Insomnia, Osteoarthritis, Hip, Osteoarthritis, Knee, Pain, Postoperative, Postoperative Complications, Surgery
Conditions
Keywords
osteoarthritis, total knee arthroplasty, total hip arthroplasty, insomnia, sleep disturbance, postoperative pain
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 objective is to evaluate effects of preoperative sleep-promotion on acute 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.
Interventions
BEHAVIORALCognitive behavioral therapy for insomnia (CBT-I)
Hybrid CBT-I (self-guided digital format focusing on sleep restriction therapy and stimulus control + telehealth video-consultations with psychologist)
BEHAVIORALSleep education therapy (SET)
Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* age ≥18 years * insomnia severity index score \>10 * fulfill DSM-V criteria for persistent insomnia disorder * average pain numerical rating scale (NRS) score ≥4 (scale 0 - 10) and/or movement-related pain NRS score ≥4 after 5 minutes walking * scheduled to undergo primary (first-time, i.e., not revision surgery) TKA or THA due to osteoarthritis
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 (other than insomnia), including obstructive sleep apnea syndrome, narcolepsy, nocturnal myoclonus * severely impaired vision (precluding ability to take part of study interventions)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Acute postoperative opioid consumption | Postoperative day (POD) 1 and POD1-7 | Oral morphine mg equivalents (OMEQs) |
| Recovery in the acute postoperative phase | First 7 postoperative days | Quality of recovery (QoR) 15 score |
| Long-term postoperative sleep quality | Up to 12 months postoperative | insomnia severity index |
| Postoperative objective sleep continuity | Up to 6 months postoperative | actigraphic sleep efficiency \[SE\] |
| 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 |
| 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 |
| 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 | Generalized anxiety disorder 7 (GAD-7) score |
| Change in depression from baseline | Up to 6 months postoperative | Patient health questionnaire 9 (PHQ-9) score |
| Change in quality of life | Up to 6 months postoperative | EuroQol 5 dimension 5 level (EQ-5D-5L), RAND-36 |
| Change in health-related function | Up to 6 months postoperative | EQ-5D-5L, RAND-36 |
| Change in osteoarthritis-related symptoms | Up to 12 months postoperative | WOMAC OA |
Countries
Sweden
Contacts
CONTACTMartin F Bjurström, MD, PhD
PRINCIPAL_INVESTIGATORMartin F Bjurström, MD, PhD
Uppsala University / Uppsala University Hospital
Outcome results
None listed