Promoting Sleep to Alleviate Pain - Arthroplasty

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Knee, Osteoarthritis, Hip, Insomnia, Surgery, Pain, Postoperative, Postoperative Complications

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)
* Behavioral: Sleep education therapy (SET)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥18 years insomnia severity index score ≥15 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioral therapy for insomnia (CBT-I)<br>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. | Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)<br>* Hybrid CBT-I (self-guided digital format focusing on sleep restriction therapy and stimulus control + telehealth video-consultations with psychologist)<br>|
| Active Comparator: Sleep education therapy (SET)<br>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. | Behavioral: Sleep education therapy (SET)<br>* Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain measures from baseline | preoperative post-intervention (brief pain inventory (BPI) pain severity and pain interference score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC OA) pain score), acute postoperative (QoR-15 pain score, BPI pain severity and pain interference score), long-term postoperative pain control (BPI pain severity and pain interference score, WOMAC OA pain score) | Up to 12 months postoperative | 
| Pre- and acute postoperative change in sleep measures from baseline | insomnia severity index (ISI) score, actigraphic sleep continuity measures (sleep onset latency, total sleep time, wakefulness after sleep onset, sleep efficiency) | Up to 2 weeks postoperative | 
| Acute postoperative opioid consumption | Oral morphine equivalents (OMEQs) | Postoperative day (POD) 1 and POD1-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative sleep quality | insomnia severity index, Pittsburgh sleep quality index | Up to 12 months postoperative | 
| Postoperative objective sleep continuity | actigraphy sleep measures | Up to 6 months postoperative | 
| Recovery in the acute postoperative phase | Quality of recovery (QoR) 15 score | First 7 postoperative days | 
| Changes in quantitative sensory testing (QST) measures of pain | Pressure pain threshold, temporal summation, conditioned pain modulation, cold pressor test | Up to 6 months postoperative | 
| Change in cognitive function | Digital cognitive testing (Mindmore platform) incl. memory, attention and processing speed, executive functions | Up to 6 months postoperative | 
| Change in anxiety from baseline | Hospital anxiety and depression scale (HADS) anxiety score | Up to 6 months postoperative | 
| Change in depression from baseline | HADS depression score | Up to 6 months postoperative | 
| Change in quality of life | EuroQol 5 dimension 5 level (EQ-5D-5L), RAND-36 | Up to 6 months postoperative | 
| Change in health-related function | EQ-5D-5L, RAND-36 | Up to 6 months postoperative | 
| Change in physical activity | International physical activity questionnaire short form (IPAQ-sf) | Up to 6 months postoperative | 
| Change in osteoarthritis-related symptoms | WOMAC OA | Up to 12 months postoperative | 
| Change in pain catastrophizing | Pain catastrophizing scale (PCS) | Up to 6 months postoperative | 
| Change in kinesiophobia | Tampa scale of kinesiophobia (TSK) | Up to 6 months postoperative | 
| Change in subjective pain sensitivity | Pain sensitivity questionnaire (PSQ) | Up to 6 months postoperative | 
| Changes in blood biomarkers | Inflammatory mediators, monoamine metabolites etc | Up to 6 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, total knee arthroplasty, total hip arthroplasty, insomnia, sleep disturbance, postoperative pain