监督运动疗法与生物心理社会方法联合或不联合治疗慢性非特异性下腰痛的随机对照试验。

Comparison of supervised exercise therapy with or without biopsychosocial approach for chronic nonspecific low back pain: a randomized controlled trial.

机构信息

Faculty of Health Studies, University of Mostar, Mostar, Bosnia and Herzegovina.

Rehabilitation Center "Život", Mostar, Bosnia and Herzegovina.

出版信息

BMC Musculoskelet Disord. 2022 Nov 8;23(1):966. doi: 10.1186/s12891-022-05908-3.

DOI:10.1186/s12891-022-05908-3

PMID:36348309

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9641911/

Abstract

BACKGROUND

A biopsychosocial rehabilitation is recommended for chronic nonspecific low back pain (CNLBP); however, its effectiveness compared to the traditional supervised exercise therapy of CNLBP treatment is still unclear.

METHODS

This was a parallel-group randomized controlled clinical trial. The sample consisted of 180 participants of both sexes, aged ≥18 years, with CNLBP for ≥3 months. Using web randomization and concealed allocation, they were assigned to three groups; graded activity receiving cognitive-behavioral therapy, group-based combined exercise therapy and education (GA; n = 59), supervised group-based combined exercise therapy and education (SET; n = 63), and a control group receiving usual care (n = 58). Interventions were administered for 4 weeks (8 sessions). The primary outcome was pain intensity. Outcome measures were collected baseline, after interventions (4 weeks), and during two follow-up periods (3 and 6 months).

RESULTS

After the intervention, GA had a significant large effect on pain reduction compared to the control group (MD of 22.64 points; 95% CI = 16.10 to 29.19; p < 0.0001; Cohen's d = 1.70), as well as SET compared with the control group (MD of 21.08 points; 95% CI = 14.64 to 27.52; p < 0.0001; Cohen's d = 1.39), without significant difference between two intervention groups. At 3 and 6 months of follow-up, GA had a statistically significantly better effect in reducing pain, disability and fear-avoidance beliefs, and improving spinal extensor endurance, range of extension and quality of life compared to SET and the control group. A statistically significantly better effect of SET compared with the control group was found in reducing pain, disability, fear-avoidance beliefs, and improving the physical component of quality of life. Harms were not reported.

CONCLUSION

This study suggests that graded activity and group-based supervised exercise therapy have beneficial effects over the control group in the treatment of CNLBP. The graded activity was more beneficial than supervised group-based exercise therapy only during the follow-up.

TRIAL REGISTRATION

Clinicaltrials.gov (NCT04023162; registration date: 17/07/2019).

摘要

背景

慢性非特异性下腰痛（CNLBP）推荐采用生物心理社会康复治疗；然而，与传统的 CNLBP 治疗监督下的运动疗法相比，其疗效仍不清楚。

方法

这是一项平行组随机对照临床试验。样本包括 180 名年龄≥18 岁、CNLBP 持续时间≥3 个月的男女参与者。使用网络随机和隐藏分配，将他们分为三组；接受认知行为治疗的分级活动、基于小组的综合运动治疗和教育（GA；n=59）、监督小组的综合运动治疗和教育（SET；n=63）以及接受常规护理的对照组（n=58）。干预措施在 4 周（8 次）内进行。主要结局为疼痛强度。在基线、干预后（4 周）以及两个随访期（3 个月和 6 个月）时进行了测量。

结果

干预后，GA 与对照组相比，疼痛减轻的效果显著较大（MD 为 22.64 分；95%CI=16.10 至 29.19；p<0.0001；Cohen's d=1.70），SET 与对照组相比，疼痛减轻的效果也显著较大（MD 为 21.08 分；95%CI=14.64 至 27.52；p<0.0001；Cohen's d=1.39），但两组干预之间无显著差异。在 3 和 6 个月的随访中，GA 在降低疼痛、残疾和回避恐惧信念，以及改善脊柱伸肌耐力、伸展范围和生活质量方面的效果均显著优于 SET 和对照组，SET 与对照组相比，降低疼痛、残疾、回避恐惧信念，以及改善生活质量的身体成分方面的效果也显著更好。未报告危害。