Efficacy of cognitive functional therapy for pain intensity and disability in patients with non-specific chronic low back pain: a randomised sham-controlled trial

IF 11.6 1区医学 Q1 SPORT SCIENCES

British Journal of Sports Medicine Pub Date : 2025-03-06 DOI:10.1136/bjsports-2024-109012

Mariana Romano de Lira, Ney Meziat-Filho, Gabriela Zuelli Martins Silva, Julia Castro, Jessica Fernandez, Rinaldo Roberto de Jesus Guirro, Roger Berg, Thais Cristina Chaves

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Abstract

Objective This study investigated the efficacy of cognitive functional therapy (CFT) versus a sham procedure for pain intensity and disability for patients with non-specific chronic low back pain (CLBP). Methods This is a randomised sham-controlled trial conducted in a primary care public health service. A total of 152 participants were randomly assigned to the CFT group (n=76) and the sham group (n=76). The CFT group received six 1 hour individualised sessions; the sham procedure group received six individual sessions of neutral talking+detuned photobiomodulation (low-level laser therapy) equipment. Both groups received an education booklet with information on strategies for CLBP self-management. Primary outcomes were pain intensity and disability at 6 weeks. Participants were assessed preintervention, postintervention (at 6 weeks), and 3 and 6 months after randomisation. Results We obtained primary outcome data from 97.4% (n=74) of participants in the CFT group and 98.7% (n=75) from the sham group. The CFT group showed greater effects in pain intensity (mean difference (MD)=−1.8; 95% CI −2.5 to −1.1) and disability (MD=−9.9; 95% CI −13.2 to −6.5) postintervention compared with the sham group. The effect remained at the 3-month and 6-month follow-ups. Conclusions CFT showed sustained clinical efficacy compared with a sham procedure for treating pain intensity and disability in patients with CLBP. Trial registration number This trial was registered in ClinicalTrials.gov, [NCT04518891][1] and was previously published . Data are available upon reasonable request. The study protocol, participant consent and information forms, de-identified individual participant data, the data dictionary and statistical code can be made available by request to the corresponding author. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04518891&atom=%2Fbjsports%2Fearly%2F2025%2F03%2F05%2Fbjsports-2024-109012.atom

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认知功能疗法对非特异性慢性腰痛患者疼痛强度和残疾的疗效：一项随机假对照试验

目的研究认知功能疗法（CFT）与假手术对非特异性慢性腰痛（CLBP）患者疼痛强度和残疾的疗效。方法在初级保健公共卫生服务机构进行随机对照试验。共有152名参与者被随机分配到CFT组（n=76）和假手术组（n=76）。CFT组接受6次1小时的个体化治疗；假手术组接受6次单独的中性谈话+调谐光生物调节（低水平激光治疗）设备。两组都收到了一本关于CLBP自我管理策略信息的教育小册子。主要结局是疼痛强度和6周时的残疾。参与者在随机化后的干预前、干预后（6周）、3个月和6个月进行评估。我们从97.4% （n=74）的CFT组和98.7% （n=75）的假手术组获得了主要结局数据。CFT组对疼痛强度的影响更大(平均差(MD)=−1.8；95% CI为−2.5至−1.1)和残疾(MD=−9.9；与假手术组相比，干预后95% CI为−13.2 ~−6.5)。在3个月和6个月的随访中，效果仍然存在。结论：与假手术相比，CFT在治疗CLBP患者疼痛强度和残疾方面具有持续的临床疗效。该试验已在ClinicalTrials.gov注册，[NCT04518891][1]，此前已发表。如有合理要求，可提供资料。研究方案、参与者同意和信息表、去识别的个体参与者数据、数据字典和统计代码可应通信作者要求提供。[1]: /查找/ external-ref ? link_type = CLINTRIALGOV&access_num = NCT04518891&atom = % 2 fbjsports % 2恐惧% 2 f2025 % 2 f03 % 2 f05 % 2 fbjsports - 2024 - 109012. -原子

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来源期刊

British Journal of Sports Medicine 医学-运动科学

CiteScore

27.10

自引率

4.90%

发文量

217

审稿时长

3-8 weeks

期刊介绍： The British Journal of Sports Medicine (BJSM) is a dynamic platform that presents groundbreaking research, thought-provoking reviews, and meaningful discussions on sport and exercise medicine. Our focus encompasses various clinically-relevant aspects such as physiotherapy, physical therapy, and rehabilitation. With an aim to foster innovation, education, and knowledge translation, we strive to bridge the gap between research and practical implementation in the field. Our multi-media approach, including web, print, video, and audio resources, along with our active presence on social media, connects a global community of healthcare professionals dedicated to treating active individuals.