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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
Idowu OA, Adeniyi AF, Edo A, Fasanmade A
Archives of Physiotherapy 2021 Apr 15;11(10):Epub
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 to 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 to 3.0; r = -0.1) and FAB (0.01 to -2.0; r = -0.1) at week 4, LBP-related disability (0.01 to -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).

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