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Table 3 (Revised). Results of Analysis Comparing Outcomes Between Treatment Groupsa
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No significant interaction or main effects of group were found for the primary or secondary outcome measures (Tab. 3). There was a significant main effect (P<.05) of time for the NPRS [Numeric Pain Rating Scale], PSFS [Patient-Specific Functional Scale], NDI [Neck Disability Index], and body diagram, indicating there were significant improvements in pain, function, disability, and symptom distribution regardless of group assignment (MTEX [sham intermittent cervical traction] versus MTEXTraction [intermittent cervical traction]) from baseline to the 4-week follow-up. The adjusted effect size at 4 weeks from the mixed-models analysis for each of the primary outcomes was small (NDI=1.5, 95% confidence interval [CI]=–3.8 to 6.8; PSFS=0.3, 95% CI=–1.2 to 1.8; and NPRS=0.5, 95% CI=–1.0 to 2.1).
Discussion (paragraph 2)
Although there were no significant differences between groups with any of the outcome measures, the estimates of the treatment effects were imprecise, and this uncertainty needs to be considered when interpreting the trial results. At the 2-week follow-up, the upper boundary of the adjusted 95% CI for the NDI was 7.0 (Tab. 3). This value meets the threshold for meaningful clinically important change of the NDI (7.0), suggesting that we cannot exclude the possibility of harm in the MTEXTraction group relative to the MTEX group. Similarly, at the 4-week follow-up, the upper boundaries of the adjusted and unadjusted 95% CIs for the NPRS were 2.1 and 1.7, respectively (Tab. 3). These values exceed the threshold for meaningful clinically important change of the NPRS (1.3) and also indicate that we cannot exclude the possibility of harm in the MTEXTraction group. In addition, at the 2-week follow-up, the lower boundaries of the adjusted and unadjusted 95% CIs for the NPRS were –2.1 and –1.6, respectively (Tab. 3). These values, which are greater than the threshold for minimal clinically important difference (MCID), suggest that we cannot exclude the possibility of a clinically important benefit of the MTEXTraction group relative to the MTEX group for the NPRS variable at this specific time point.
References
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