control1325.585.27-5.890.0213.7612.75-14.780.0529.5628.08-31.030.002
 LTOT (MMEs)1196.135.81-6.4515.1614.19-16.1232.8331.39-34.26
  • Abbreviations: LTOT, long-term opioid therapy; CI, confidence interval; MME, morphine milligram equivalent.

  • aPain intensity was measured with a numerical rating scale (0-10). Back-related disability was measured with the Roland-Morris Disability Questionnaire (0-24). Pain impact was measured using low back pain intensity and the physical function and pain interference scales of the Patient-Reported Outcomes Measurement Information System (8-50). Higher scores represent worse outcomes on each measure. Results were computed using generalized estimating equations. Table entries represent mean results and P values for the observations reported from 3 months through 12 months, following determination of treatment group membership and participant matching.