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Identification of indirect effects in a cognitive patient education (COPE) intervention for low back pain [with consumer summary]
Mansell G, Storheim K, Lochting I, Werner EL, Grotle M
Physical Therapy 2017 Dec;97(12):1138-1146
clinical trial
2/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Many interventions for the treatment of low back pain exist, but the mechanisms through which such treatments work are not always clear. This situation is especially true for biopsychosocial interventions that incorporate several different components and methods of delivery. OBJECTIVE: The study objective was to examine the indirect effects of the cognitive patient education (COPE) intervention via illness perceptions, back pain myths, and pain catastrophizing on disability outcome. DESIGN: This study was a secondary analysis of the COPE randomized controlled trial. METHODS: Mediation analysis techniques were employed to examine the indirect effects of the COPE intervention via residualized change (baseline minus posttreatment) in the 3 variables hypothesized to be targeted by the COPE intervention on posttreatment disability outcome. Pain intensity at baseline, pain duration, clinician type, and a treatment-mediator interaction term were controlled for in the analysis. RESULTS: Preliminary analyses confirmed that changes in pain catastrophizing and illness perceptions (not back pain myths) were related to both allocation to the intervention arm and posttreatment disability score. The treatment exerted statistically significant indirect effects via changes in illness perceptions and pain catastrophizing on posttreatment disability score (illness perceptions standardized indirect effect 0.09 (95% CI 0.03 to 0.16); pain catastrophizing standardized indirect effect 0.05 (95% CI 0.01 to 0.12)). However, the inclusion of an interaction term led to the indirect effects being significantly reduced, with the effects no longer being statistically significant. LIMITATIONS: This study presents a secondary analysis of variables not identified a priori as being potentially important treatment targets; other, unmeasured factors could also be important in explaining treatment effects. CONCLUSIONS: The finding that small indirect effects of the COPE intervention via changes in illness perceptions and pain catastrophizing on posttreatment disability could be estimated indicates that these variables may be viable treatment targets for biopsychosocial interventions; however, this finding must be viewed in light of the adjusted analyses, which showed that the indirect effects were significantly reduced through the inclusion of a treatment-mediator interaction term.

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