Impact of a lumbar knee recovery device on sleep quality and blood glucose levels in diabetic patients with knee osteoarthritis: a randomized controlled trial
摘要
Sleep disturbances and poor glycemic control are common challenges in patients with type 2 diabetes and knee osteoarthritis. This study aimed to evaluate the effect of a back and knee recovery device on sleep quality and fasting blood glucose levels in this population.
MethodsIn this randomized controlled trial, 70 patients with type 2 diabetes and knee osteoarthritis were randomly assigned to intervention and control groups (n = 35 each). The back and knee recovery device was used by the intervention group for one hour daily over 10 consecutive days. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), and random blood glucose was measured daily using a unique glucometer machine. Statistical analyses included t-tests, Chi-square, and Generalized Estimating Equations (GEE), with a significance level set at p < 0.05.
ResultsAfter the intervention, the mean PSQI score significantly improved in the intervention group (from 11.65 ± 2.72 to 5.88 ± 1.87; p < 0.001), with 42.9% achieving good sleep quality, while no significant change was observed in the control group. Post-intervention analyses revealed significant improvements in six out of seven PSQI components in the intervention group. Additionally, blood glucose levels declined consistently across all 10 days (p < 0.001), and GEE modeling confirmed a significant time × group interaction effect.
ConclusionUse of the back and knee recovery device significantly improved sleep quality and glycemic control in patients with type 2 diabetes and knee osteoarthritis. This non-pharmacological approach may be beneficial as a complementary treatment in these patients.
Trial registration number: Iranian Registry of Clinical Trials (IRCT20191027045257N7).