Promoting Sleep to Alleviate Pain - Arthroplasty

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Hip; Insomnia; Surgery; Osteoarthritis, Knee; Pain, Postoperative; Postoperative Complications
• Interventions: Behavioral: Cognitive behavioral therapy for insomnia (CBT-I); Behavioral: Sleep education therapy (SET)

• Registration Number: NCT06145516
• Lead Sponsor: Uppsala University

Brief 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.

Detailed 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 insomnia severity index score \>10 and confirmed DSM-V criteria for persistent insomnia disorder, 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.

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Study Start: 2024-10-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2029-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age ≥18 years
• insomnia severity index score >10
• fulfill DSM-V criteria for persistent insomnia disorder
• scheduled to undergo primary total knee arthroplasty (TKA) or total hip arthroplasty (THA)

Exclusion Criteria

• uncontrolled medical disorders
• nightshift work
• ongoing major depressive disorder, bipolar disorder, psychotic disorder, substance dependence
• current history or high likelihood of primary sleep disorders, including obstructive sleep apnea syndrome, narcolepsy, nocturnal myoclonus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavioral therapy for insomnia (CBT-I)	Cognitive behavioral therapy for insomnia (CBT-I)	The CBT-I treatment will be administered in self-guided digital format over 4 weeks with addition of telehealth video-consultations with a psychologist one time per week. The CBT-I will focus on sleep restriction therapy and stimulus control, which have shown the highest efficacy for sleep improvement among components typically incorporated. A booster session will be provided 1-2 weeks postoperative.
Sleep education therapy (SET)	Sleep education therapy (SET)	The sleep education therapy will be administered in self-guided digital format over 4 weeks with addition of telehealth video-consultations with a research nurse one time per week. The SET will focus on sleep physiology, different sleep disturbances and sleep hygiene measures. A booster session will be provided 1-2 weeks postoperative.

Primary Outcome Measures

Name	Time	Method
Acute postoperative pain intensity	First 7 postoperative days	Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days
Pain intensity 6 months postoperative	6 months postoperative	Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days

Secondary Outcome Measures

Name	Time	Method
Change in cognitive function	Up to 6 months postoperative	Digital cognitive testing (Mindmore platform) incl. memory, attention and processing speed, executive functions
Change in anxiety from baseline	Up to 6 months postoperative	Hospital anxiety and depression scale (HADS) anxiety score
Change in health-related function	Up to 6 months postoperative	EQ-5D-5L, RAND-36
Pre- and acute postoperative change in sleep measures from baseline	Up to 2 weeks postoperative	insomnia severity index, Pittsburgh sleep quality index, actigraphic sleep continuity measures (sleep onset latency, total sleep time, wakefulness after sleep onset, sleep efficiency)
Change in pain measures from baseline	Up to 12 months postoperative	BPI pain severity and pain interference score, QoR-15 pain score, WOMAC OA pain score
Changes in quantitative sensory testing (QST) measures of pain	Up to 6 months postoperative	Pressure pain threshold, temporal summation, conditioned pain modulation, cold pressor test
Acute postoperative opioid consumption	Postoperative day (POD) 1 and POD1-7	Oral morphine mg equivalents (OMEQs)
Postoperative objective sleep continuity	Up to 6 months postoperative	actigraphy sleep measures
Recovery in the acute postoperative phase	First 7 postoperative days	Quality of recovery (QoR) 15 score
Change in osteoarthritis-related symptoms	Up to 12 months postoperative	WOMAC OA
Change in kinesiophobia	Up to 6 months postoperative	Tampa scale of kinesiophobia (TSK)
Change in subjective pain sensitivity	Up to 6 months postoperative	Pain sensitivity questionnaire (PSQ)
Change in depression from baseline	Up to 6 months postoperative	HADS depression score
Change in quality of life	Up to 6 months postoperative	EuroQol 5 dimension 5 level (EQ-5D-5L), RAND-36
Change in physical activity	Up to 6 months postoperative	International physical activity questionnaire short form (IPAQ-sf)
Change in pain catastrophizing	Up to 6 months postoperative	Pain catastrophizing scale (PCS)
Changes in blood biomarkers	Up to 6 months postoperative	Inflammatory mediators, monoamine metabolites etc

Trial Locations

Locations (1)

Department of Surgical Sciences, Uppsala University; 🇸🇪 Uppsala, Uppland, Sweden