Primary Outcomes Over Timea
Outcome | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Treatment Group | Low Back Pain Intensity | Back-Related Disability | Pain Impact | |||||||
n | Mean | 95% CI | P | Mean | 95% CI | P | Mean | 95% CI | P | |
Overall Analysis | ||||||||||
Control | 201 | 5.92 | 5.68-6.17 | 0.46 | 14.81 | 13.99-15.62 | 0.36 | 31.22 | 30.00-32.43 | 0.13 |
LTOT | 201 | 6.06 | 5.80-6.32 | 15.32 | 14.55-16.09 | 32.51 | 31.33-33.70 | |||
Analysis for Continuous Duration of LTOT | ||||||||||
Control | 201 | 5.92 | 5.68-6.17 | 0.56 | 14.81 | 14.00-15.62 | 0.88 | 31.22 | 30.00-32.43 | 0.43 |
LTOT (months) | ||||||||||
3 | 43 | 5.82 | 5.18-6.45 | 15.68 | 14.00-17.37 | 31.38 | 28.49-34.28 | |||
6 | 23 | 6.40 | 5.53-7.28 | 15.69 | 13.32-18.06 | 33.55 | 30.12-36.99 | |||
9 | 16 | 5.60 | 4.75-6.45 | 15.17 | 11.98-18.36 | 31.48 | 26.74-36.22 | |||
12 | 119 | 6.13 | 5.82-6.45 | 15.16 | 14.19-16.12 | 32.83 | 31.39-34.26 | |||
Analysis for Opioid Dose Response Based on Number of Quarters Used | ||||||||||
Control | 201 | 5.92 | 5.68-6.17 | 0.73 | 14.81 | 14.00-15.62 | 0.81 | 31.22 | 30.00-32.43 | 0.50 |
LTOT (quarters) | ||||||||||
1 | 25 | 5.64 | 4.75-6.53 | 15.60 | 13.72-17.49 | 30.97 | 27.83-34.11 | |||
2 | 23 | 6.27 | 5.32-7.21 | 14.94 | 12.26-17.62 | 32.95 | 28.59-37.31 | |||
3 | 34 | 5.91 | 5.31-6.50 | 15.99 | 14.00-17.99 | 32.09 | 29.04-35.15 | |||
4 | 119 | 6.13 | 5.81-6.45 | 15.16 | 14.19-16.12 | 32.83 | 31.39-34.26 | |||
Analysis for Opioid Dose Response Based on Baseline MME Dosage | ||||||||||
Control | 201 | 5.92 | 5.68-6.17 | 0.83 | 14.81 | 13.99-15.62 | 0.40 | 31.22 | 30.00-32.43 | 0.47 |
LTOT (MMEs) | ||||||||||
≤30 | 100 | 6.09 | 5.70-6.48 | 14.82 | 13.69-15.96 | 32.27 | 30.59-33.96 | |||
>30 to <50 | 66 | 6.10 | 5.66-6.53 | 15.98 | 14.77-17.19 | 32.93 | 30.95-34.90 | |||
≥50 | 35 | 5.90 | 5.33-6.47 | 15.51 | 13.59-17.43 | 32.42 | 29.42-35.42 | |||
Analysis for Continuous Opioid Use or Abstinence for 12 Months | ||||||||||
Control | 132 | 5.58 | 5.27-5.89 | 0.02 | 13.76 | 12.75-14.78 | 0.05 | 29.56 | 28.08-31.03 | 0.002 |
LTOT (MMEs) | 119 | 6.13 | 5.81-6.45 | 15.16 | 14.19-16.12 | 32.83 | 31.39-34.26 |
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.