Promoting Sleep to Alleviate Pain - Arthroplasty — PROSAP-A  

Surgery Clinical Trial

Official title: Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

PROSAP-A is a perioperative randomized, controlled trial with a 12-month follow-up period after total knee arthroplasty (TKA) or total hip arthroplasty (THA), aiming to investigate both acute and long-term postoperative effects of preoperative sleep-promotion. Participants with clinically significant insomnia symptoms will be randomized to a brief, hybrid version of cognitive behavioral therapy for insomnia (CBT-I) or sleep education therapy, administered over a 4-week period, prior to surgery. The primary objectives are to evaluate effects of preoperative sleep-promotion on acute and long-term postoperative pain control. Secondary objectives include evaluation of postoperative sleep, recovery, mental health, cognitive function and alterations in blood biomarkers.

Clinical Trial Description

Although preoperative sleep disturbance is associated with poorer acute postoperative pain control, as well as development of chronic postsurgical pain, only very limited attempts have been made to target preoperative sleep to achieve improved postoperative outcomes. This study addresses two chronic pain populations, TKA and THA patients, that suffer severely due to both sleep disturbance and painful symptoms. Patients who meet eligibility criteria including sleep problems corresponding to insomnia severity index score ≥15, i.e., clinical insomnia, will be randomized to a brief, hybrid version of CBT-I or sleep education therapy over a 4-week period, before surgery. The CBT-I will focus on the two components which have shown the highest efficacy for sleep improvement, sleep restriction therapy and stimulus control. The CBT-I treatment will be administered in self-guided digital format with addition of telehealth video-consultations with a psychologist one time per week. The sleep education therapy will also be provided in a hybrid format, including digital sessions and video-consultations with a research nurse. There will also be a booster session 1-2 weeks postoperative for both interventions. Participants will be carefully evaluated during on-site visits two times preoperative, pre- and post-intervention, and one time 6 months postoperative. During on-site visits, participants will complete multiple questionnaires (covering pain, pain catastrophizing, mental health, physical function, activity etc), undergo digital cognitive testing, quantitative sensory testing (QST, to determine pain detection thresholds to different stimuli, assess temporal summation, pain inhibitory capacity), provide blood samples, and initiate actigraphy (objective assessment of sleep continuity measures). In addition to the on-site visits, participants will complete questionnaires remotely 3 and 12 months after surgery. ;

Related Conditions & MeSH terms

• Insomnia
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Pain, Postoperative
• Postoperative Complications
• Sleep Initiation and Maintenance Disorders
• Surgery

• NCT number: NCT06145516
• Study type: Interventional
• Source: Uppsala University
• Contact: Martin F Bjurström, MD, PhD
• Phone: +46739512728
• Email: martin.flores.bjurstrom@uu.se
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Completion date: January 2028