Data for: Supervised physical therapy versus home exercise for patients with lumbar spinal stenosis: a randomized controlled trial

This data is a single-center, open-label, randomized controlled trial comparing supervised physical therapy (PT) with home exercise (HE) for patients with lumbar spinal stenosis. The purposes of this study were to identify which types of exercise are effective and quantify physical activity using a pedometer to confirm compliance with the home exercise program. At baseline, there were no significant differences in age, sex, body mass index, duration of symptoms, MRI findings, and the outcome measures between groups (P > 0.05). At 6 weeks, compared with the HE group, the PT group showed significant improvements in ZCQ symptom severity (mean difference –0.4; 95% confidence interval [CI]: –0.6 to –0.2, P = 0.001), ZCQ physical function (mean difference –0.4; 95% CI: –0.6 to –0.2, P < 0.001), walking distance on the SPWT (mean difference 455.9 m; 95% CI: 308.5 to 603.2, P < 0.001), leg pain (mean difference –1.4; 95% CI: –2.5 to –0.3, P = 0.013) on the NRS, gait disturbance (mean difference 16.0; 95% CI: 5.4 to 26.7, P = 0.004) on the JOABPEQ, physical functioning (mean difference 9.2; 95% CI: 2.1 to 16.3, P = 0.012) and bodily pain (mean difference 10.4; 95% CI: 3.3 to 17.5, P = 0.005) on the SF-36, the TSK-11 (mean difference –2.1; 95% CI: –3.9 to –0.2, P = 0.027), and number of daily steps (mean difference 723.4 steps/day; 95% CI: 199.1 to 1283.5, P = 0.008). Twenty-seven of 43 patients (62.8%) in the PT group reached a threshold of MCID of 0.36 for ZCQ symptom severity scale compared with 14 of 43 patients (32.6%) in the HE group (P = 0.009). The Fragility Index value was 3 which indicates that if 3 patients in PT group did not reach a threshold of MCID, the difference between groups lose statistical significance (P > 0.05). The self-reported home exercise compliance did not differ significantly between the two groups during the 6-week treatment period (PT group 39.1/42 days, HE group 39.1/42 days, P = 0.985). We found that supervised physical therapy resulted in significant short-term improvements in symptom severity, physical function, walking distance, pain, and physical activity compared with unsupervised exercise.

本数据集来源于一项单中心、开放标签随机对照试验，旨在对比监督下物理治疗（Physical Therapy, PT）与家庭锻炼（Home Exercise, HE）对腰椎管狭窄症患者的干预效果。本研究的目的在于明确何种运动方式更为有效，并通过计步器量化身体活动水平，以验证家庭锻炼方案的依从性。基线时，两组患者在年龄、性别、体质量指数、症状持续时间、MRI表现及结局指标上均无显著差异（P>0.05）。干预6周后，与HE组相比，PT组患者在以下指标上均获得显著改善：ZCQ症状严重程度量表（ZCQ）评分（均数差：-0.4；95%置信区间〔CI〕：-0.6~-0.2，P=0.001）、ZCQ身体功能评分（均数差：-0.4；95%CI：-0.6~-0.2，P<0.001）、SPWT步行距离（均数差：455.9m；95%CI：308.5~603.2，P<0.001）、数字疼痛评分量表（Numerical Rating Scale, NRS）评估的下肢疼痛评分（均数差：-1.4；95%CI：-2.5~-0.3，P=0.013）、日本骨科协会腰痛评估问卷（Japanese Orthopaedic Association Back Pain Evaluation Questionnaire, JOABPEQ）评估的步态障碍评分（均数差：16.0；95%CI：5.4~26.7，P=0.004）、简明健康调查量表（Short Form 36, SF-36）评估的身体功能评分（均数差：9.2；95%CI：2.1~16.3，P=0.012）与躯体疼痛评分（均数差：10.4；95%CI：3.3~17.5，P=0.005）、Tampa运动恐惧量表11项版（Tampa Scale for Kinesiophobia, TSK-11）评分（均数差：-2.1；95%CI：-3.9~-0.2，P=0.027），以及每日步行步数（均数差：723.4步/天；95%CI：199.1~1283.5，P=0.008）。PT组43例患者中有27例（62.8%）达到ZCQ症状严重程度量表的最小临床重要差异（Minimum Clinically Important Difference, MCID）阈值0.36，而HE组为14/43例（32.6%），组间差异具有统计学意义（P=0.009）。本研究的脆弱性指数（Fragility Index）为3，这意味着若PT组中有3例患者未达到MCID阈值，则两组间的差异将丧失统计学意义（P>0.05）。在6周治疗期间，两组患者自我报告的家庭锻炼依从性无显著差异（PT组：39.1/42天，HE组：39.1/42天，P=0.985）。本研究结果显示，与无监督锻炼相比，监督下物理治疗可使患者在症状严重程度、身体功能、步行距离、疼痛及身体活动方面获得显著的短期改善。