Sensitivity Analyses for Primary Outcomes over Timea
Outcome | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Low Back Pain Intensity | Back-Related Disability | Pain Impact | ||||||||
Treatment Group | n | Mean | 95% CI | P | Mean | 95% CI | P | Mean | 95% CI | P |
Overall Analysis | ||||||||||
Control | 201 | 5.99 | 5.74-6.24 | 0.48 | 14.88 | 14.09-15.67 | 0.38 | 31.38 | 30.19-32.57 | 0.14 |
LTOT | 201 | 6.11 | 5.86-6.36 | 15.38 | 14.59-16.17 | 32.64 | 31.45-33.83 | |||
Analysis for Continuous Duration of LTOT | ||||||||||
Control | 201 | 5.99 | 5.74-6.24 | 0.57 | 14.88 | 14.09-15.67 | 0.85 | 31.38 | 30.18-32.57 | 0.55 |
LTOT (months) | ||||||||||
3 | 43 | 5.89 | 5.32-6.46 | 15.78 | 14.05-17.51 | 31.73 | 29.12-34.34 | |||
6 | 23 | 6.52 | 5.78-7.25 | 15.83 | 13.50-18.17 | 33.50 | 29.97-37.03 | |||
9 | 16 | 5.76 | 4.88-6.65 | 15.55 | 12.75-18.35 | 32.01 | 27.79-36.23 | |||
12 | 119 | 6.15 | 5.83-6.48 | 15.13 | 14.11-16.16 | 32.88 | 31.33-34.43 | |||
Analysis for Opioid Dose Response Based on Number of Quarters Used | ||||||||||
Control | 201 | 5.99 | 5.74-6.24 | 0.68 | 14.88 | 14.09-15.67 | 0.78 | 31.38 | 30.18-32.57 | 0.60 |
LTOT (quarters) | ||||||||||
1 | 25 | 5.67 | 4.89-6.44 | 15.84 | 13.55-18.13 | 31.48 | 28.02-34.94 | |||
2 | 23 | 6.36 | 5.62-7.10 | 15.12 | 12.79-17.46 | 33.02 | 29.49-36.56 | |||
3 | 34 | 6.08 | 5.47-6.69 | 16.11 | 14.19-18.02 | 32.35 | 29.46-35.25 | |||
4 | 119 | 6.16 | 5.83-6.48 | 15.13 | 14.11-16.16 | 32.88 | 31.33-34.43 | |||
Analysis for Opioid Dose Response Based on Baseline MME Dosage | ||||||||||
Control | 201 | 5.99 | 5.74-6.24 | 0.89 | 14.88 | 14.09-15.67 | 0.44 | 31.38 | 30.19-32.57 | 0.45 |
LTOT (MMEs) | ||||||||||
≤30 | 100 | 6.14 | 5.78-6.49 | 14.85 | 13.74-15.97 | 32.26 | 30.57-33.95 | |||
>30 to <50 | 66 | 6.13 | 5.70-6.57 | 16.10 | 14.72-17.47 | 33.18 | 31.10-35.27 | |||
≥50 | 35 | 6.01 | 5.41-6.62 | 15.54 | 13.65-17.43 | 32.72 | 29.85-35.58 | |||
Analysis for Continuous Opioid Use or Abstinence for 12 Months | ||||||||||
Control | 132 | 5.65 | 5.35-5.95 | 0.03 | 13.86 | 12.90-14.83 | 0.08 | 29.68 | 28.25-31.10 | 0.003 |
LTOT | 119 | 6.14 | 5.82-6.46 | 15.12 | 14.11-16.14 | 32.87 | 31.37-34.37 |
Abbreviations: LTOT, long-term opioid therapy; MME, morphine milligram equivalent; CI, confidence interval.
↵Notes: 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 values represent worse outcomes on each measure. Results were computed using linear mixed methods. 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.