2型糖尿病伴下背痛患者进行分级活动及每日监测步行与不进行每日监测步行的比较：一项随机临床试验的二次分析
Graded activity with and without daily-monitored-walking in patients with type 2 diabetes with low back pain: secondary analysis of a randomized-clinical trial.
作者信息
Idowu Opeyemi Ayodiipo, Adeniyi Ade Fatai, Edo Andrew, Fasanmade Adesoji
机构信息
Department of Physiotherapy, College of Medical Sciences, School of Basic Medical Sciences, University of Benin, Benin City, Nigeria.
Department of Physiotherapy, College of Medicine, University of Ibadan, Ibadan, Nigeria.
出版信息
Arch Physiother. 2021 Apr 15;11(1):10. doi: 10.1186/s40945-021-00104-3.
BACKGROUND
Graded activity is gradually emerging as a preferred choice in improving psychosocial outcomes including pain self-efficacy, fear-avoidance beliefs, and back-pain beliefs in the general population with low back pain (LBP). Such evidence is, however, lacking among patients with concomitant LBP and type-2 diabetes mellitus (T2DM). This secondary analysis of a randomized control trial aimed to compare the efficacy between graded activity augmented with additional daily-monitored-walking and graded activity alone on disability, pain self-efficacy (PSE), fear-avoidance beliefs (FAB), back-pain beliefs (BPB) and glycaemic control (HbA1c) in patients with concomitant LBP and T2DM.
METHODS
Fifty-eight patients with concomitant LBP and T2DM were randomised into two groups, graded activity with daily-monitored-walking group (GAMWG = 29) or (graded activity group (GAG = 29) in this 12-week single-blind trial. Both groups received graded activity (home/work-place visits, back school and sub-maximal exercises) while the GAMWG received additional daily-monitored-walking. Disability and selected psychosocial outcomes were assessed at weeks 0, 4, 8 and 12 using Roland-Morris disability, fear-avoidance behaviour, pain self-efficacy and back belief questionnaires. Glycaemic control was assessed at weeks 0 and 12 using a point-of-care system (In2it, Biorad Latvia). Data were analysed using mean, median, Friedman's ANOVA, Mann-Whitney test and t-tests.
RESULTS
Participants' mean age was 48.3 ± 9.4 years (95%CI: 45.6, 50.9) while 35.3% were males. The GAMWG participants (n = 25) had better outcomes (P < 0.05) than GAG participants (n = 26) on PSE (1.0, 3.0; r = - 0.1) and FAB (0.01, - 2.0; r = - 0.1) at week 4, LBP-related disability (0.01, - 2.0; r = - 0.2) at week 8 and glycaemic control at week 12 (- 0.59 ± 0.51%,-0.46 ± 0.22%). No other between-group comparisons were statistically significant.
CONCLUSION
Graded activity with daily-monitored-walking provided earlier improvements on disability, pain self-efficacy, fear-avoidance beliefs, and glycaemic control, but not back pain beliefs, in patients with concomitant LBP and T2DM.
TRIAL REGISTRATION
PACTR201702001728564 ; 26 July, 2016 (retrospectively registered).
背景
分级活动正逐渐成为改善心理社会结局的首选方法，这些结局包括一般人群中腰痛（LBP）患者的疼痛自我效能感、恐惧回避信念和背痛信念。然而，在伴有LBP和2型糖尿病（T2DM）的患者中缺乏此类证据。这项随机对照试验的二次分析旨在比较在伴有LBP和T2DM的患者中，额外增加每日监测步行的分级活动与单纯分级活动在残疾、疼痛自我效能感（PSE）、恐惧回避信念（FAB）、背痛信念（BPB）和血糖控制（糖化血红蛋白）方面的疗效。
方法
在这项为期12周的单盲试验中，58例伴有LBP和T2DM的患者被随机分为两组，即每日监测步行的分级活动组（GAMWG，n = 29）和分级活动组（GAG，n = 29）。两组均接受分级活动（家庭/工作场所访视、返校和次最大运动），而GAMWG组额外进行每日监测步行。在第0、4、8和12周，使用罗兰·莫里斯残疾问卷、恐惧回避行为问卷、疼痛自我效能感问卷和背痛信念问卷评估残疾情况和选定的心理社会结局。在第0和12周，使用即时检测系统（In2it，Biorad Latvia）评估血糖控制情况。使用均值、中位数、弗里德曼方差分析、曼-惠特尼检验和t检验对数据进行分析。
结果
参与者的平均年龄为48.3±9.4岁（95%置信区间：45.6，50.9），男性占35.3%。在第4周时，GAMWG组（n = 25）在PSE（1.0，3.0；r = -0.1）和FAB（0.01，-2.0；r = -0.1）方面的结局优于GAG组（n = 26）（P < 0.05）；在第8周时，GAMWG组在与LBP相关的残疾方面（0.01，-2.0；r = -0.2）优于GAG组；在第12周时，GAMWG组在血糖控制方面（-0.59±0.51%，-0.46±0.22%）优于GAG组。其他组间比较均无统计学意义。
结论
对于伴有LBP和T2DM的患者，额外增加每日监测步行的分级活动能在残疾、疼痛自我效能感、恐惧回避信念和血糖控制方面带来更早的改善，但在背痛信念方面没有改善。
试验注册
PACTR）201702001728564；2016年7月26日（追溯注册）。
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