Sleep Management Combined with Rehabilitation Exercise to Alleviate Chronic Pain Following Total Knee Arthroplasty: A Randomized Controlled Trial.

Abstract

Chronic pain following total knee arthroplasty (TKA) remains a frequent and debilitating complication that impairs recovery and quality of life. Sleep disturbances often co-occur with chronic pain, forming a bidirectional cycle that complicates postoperative rehabilitation. Current pharmacological treatments provide limited relief for persistent pain, especially when complicated by sleep or mood disorders. This study investigated whether combining cognitive behavioral therapy for insomnia (CBT-I) with structured rehabilitation exercise could offer a non-pharmacologic solution. A single-center, randomized controlled trial was conducted with 80 patients experiencing persistent pain ≥ three months after TKA. Participants were randomized into two groups (n = 40 each): an intervention group receiving CBT-I plus tailored physical rehabilitation, and a control group receiving conventional analgesics. Assessments were performed at baseline and at weeks one, two, four, and 12 post-intervention. Primary outcomes included Visual Analog Scale (VAS), Hospital for Special Surgery (HSS) score, range of motion (ROM), and knee joint swelling (measured by limb circumference). The secondary outcomes included the Pittsburgh Sleep Quality Index (PSQI) and the Hospital Anxiety and Depression Scale (HADS). Safety indicators were monitored. All follow-up assessments (week one, two, four, and 12) were calculated from the start of the intervention (baseline, T0). All participants were enrolled three to seven months after TKA (means ± SD: 4.8 ± 1.2 months); therefore, the reported weeks represent 'post-intervention' rather than 'post-surgery' time points. Compared to baseline, the intervention group demonstrated significantly greater improvements in VAS, HSS, ROM, and swelling from week two onward (P < 0.05). Sleep quality (PSQI) and psychological health (HADS) were also significantly improved at multiple time points compared to the control group (P < 0.05). There were no serious adverse events reported, and treatment adherence was high. A multimodal intervention combining CBT-I and rehabilitation exercises offers an effective, safe, and patient-centered strategy to manage chronic pain after TKA. This approach not only relieves pain and inflammation but also enhances sleep quality and psychological well-being. It should be considered as a complementary strategy in routine postoperative rehabilitation programs for patients at high-risk.