Department of Public Health, Centre for Rehabilitation Research, Aarhus University, Aarhus C, Denmark.
Sano, Højbjerg, Denmark.
Clin Rehabil. 2021 Feb;35(2):232-241. doi: 10.1177/0269215520963856. Epub 2020 Oct 11.
To compare the long-term effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme, in terms of back-specific disability, in patients with chronic low back pain.
A single-centre, pragmatic, two-arm parallel, randomised controlled trial.
A rheumatology rehabilitation centre in Denmark.
A total of 165 adults (aged ⩾ 18 years) with chronic low back pain.
An integrated programme (a pre-admission day, two weeks at home, two weeks inpatient followed by home-based activities, plus two 2-day inpatient booster sessions, and six-month follow-up visit) was compared with an existing programme (four-week inpatient, and six-month follow-up visit).
The primary outcome was disability measured using the Oswestry Disability Index after one year. Secondary outcomes included pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory). Analysis was by intention-to-treat, using linear mixed models.
303 patients were assessed for eligibility of whom 165 patients (mean age 50 years (SD 13) with a mean Oswestry Disability Index score of 42 (SD 11)) were randomly allocated (1:1 ratio) to the integrated programme ( = 82) or the existing programme ( = 83). The mean difference (integrated programme minus existing programme) in disability was -0.53 (95% CI -4.08 to 3.02); = 0.770). No statistically significant differences were found in the secondary outcomes.
The integrated programme was not more effective in reducing long-term disability in patients with chronic low back pain than the existing programme.
比较综合康复方案与现有康复方案在慢性下腰痛患者的背部特异性残疾方面的长期疗效。
单中心、实用、双臂平行、随机对照试验。
丹麦风湿病康复中心。
共 165 名年龄 ⩾ 18 岁的慢性下腰痛成年人。
综合方案(预住院日、两周家庭治疗、两周住院治疗后家庭活动、两次 2 天住院强化治疗、六个月随访)与现有方案(四周住院治疗、六个月随访)进行比较。
一年后采用 Oswestry 残疾指数评估的残疾为主要结局。次要结局包括疼痛强度(数字评分量表)、疼痛自我效能(疼痛自我效能问卷)、健康相关生活质量(EuroQol-5 维度 5 级量表(EQ-5D))和抑郁(抑郁量表)。分析采用意向治疗,采用线性混合模型。
303 名患者进行了入选评估,其中 165 名患者(平均年龄 50 岁(SD 13),平均 Oswestry 残疾指数为 42(SD 11))被随机分配(1:1 比例)至综合方案(n=82)或现有方案(n=83)。残疾的综合方案与现有方案的平均差值为 -0.53(95%CI -4.08 至 3.02); = 0.770)。次要结局未见统计学差异。
与现有方案相比,综合康复方案在降低慢性下腰痛患者的长期残疾方面并无优势。