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• W2031964404 abstract "Purpose: Total joint replacement (TJR) is considered to be one of the most safe, successful, and cost-effective treatments for advanced osteoarthritis (OA). However, residual pain seems to be a major factor of patient’s dissatisfaction following Total Hip Arthroplasty/Total Knee Arthroplasty (THA/TKA). The proportion of patients suffering from unfavourable long-term residual pain is relatively high, proportions ranging from 10 to 34% after knee and 7 to 23% after hip replacement surgery. Changes within the central nervous system are presumably accountable for accessory pain amplification and sensitization. Currently there are studies indicating that a preoperative degree of central sensitisation (CS) is associated with poorer postoperative outcomes and residual pain. Thus, it could be hypothesized that preoperative treatment of CS could enhance postoperative outcomes. Duloxetine, a combined serotonin and norepinephrine reuptake inhibitor (SNRI), has shown to be effective in several chronic pain syndromes, including knee-OA, in which CS is likely one of the underlying pain mechanisms. This study aims to evaluate the postoperative effects of preoperative screening and targeted duloxetine treatment of CS on residual pain, compared to care as usual. Methods: This multi-centre, pragmatic, prospective, open-label, randomized controlled trial (RCT) includes adults which are on the waiting list for primary THA/TKA, with a possible or likely neuropathic pain (NP) phenotype at screening (defined by a score >12 point on the modified-painDETECT questionnaire), hence this will probably identify patients who are more likely to experience CS. Patients will be randomly allocated to the preoperative “duloxetine treatment group” (1 week initiation 30 mg/d, 7 weeks 60 mg/d, 2 weeks taper-phase 30 mg/d) or the “care as usual group” (no specific preoperative intervention). The primary endpoint is the degree of postoperative pain 6 months after THA/TKA, assessed with the pain subscale of the Hip disability/ Knee injury and Osteoarthritis Outcome Score (HOOS/KOOS). Secondary endpoints, at multiple pre- and postoperative time points (up to 12 months postoperative) will be; pain, neuropathic pain (NP), sensitisation (pressure pain thresholds, temporal summation), quality of life and depressive/anxiety symptoms. Furthermore, factors such as perceived satisfaction and arthroplasty related expectations will be analyzed. Based on a minimally clinical important difference of 10 points on the HOOS/KOOS; a total of 118 patients are anticipated to be randomized to detect a clinical relevant difference (80% power, 20% protocol violators and/or dropout included). Results: Data analysis will be conducted on an intention-to-treat basis. In case of the primary endpoint a Student’s t-test (or a non-parametric equivalent in case of a skewed distribution) will be used to determine if there is a difference in pain on the HOOS/KOOS at 6 months postoperative between the two groups. GEE (Generalized Estimating Equation) analysis will be used to determine whether there is a difference on pain between the two groups over time, adjusted for relevant covariates. The same principles will be used to asses the secondary time points. A P-value of < 0.05 is considered statistically significant. Conclusions: This study is, as far as we know, the first pragmatic RCT assessing the postoperative effects of a preoperative targeted duloxetine treatment in OA-patients suffering from a degree of preoperative CS (indicated by a possible or likely NP-phenotype). We believe a pragmatic trial design is valid; hence it mimics the “real life status”, with a “care as usual” control group, as much as possible. Furthermore, the endpoints are, unlike placebo controlled explanatory trials, more focused on the relevancy to everyday life; like hip and knee specific pain, function and quality of life. Knowledge gained with this study can potentially improve postoperative pain relief and rehabilitation after TJR." @default.
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• W2031964404 date "2015-04-01" @default.
• W2031964404 modified "2023-09-27" @default.
• W2031964404 title "The effect of preoperative pain treatment by means of duloxetine on postoperative outcome after total hip or knee arthroplasty: Design of a pragmatic randomized controlled trial" @default.
• W2031964404 doi "https://doi.org/10.1016/j.joca.2015.02.665" @default.
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