Department of Orthopedics, Kristianstad Hospital, Kristianstad, Sweden.
Department of Clinical Sciences-Orthopedics, Lund University, Lund, Sweden.
JAMA Netw Open. 2021 Oct 1;4(10):e2130753. doi: 10.1001/jamanetworkopen.2021.30753.
Local steroid injection is commonly used in treating patients with idiopathic carpal tunnel syndrome, but evidence regarding long-term efficacy is lacking.
To assess the long-term treatment effects of local steroid injection for carpal tunnel syndrome.
DESIGN, SETTING, AND PARTICIPANTS: This exploratory 5-year extended follow-up of a double-blind, placebo-controlled randomized clinical trial was conducted from November 2008 to March 2012 at a university hospital orthopedic department. Participants included patients aged 22 to 69 years with primary idiopathic carpal tunnel syndrome and no prior treatment with local steroid injections. Data were analyzed from May 2018 to August 2018.
Patients were randomized to injection of 80 mg methylprednisolone, 40 mg methylprednisolone, or saline.
The coprimary outcomes were the symptom severity score and rate of subsequent carpal tunnel release surgery on the study hand at 5 years. Secondary outcomes were time from injection to surgical treatment, SF-36 bodily pain score, and score on the 11-item disabilities of the arm, shoulder, and hand scale.
A total of 111 participants (mean [SD] age at follow-up, 52.9 [11.6] years; 81 [73.0%] women and 30 [27.0%] men) were randomized, with 37 in the 80 mg methylprednisolone group, 37 in the 40 mg methylprednisolone group, and 37 in the saline placebo group. Complete 5-year follow-up data were obtained from all 111 participants with no dropouts (100% follow-up). At baseline, mean (SD) symptom severity scores were 2.93 (0.85) in the 80 mg methylprednisolone group, 3.13 (0.70) in the 40 mg methylprednisolone group, and 3.18 (0.75) in the placebo group, and at the 5-year follow up, mean (SD) symptom severity scores were 1.51 (0.66) in the 80 mg methylprednisolone group, 1.59 (0.63) in the 40 mg methylprednisolone group, and 1.67 (0.74) in the placebo group. Compared with placebo, there was no significant difference in mean change in symptom severity score from baseline to 5 years for the 80 mg methylprednisolone group (0.14 [95%CI, -0.17 to 0.45]) or the 40 mg methylprednisolone group (0.12 [95%CI, -0.19 to 0.43]). After injection, subsequent surgical treatment on the study hand was performed in 31 participants (83.8%) in the 80 mg methylprednisolone group, 34 participants (91.9%) in the 40 mg methylprednisolone group, and 36 participants (97.3%) in the placebo group; the number of participants who underwent surgical treatment between the 1-year and 5-year follow-ups was 4 participants (10.8%) in the 80 mg methylprednisolone group, 4 participants (10.8%) in the 40 mg methylprednisolone group, and 2 participants (5.4%) in the placebo group. All surgical procedures were conducted while participants and investigators were blinded to type of injection received. The mean (SD) time from injection to surgery was 180 (121) days in the 80 mg methylprednisolone group, 185 (125) days in the 40 mg methylprednisolone group, and 121 (88) days in the placebo group. Kaplan-Meier survival curves showed statistically significant difference in time to surgical treatment (log-rank test: 80 mg methylprednisolone vs placebo, P = .002 ; 40 mg methylprednisolone vs placebo, P = .02; methylprednisolone 80 mg vs 40 mg, P = .37).
These findings suggest that in idiopathic carpal tunnel syndrome, local methylprednisolone injection resulted in statistically significant reduction in surgery rates and delay in need for surgery.
ClinicalTrials.gov Identifiers: NCT00806871 and NCT02652390.
重要性：局部类固醇注射常用于治疗特发性腕管综合征患者，但缺乏长期疗效的证据。
目的：评估局部类固醇注射治疗腕管综合征的长期疗效。
设计、地点和参与者：这是一项在大学医院骨科进行的为期 5 年的双盲、安慰剂对照随机临床试验的探索性随访，于 2008 年 11 月至 2012 年 3 月进行。参与者为年龄在 22 至 69 岁之间、原发性特发性腕管综合征且无局部类固醇注射史的患者。数据于 2018 年 5 月至 8 月进行分析。
干预措施：患者随机分为 80mg 甲基强的松龙、40mg 甲基强的松龙或生理盐水注射组。
主要结果和措施：主要结局是研究手的症状严重程度评分和随后腕管松解手术的比率，随访时间为 5 年。次要结局是从注射到手术治疗的时间、SF-36 身体疼痛评分和 11 项手臂、肩部和手部残疾量表评分。
结果：共有 111 名参与者（随访时的平均[标准差]年龄，52.9[11.6]岁；81[73.0%]名女性和 30[27.0%]名男性）被随机分为 80mg 甲基强的松龙组 37 名、40mg 甲基强的松龙组 37 名和生理盐水安慰剂组 37 名。所有 111 名参与者均完成了完整的 5 年随访，无失访（100%随访）。基线时，80mg 甲基强的松龙组的平均（标准差）症状严重程度评分为 2.93（0.85），40mg 甲基强的松龙组为 3.13（0.70），安慰剂组为 3.18（0.75），5 年随访时，80mg 甲基强的松龙组的平均（标准差）症状严重程度评分为 1.51（0.66），40mg 甲基强的松龙组为 1.59（0.63），安慰剂组为 1.67（0.74）。与安慰剂相比，80mg 甲基强的松龙组（0.14[95%CI，-0.17 至 0.45]）或 40mg 甲基强的松龙组（0.12[95%CI，-0.19 至 0.43]）从基线到 5 年的症状严重程度评分变化的平均差异无统计学意义。注射后，80mg 甲基强的松龙组 31 名（83.8%）、40mg 甲基强的松龙组 34 名（91.9%）和安慰剂组 36 名（97.3%）的研究手随后进行了手术治疗；80mg 甲基强的松龙组和 40mg 甲基强的松龙组分别有 4 名（10.8%）和 4 名（10.8%）参与者在 1 年和 5 年随访之间接受了手术治疗，安慰剂组有 2 名（5.4%）参与者接受了手术治疗。所有手术均在参与者和研究人员对接受的注射类型不知情的情况下进行。80mg 甲基强的松龙组的平均（标准差）从注射到手术的时间为 180（121）天，40mg 甲基强的松龙组为 185（125）天，安慰剂组为 121（88）天。Kaplan-Meier 生存曲线显示手术治疗时间存在统计学显著差异（对数秩检验：80mg 甲基强的松龙与安慰剂相比，P=0.002；40mg 甲基强的松龙与安慰剂相比，P=0.02；甲基强的松龙 80mg 与 40mg 相比，P=0.37）。
结论和相关性：这些发现表明，在特发性腕管综合征中，局部甲基强的松龙注射可显著降低手术率并延迟手术需求。
试验注册：ClinicalTrials.gov 标识符：NCT00806871 和 NCT02652390。
Zotero 插件