Abstract：
BACKGROUND: Durable, meaningful symptom responses to intra-articular saline placebo injections are observed in knee osteoarthritis (OA) trials, but it is unclear if these are due to physiological effects.
OBJECTIVE: To perform a prospective comparison of patient-reported outcome responses among participants with knee OA who underwent intra-articular injection of saline-based placebo or sham (dry needle).
METHODS: Randomized controlled trial; Level of evidence, 2.
METHODS: From a 24-week randomized double-blind trial, participants with moderate to severe knee OA received 2-mL intra-articular injections of saline-based placebo (PBO; 99.45% PBS) or sham (dry needle) to the target knee. Least squares mean differences of changes from baseline to week 24 were compared between the PBO and sham groups for the following: pain Numeric Rating Scale; Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and function; and patient global assessment. Bang Blinding Index was used to evaluate all-group blinding on day 1 and week 24.
RESULTS: In total, 116 and 117 participants were randomized to the PBO and sham groups, respectively. Within the full trial population, the mean ± SD age and body mass index were 59.0 ± 8.5 years and 28.97 ± 4.01, respectively. An overall 406 (58.4%) were female, and 394 (57.3%) had Kellgren-Lawrence grade 3 target knee OA. The PBO and sham groups demonstrated clinically meaningful improvements (≥10%) from baseline in all patient-reported outcomes at all time points (ie, weeks 4-24). Mean differences (95% CI) at week 24 between the PBO and sham groups were as follows: pain Numeric Rating Scale, -0.10 (-0.79 to 0.59; P = .78); WOMAC pain, -2.89 (-9.70 to 3.92; P = .40); WOMAC stiffness, -2.37 (-9.37 to 4.63; P = .51); and WOMAC function, -1.39 (-8.06 to 5.29; P = .68). Bang Blinding Index indicated that blinding was maintained.
CONCLUSIONS: PBO and sham groups demonstrated equivalent patient-reported outcomes at all time points through week 24, suggesting that responses attributed to saline were contextual (ie, to the procedure) and not physiological.
BACKGROUND: NCT03122860 (ClinicalTrials.gov identifier).
OBJECTIVE: To perform a prospective comparison of patient-reported outcome responses among participants with knee OA who underwent intra-articular injection of saline-based placebo or sham (dry needle).
METHODS: Randomized controlled trial; Level of evidence, 2.
METHODS: From a 24-week randomized double-blind trial, participants with moderate to severe knee OA received 2-mL intra-articular injections of saline-based placebo (PBO; 99.45% PBS) or sham (dry needle) to the target knee. Least squares mean differences of changes from baseline to week 24 were compared between the PBO and sham groups for the following: pain Numeric Rating Scale; Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and function; and patient global assessment. Bang Blinding Index was used to evaluate all-group blinding on day 1 and week 24.
RESULTS: In total, 116 and 117 participants were randomized to the PBO and sham groups, respectively. Within the full trial population, the mean ± SD age and body mass index were 59.0 ± 8.5 years and 28.97 ± 4.01, respectively. An overall 406 (58.4%) were female, and 394 (57.3%) had Kellgren-Lawrence grade 3 target knee OA. The PBO and sham groups demonstrated clinically meaningful improvements (≥10%) from baseline in all patient-reported outcomes at all time points (ie, weeks 4-24). Mean differences (95% CI) at week 24 between the PBO and sham groups were as follows: pain Numeric Rating Scale, -0.10 (-0.79 to 0.59; P = .78); WOMAC pain, -2.89 (-9.70 to 3.92; P = .40); WOMAC stiffness, -2.37 (-9.37 to 4.63; P = .51); and WOMAC function, -1.39 (-8.06 to 5.29; P = .68). Bang Blinding Index indicated that blinding was maintained.
CONCLUSIONS: PBO and sham groups demonstrated equivalent patient-reported outcomes at all time points through week 24, suggesting that responses attributed to saline were contextual (ie, to the procedure) and not physiological.
BACKGROUND: NCT03122860 (ClinicalTrials.gov identifier).
摘要：
背景：耐用，在膝骨关节炎（OA）试验中观察到关节内盐水安慰剂注射有意义的症状反应，但目前还不清楚这些是否是由于生理效应。
目的：对接受以盐水为基础的安慰剂或假手术（干针）关节内注射的膝关节OA患者报告的结果反应进行前瞻性比较。
方法：随机对照试验；证据水平，2.
方法：根据一项为期24周的随机双盲试验，中度至重度膝关节OA的参与者接受2-mL生理盐水安慰剂(PBO;99.45%PBS)或假注射(干针)至目标膝关节.在以下情况下，PBO和假手术组之间比较了从基线到第24周变化的最小二乘均值差异：疼痛数字评定量表；西安大略省和麦克马斯特大学骨关节炎指数（WOMAC）疼痛，刚度,和功能；以及患者全球评估。在第1天和第24周使用Bang致盲指数评估所有组致盲。
结果：总计，116和117名参与者被随机分为PBO和假手术组，分别。在全部试验人群中，平均±SD年龄和体重指数分别为59.0±8.5岁和28.97±4.01。共有406名（58.4%）为女性，394例(57.3%)患有Kellgren-Lawrence3级目标膝关节OA。在所有时间点的所有患者报告的结果中，PBO和假手术组显示出与基线相比有临床意义的改善（≥10％）（即，第4-24周）。在第24周，PBO和假手术组之间的平均差异（95％CI）如下：疼痛数字评定量表，-0.10（-0.79至0.59；P=0.78）；WOMAC疼痛，-2.89（-9.70至3.92；P=.40）；WOMAC刚度，-2.37（-9.37至4.63；P=.51）；和WOMAC功能，-1.39（-8.06至5.29；P=.68）。Bang致盲指数表明保持致盲。
结论：PBO和假手术组在第24周的所有时间点都显示出相等的患者报告结果，这表明归因于盐水的反应是有背景的（即，程序)而不是生理的。
背景：NCT03122860（ClinicalTrials.gov标识符）。
目的：对接受以盐水为基础的安慰剂或假手术（干针）关节内注射的膝关节OA患者报告的结果反应进行前瞻性比较。
方法：随机对照试验；证据水平，2.
方法：根据一项为期24周的随机双盲试验，中度至重度膝关节OA的参与者接受2-mL生理盐水安慰剂(PBO;99.45%PBS)或假注射(干针)至目标膝关节.在以下情况下，PBO和假手术组之间比较了从基线到第24周变化的最小二乘均值差异：疼痛数字评定量表；西安大略省和麦克马斯特大学骨关节炎指数（WOMAC）疼痛，刚度,和功能；以及患者全球评估。在第1天和第24周使用Bang致盲指数评估所有组致盲。
结果：总计，116和117名参与者被随机分为PBO和假手术组，分别。在全部试验人群中，平均±SD年龄和体重指数分别为59.0±8.5岁和28.97±4.01。共有406名（58.4%）为女性，394例(57.3%)患有Kellgren-Lawrence3级目标膝关节OA。在所有时间点的所有患者报告的结果中，PBO和假手术组显示出与基线相比有临床意义的改善（≥10％）（即，第4-24周）。在第24周，PBO和假手术组之间的平均差异（95％CI）如下：疼痛数字评定量表，-0.10（-0.79至0.59；P=0.78）；WOMAC疼痛，-2.89（-9.70至3.92；P=.40）；WOMAC刚度，-2.37（-9.37至4.63；P=.51）；和WOMAC功能，-1.39（-8.06至5.29；P=.68）。Bang致盲指数表明保持致盲。
结论：PBO和假手术组在第24周的所有时间点都显示出相等的患者报告结果，这表明归因于盐水的反应是有背景的（即，程序)而不是生理的。
背景：NCT03122860（ClinicalTrials.gov标识符）。
