Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.
Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.
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DOI：
10.1001/jamanetworkopen.2021.13401
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发表时间：
2021-08-02
影响因子：
13.8
通讯作者：
Mackey SC
中科院分区：
文献类型：
--
作者：
Darnall BD;Roy A;Chen AL;Ziadni MS;Keane RT;You DS;Slater K;Poupore-King H;Mackey I;Kao MC;Cook KF;Lorig K;Zhang D;Hong J;Tian L;Mackey SC
治疗后 3 个月时，单次止痛课程是否不劣于 8 次认知行为治疗 (CBT)？在这项纳入 263 名患有慢性腰痛的成年人的 3 组随机临床试验中，单次疼痛管理技能课程不劣于 8 周的 CBT，并且在治疗后 3 个月的疼痛灾难性和多个次要结局方面优于健康教育课程。对于慢性腰痛患者，单次疼痛缓解技能课程在治疗后 3 个月的疼痛灾难化、疼痛强度和疼痛干扰等结果方面显示出与 CBT 相当的疗效。这项随机临床试验对慢性腰痛患者的单次疼痛管理技能课程与 8 次认知行为治疗和 1 次健康教育进行了比较。慢性腰痛 (CLBP) 是最常见的慢性疼痛病症，会造成严重的残疾和不适。认知行为疗法 (CBT) 可以降低 CLBP 的效果，但其使用机会有限。旨在确定单一课程的循证疼痛管理技能（授权缓解）在改善疼痛灾难性、疼痛强度、疼痛干扰和其他次要结果方面是否不劣于 8 次 CBT，且优于治疗后 3 个月的健康教育。这项三组随机临床试验收集了 2017 年 5 月 24 日至 2020 年 3 月 3 日的数据。参与者包括社区中自我报告 CLBP 持续 6 个月或更长时间且平均疼痛强度至少为 4 的个体（范围为 0-10，其中 10 表示可想象的最严重疼痛）。使用意向治疗和符合方案的方法分析数据。参与者被随机分配到 (1) 授权救济、(2) 健康教育（与授权救济的持续时间和形式相匹配）或 (3) 8 次 CBT。在基线、治疗前以及治疗后第 1、2 和 3 个月收集自我报告的数据。治疗后第 3 个月的疼痛灾难化量表评分和次要结果存在组间差异。疼痛强度和疼痛干扰是优先的次要结果。共有 263 名参与者参与了分析（131 名女性 [49.8%]、130 名男性 [49.4%] 和另外 2 名 [0.8%]；平均 [SD] 年龄为 47.9 [13.8] 岁），并被随机分为 3 组：授权救济组 (n = 87)、CBT (n = 88) 和健康教育组 (n = 88)。 3 个月时的疼痛灾难性评分的授权缓解效果不逊色于 CBT（与 CBT 的差异， 1.39 [97.5% CI， −∞ 至 4.24]）。授权缓解和 CBT 在疼痛灾难性评分方面优于健康教育（授权缓解与健康教育的差异， −5.90 [95% CI， −8.78 至 -3.01；P < .001]；CBT 与健康教育的差异，−7.29 [95% CI， −10.20 至 -4.38；P < .001] P < .001]）。治疗后 3 个月，授权缓解和 CBT 的疼痛灾难性评分降低具有临床意义（授权缓解，-9.12 [95% CI，-11.6 至 -6.67；P < .001]；CBT，-10.94 [95% CI，-13.6 至 -8.32；P < .001]；健康教育，-4.60 [95% CI，-7.18 至 -2.01；P = .001]）。第 1 至 3 个月的疼痛灾难化的组间比较根据基线疼痛灾难化评分进行调整，并使用意向治疗分析。在疼痛强度和疼痛干扰（优先次要结果）、睡眠障碍、疼痛困扰、疼痛行为、抑郁和焦虑方面，授权缓解不逊色于 CBT。就身体功能而言，授权缓解不如 CBT。在患有 CLBP 的成人中，单次疼痛管理课程在疼痛灾难化、疼痛强度、疼痛干扰和其他次要结果方面产生了临床显着改善，这些改善在 3 个月时不劣于 8 次 CBT。 ClinicalTrials.gov 标识符：NCT03167086
Is a single-session pain relief class noninferior to 8 sessions of cognitive behavioral therapy (CBT) at 3 months after treatment? In this 3-arm randomized clinical trial that included 263 adults with chronic low back pain, a single-session pain management skills class was noninferior to 8 weeks of CBT and superior to a health education class for pain catastrophizing and multiple secondary outcomes at 3 months after treatment. For patients with chronic low back pain, a single-session pain relief skills class showed comparable efficacy to CBT in pain catastrophizing, pain intensity, and pain interference and other outcomes at 3 months after treatment. This randomized clinical trial compares a single-session pain management skills class with 8 sessions of cognitive behavioral therapy and 1 session of health education for patients with chronic low back pain. Chronic low back pain (CLBP), the most prevalent chronic pain condition, imparts substantial disability and discomfort. Cognitive behavioral therapy (CBT) reduces the effect of CLBP, but access is limited. To determine whether a single class in evidence-based pain management skills (empowered relief) is noninferior to 8-session CBT and superior to health education at 3 months after treatment for improving pain catastrophizing, pain intensity, pain interference, and other secondary outcomes. This 3-arm randomized clinical trial collected data from May 24, 2017, to March 3, 2020. Participants included individuals in the community with self-reported CLBP for 6 months or more and an average pain intensity of at least 4 (range, 0-10, with 10 indicating worst pain imaginable). Data were analyzed using intention-to-treat and per-protocol approaches. Participants were randomized to (1) empowered relief, (2) health education (matched to empowered relief for duration and format), or (3) 8-session CBT. Self-reported data were collected at baseline, before treatment, and at posttreatment months 1, 2, and 3. Group differences in Pain Catastrophizing Scale scores and secondary outcomes at month 3 after treatment. Pain intensity and pain interference were priority secondary outcomes. A total of 263 participants were included in the analysis (131 women [49.8%], 130 men [49.4%], and 2 other [0.8%]; mean [SD] age, 47.9 [13.8] years) and were randomized into 3 groups: empowered relief (n = 87), CBT (n = 88), and health education (n = 88). Empowered relief was noninferior to CBT for pain catastrophizing scores at 3 months (difference from CBT, 1.39 [97.5% CI, −∞ to 4.24]). Empowered relief and CBT were superior to health education for pain catastrophizing scores (empowered relief difference from health education, −5.90 [95% CI, −8.78 to −3.01; P < .001]; CBT difference from health education, −7.29 [95% CI, −10.20 to −4.38; P < .001]). Pain catastrophizing score reductions for empowered relief and CBT at 3 months after treatment were clinically meaningful (empowered relief, −9.12 [95% CI, −11.6 to −6.67; P < .001]; CBT, −10.94 [95% CI, −13.6 to −8.32; P < .001]; health education, −4.60 [95% CI, −7.18 to −2.01; P = .001]). Between-group comparisons for pain catastrophizing at months 1 to 3 were adjusted for baseline pain catastrophizing scores and used intention-to-treat analysis. Empowered relief was noninferior to CBT for pain intensity and pain interference (priority secondary outcomes), sleep disturbance, pain bothersomeness, pain behavior, depression, and anxiety. Empowered relief was inferior to CBT for physical function. Among adults with CLBP, a single-session pain management class resulted in clinically significant improvements in pain catastrophizing, pain intensity, pain interference, and other secondary outcomes that were noninferior to 8-session CBT at 3 months. ClinicalTrials.gov Identifier: NCT03167086
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影响因子：
4
作者：
Seminowicz, David A.;Shpaner, Marina;Keaser, Michael L.;Krauthamer, G. Michael;Mantegna, John;Dumas, Julie A.;Newhouse, Paul A.;Filippi, Christopher G.;Keefe, Francis J.;Naylor, Magdalena R.
通讯作者：
Naylor, Magdalena R.
影响因子：
3.1
作者：
Osman, A;Barrios, FX;Grittmann, L
通讯作者：
Grittmann, L
影响因子：
4.1
作者：
Burns, JW;Glenn, B;Lofland, K
通讯作者：
Lofland, K
影响因子：
5.3
作者：
Sheehan, DV;Lecrubier, Y;Dunbar, GC
通讯作者：
Dunbar, GC
影响因子：
3.6
作者：
Nicholas, Michael K.
通讯作者：
Nicholas, Michael K.