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Effect of Graded Sensorimotor Retraining on Pain Intensity in Patients With Chronic Low Back Pain: A Randomized Clinical Trial.
JAMA ( IF 120.7 ) Pub Date : 2022-08-02 , DOI: 10.1001/jama.2022.9930
Matthew K Bagg 1, 2, 3 , Benedict M Wand 4 , Aidan G Cashin 1, 5 , Hopin Lee 6, 7 , Markus Hübscher 1 , Tasha R Stanton 8 , Neil E O'Connell 9 , Edel T O'Hagan 1, 10 , Rodrigo R N Rizzo 1, 5 , Michael A Wewege 1, 5 , Martin Rabey 1 , Stephen Goodall 11 , Sopany Saing 11 , Serigne N Lo 12, 13 , Hannu Luomajoki 14 , Robert D Herbert 15 , Chris G Maher 16, 17 , G Lorimer Moseley 8 , James H McAuley 1, 5
Affiliation  

Importance The effects of altered neural processing, defined as altering neural networks responsible for perceptions of pain and function, on chronic pain remains unclear. Objective To estimate the effect of a graded sensorimotor retraining intervention (RESOLVE) on pain intensity in people with chronic low back pain. Design, Setting, and Participants This parallel, 2-group, randomized clinical trial recruited participants with chronic (>3 months) nonspecific low back pain from primary care and community settings. A total of 276 adults were randomized (in a 1:1 ratio) to the intervention or sham procedure and attention control groups delivered by clinicians at a medical research institute in Sydney, Australia. The first participant was randomized on December 10, 2015, and the last was randomized on July 25, 2019. Follow-up was completed on February 3, 2020. Interventions Participants randomized to the intervention group (n = 138) were asked to participate in 12 weekly clinical sessions and home training designed to educate them about and assist them with movement and physical activity while experiencing lower back pain. Participants randomized to the control group (n = 138) were asked to participate in 12 weekly clinical sessions and home training that required similar time as the intervention but did not focus on education, movement, and physical activity. The control group included sham laser and shortwave diathermy applied to the back and sham noninvasive brain stimulation. Main Outcomes and Measures The primary outcome was pain intensity at 18 weeks, measured on an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]) for which the between-group minimum clinically important difference is 1.0 point. Results Among 276 randomized patients (mean [SD] age, 46 [14.3] years; 138 [50%] women), 261 (95%) completed follow-up at 18 weeks. The mean pain intensity was 5.6 at baseline and 3.1 at 18 weeks in the intervention group and 5.8 at baseline and 4.0 at 18 weeks in the control group, with an estimated between-group mean difference at 18 weeks of -1.0 point ([95% CI, -1.5 to -0.4]; P = .001), favoring the intervention group. Conclusions and Relevance In this randomized clinical trial conducted at a single center among patients with chronic low back pain, graded sensorimotor retraining, compared with a sham procedure and attention control, significantly improved pain intensity at 18 weeks. The improvements in pain intensity were small, and further research is needed to understand the generalizability of the findings. Trial Registration ANZCTR Identifier: ACTRN12615000610538.

中文翻译:

分级感觉运动再训练对慢性腰痛患者疼痛强度的影响:一项随机临床试验。

重要性 神经处理改变(定义为改变负责感知疼痛和功能的神经网络)对慢性疼痛的影响仍不清楚。目的 评估分级感觉运动再训练干预 (RESOLVE) 对慢性腰痛患者疼痛强度的影响。设计、地点和参与者 这项平行的 2 组随机临床试验从初级保健机构和社区机构招募患有慢性(> 3 个月)非特异性腰痛的参与者。共有 276 名成年人被随机分配(以 1:1 的比例)到澳大利亚悉尼一家医学研究所的临床医生提供的干预或假手术和注意力控制组。第一位参与者于 2015 年 12 月 10 日随机分组,最后一位参与者于 2019 年 7 月 25 日随机分组。随访于 2020 年 2 月 3 日完成。干预 随机分配到干预组的参与者 (n = 138) 被要求参加每周 12 次的临床会议和家庭培训,旨在教育他们并帮助他们在体验期间进行运动和身体活动下背部疼痛。随机分配到对照组的参与者 (n = 138) 被要求参加每周 12 次的临床会议和家庭训练,这些训练需要与干预相似的时间,但不关注教育、运动和身体活动。对照组包括应用于背部的假激光和短波透热疗法以及假无创脑刺激。主要结果和测量 主要结果是 18 周时的疼痛强度,采用 11 分数值评定量表(范围,0 [无痛] 至 10 [可想象的最严重疼痛]),其中组间最小临床重要差异为 1.0 分。结果 在 276 名随机分组的患者(平均 [SD] 年龄,46 [14.3] 岁;138 名 [50%] 女性)中,261 名 (95%) 在 18 周时完成了随访。干预组的平均疼痛强度在基线时为 5.6,在 18 周时为 3.1,在对照组中在基线时为 5.8,在 18 周时为 4.0,估计 18 周时的组间平均差异为 -1.0 点([95% CI,-1.5 至 -0.4];P = .001),有利于干预组。结论和相关性 在这项在慢性腰痛患者中在单一中心进行的随机临床试验中,与假手术和注意力控制相比,分级感觉运动再训练在 18 周时显着改善了疼痛强度。疼痛强度的改善很小,需要进一步研究以了解研究结果的普遍性。试用注册 ANZCTR 标识符:ACTRN12615000610538。
更新日期:2022-08-02
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