Abstract：
BACKGROUND: Complex regional pain syndrome (CRPS) can profoundly affect many aspects of everyday life. Spinal cord stimulation (SCS) is a potential therapeutic option. This retrospective, single-site evaluation explored health-related quality of life (HRQoL) in individuals with CRPS treated with SCS in our Pain Service.
METHODS: All patients aged ≥18 years with fully implanted SCS for CRPS between June 2013 and January 2023 were identified from hospital records. The following data were collected: sex, age, chronic pain diagnosis, CRPS type (I or II), location of CRPS (upper or lower limb), years of CRPS before first SCS implant, SCS system, preimplant and follow-up scores for HRQoL (euroqol 5 dimensions 3 levels [EQ-5D-3L] index score), average pain, worst pain and the influence of pain on aspects of everyday life (all numerical rating scale [NRS]), patient and clinician global impression of change at follow-up, and the occurrence and reasons for revisions and explants. An intention-to-treat approach was used and data statistically analyzed.
RESULTS: The final cohort comprised 83 patients (46 women), with a median (minimum, maximum) follow-up duration of 29 months (seven, 72). There were statistically and clinically significant improvements in HRQoL, despite relatively low pain response rates. The pain response rate was 34% (reduction of ≥30% in average pain NRS); the pain remission rate was 13% (average pain score ≤3 NRS), and all patients had preimplant EQ-5D-3L index values below the population norm of 0.82. However, 60% of patients reported EQ-5D-3L index scores greater than the published minimally important difference of 0.074, and scores were better at follow-up than at preimplant (p < 0.001); 44% of patients and 41% of clinicians reported improved symptoms at the most recent follow-up. Explants occurred in eight of 83 patients (10%).
CONCLUSIONS: Patients had meaningful improvements in HRQoL, which is a key outcome in ascertaining the overall outcome of SCS in CRPS. Randomized controlled clinical trials should build on the findings to improve understanding of the benefits and risks of treating CRPS with SCS.
METHODS: All patients aged ≥18 years with fully implanted SCS for CRPS between June 2013 and January 2023 were identified from hospital records. The following data were collected: sex, age, chronic pain diagnosis, CRPS type (I or II), location of CRPS (upper or lower limb), years of CRPS before first SCS implant, SCS system, preimplant and follow-up scores for HRQoL (euroqol 5 dimensions 3 levels [EQ-5D-3L] index score), average pain, worst pain and the influence of pain on aspects of everyday life (all numerical rating scale [NRS]), patient and clinician global impression of change at follow-up, and the occurrence and reasons for revisions and explants. An intention-to-treat approach was used and data statistically analyzed.
RESULTS: The final cohort comprised 83 patients (46 women), with a median (minimum, maximum) follow-up duration of 29 months (seven, 72). There were statistically and clinically significant improvements in HRQoL, despite relatively low pain response rates. The pain response rate was 34% (reduction of ≥30% in average pain NRS); the pain remission rate was 13% (average pain score ≤3 NRS), and all patients had preimplant EQ-5D-3L index values below the population norm of 0.82. However, 60% of patients reported EQ-5D-3L index scores greater than the published minimally important difference of 0.074, and scores were better at follow-up than at preimplant (p < 0.001); 44% of patients and 41% of clinicians reported improved symptoms at the most recent follow-up. Explants occurred in eight of 83 patients (10%).
CONCLUSIONS: Patients had meaningful improvements in HRQoL, which is a key outcome in ascertaining the overall outcome of SCS in CRPS. Randomized controlled clinical trials should build on the findings to improve understanding of the benefits and risks of treating CRPS with SCS.
摘要：
背景：复杂区域疼痛综合征（CRPS）可以深刻地影响日常生活的许多方面。脊髓刺激（SCS）是一种潜在的治疗选择。这次回顾，单中心评估探讨了在我们的疼痛服务机构中接受SCS治疗的CRPS患者的健康相关生活质量(HRQoL)。
方法：从医院记录中确定2013年6月至2023年1月期间所有年龄≥18岁的CRPS完全植入SCS的患者。收集了以下数据：性别，年龄,慢性疼痛诊断，CRPS类型（I或II），CRPS（上肢或下肢）的位置，在第一次植入SCS之前有几年的CRPS，SCS系统,HRQoL的植入前和随访评分（euroqol5维度3水平[EQ-5D-3L]指数评分），平均疼痛,最严重的疼痛和疼痛对日常生活各方面的影响（所有数字评定量表[NRS]），患者和临床医生对随访变化的整体印象，以及修订和外植体的发生和原因。使用了意向治疗方法，并对数据进行了统计分析。
结果：最终队列包括83名患者（46名女性），带中位数(最小值，最长)随访时间为29个月(7个月，72).HRQoL有统计学和临床意义的改善，尽管疼痛反应率相对较低。疼痛反应率为34%（平均疼痛NRS降低≥30%）；疼痛缓解率为13%（平均疼痛评分≤3NRS），所有患者的植入前EQ-5D-3L指数值均低于人口常模0.82。然而,60％的患者报告EQ-5D-3L指数得分高于发表的最低重要差异0.074，并且在随访时得分优于植入前（p<0.001）；44％的患者和41％的临床医生在最近的随访中报告症状改善。83例患者中有8例(10%)发生外植体。
结论：患者的HRQoL有有意义的改善，这是确定CRPS中SCS总体结果的关键结果。随机对照临床试验应以这些发现为基础，以提高对用SCS治疗CRPS的益处和风险的认识。
方法：从医院记录中确定2013年6月至2023年1月期间所有年龄≥18岁的CRPS完全植入SCS的患者。收集了以下数据：性别，年龄,慢性疼痛诊断，CRPS类型（I或II），CRPS（上肢或下肢）的位置，在第一次植入SCS之前有几年的CRPS，SCS系统,HRQoL的植入前和随访评分（euroqol5维度3水平[EQ-5D-3L]指数评分），平均疼痛,最严重的疼痛和疼痛对日常生活各方面的影响（所有数字评定量表[NRS]），患者和临床医生对随访变化的整体印象，以及修订和外植体的发生和原因。使用了意向治疗方法，并对数据进行了统计分析。
结果：最终队列包括83名患者（46名女性），带中位数(最小值，最长)随访时间为29个月(7个月，72).HRQoL有统计学和临床意义的改善，尽管疼痛反应率相对较低。疼痛反应率为34%（平均疼痛NRS降低≥30%）；疼痛缓解率为13%（平均疼痛评分≤3NRS），所有患者的植入前EQ-5D-3L指数值均低于人口常模0.82。然而,60％的患者报告EQ-5D-3L指数得分高于发表的最低重要差异0.074，并且在随访时得分优于植入前（p<0.001）；44％的患者和41％的临床医生在最近的随访中报告症状改善。83例患者中有8例(10%)发生外植体。
结论：患者的HRQoL有有意义的改善，这是确定CRPS中SCS总体结果的关键结果。随机对照临床试验应以这些发现为基础，以提高对用SCS治疗CRPS的益处和风险的认识。
