Clinical trial NCT06145516: Promoting Sleep to Alleviate Pain - Arthroplasty
Official title: Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Insomnia
Surgery
Pain, Postoperative
Postoperative Complications
Keywords: osteoarthritis
total knee arthroplasty
total hip arthroplasty
insomnia
sleep disturbance
postoperative pain
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute postoperative pain intensity
timeFrame: First 7 postoperative days
measure: Pain intensity 6 months postoperative
timeFrame: 6 months postoperative
Secondary outcomes:
measure: Change in pain measures from baseline
timeFrame: Up to 12 months postoperative
measure: Pre- and acute postoperative change in sleep measures from baseline
timeFrame: Up to 2 weeks postoperative
measure: Acute postoperative opioid consumption
timeFrame: Postoperative day (POD) 1 and POD1-7
measure: Postoperative objective sleep continuity
timeFrame: Up to 6 months postoperative
measure: Recovery in the acute postoperative phase
timeFrame: First 7 postoperative days
measure: Changes in quantitative sensory testing (QST) measures of pain
timeFrame: Up to 6 months postoperative
measure: Change in cognitive function
timeFrame: Up to 6 months postoperative
measure: Change in anxiety from baseline
timeFrame: Up to 6 months postoperative
measure: Change in depression from baseline
timeFrame: Up to 6 months postoperative
measure: Change in quality of life
timeFrame: Up to 6 months postoperative
measure: Change in health-related function
timeFrame: Up to 6 months postoperative
measure: Change in physical activity
timeFrame: Up to 6 months postoperative
measure: Change in osteoarthritis-related symptoms
timeFrame: Up to 12 months postoperative
measure: Change in pain catastrophizing
timeFrame: Up to 6 months postoperative
measure: Change in kinesiophobia
timeFrame: Up to 6 months postoperative
measure: Change in subjective pain sensitivity
timeFrame: Up to 6 months postoperative
measure: Changes in blood biomarkers
timeFrame: Up to 6 months postoperative
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of Surgical Sciences, Uppsala University
state: Uppland
Study officials:
affiliation: Uppsala University / Uppsala University Hospital
name: Martin F Bjurström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: