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Combined digital interventions for pain reduction in patients undergoing knee replacement: a randomized clinical trial [with consumer summary]
Duong V, Robbins SR, Dennis S, Venkatesha V, Ferreira ML, Hunter DJ
JAMA Network Open 2023 Sep;6(9):e2333172
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

IMPORTANCE: Digital technology represents an opportunity to improve outcomes following total knee replacement (TKR). Digitally delivered interventions have been shown to be similar to face-to-face interventions and to increase participation levels in people with osteoarthritis. OBJECTIVE: To assess the effect of a digital technology package in reducing pain compared with usual care following TKR. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial recruited 102 adults after they received TKR in 3 rehabilitation hospitals in Sydney, Australia, between June 2020 and July 2021. Interventions: All participants underwent usual care. In addition to usual care, 51 participants received a digital technology package consisting of an exercise app, fitness tracker, and online health coaching. In the usual care group, 51 participants received a fitness tracker but with all notifications turned off and goals for step count, sleep, and active hours removed. Participants were followed up for 12 months (June 2021 to July 2022). MAIN OUTCOME AND MEASURES: The primary outcome was mean knee pain during the past week assessed using a numerical rating scale (range 0 to 10, with 10 indicating worst possible pain) at 3 months. In unadjusted analyses, considered primary and based on multiple imputations, independent t tests were used to compare means between groups. Secondary outcomes, including measures of function, activity participation, and quality of life, were analyzed using a generalized estimating equation model that accounted for repeated measurements. RESULTS: Of 102 participants (mean (SD) age, 67.9 (7.2) years; 68 (67%) female; and 92 (90%) White) randomly assigned to intervention or usual care groups, 47 (92%) in each group completed the 3-month follow up. At 3 months, participants in the intervention group demonstrated small but not clinically meaningful improvements in pain compared with the usual care group in the unadjusted intention-to-treat analysis (mean difference -0.84; 95% CI -1.59 to -0.10; p = 0.03). Secondary outcomes indicated a statistically significant reduction in pain intensity, (mean difference -0.94; 95% CI -1.82 to -0.06), pain disability (mean difference -5.42; 95% CI -10.00 to -0.83), and sedentary behavior (mean difference -9.76; 95% CI -19.17 to -0.34) favoring the intervention from baseline to 3, 6, and 12 months. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, a combined digital technology program provided small but not clinically meaningful improvements in pain at 3 months and other longer-term favorable outcomes following TKR compared with usual care. Future studies should tailor digital interventions based on participants' abilities and preferences to ensure that the intervention is appropriate and fosters long-term self-management. TRIAL REGISTRATION: Identifier: ACTRN12618001448235.

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