Promoting Sleep to Alleviate Pain - Arthroplasty

Surgery Clinical Trial

— PROSAP-A  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06145516
• Other study ID #: Dnr 2023-03976-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: January 2028

Study information

• Verified date: November 2023
• Source: Uppsala University
• Contact: Martin F Bjurström, MD, PhD
• Phone: +46739512728
• Email: martin.flores.bjurstrom[@]uu.se
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Cognitive 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)
• Sleep education therapy (SET)
Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	Acta Anaesthesiologica Scandinavica Foundation / SSAI, Swedish Government (under the national and regional ALF agreements)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Acute postoperative opioid consumption	Oral morphine equivalents (OMEQs)	Postoperative day (POD) 1 and POD1-7
Secondary	Postoperative sleep quality	insomnia severity index, Pittsburgh sleep quality index	Up to 12 months postoperative
Secondary	Postoperative objective sleep continuity	actigraphy sleep measures	Up to 6 months postoperative
Secondary	Recovery in the acute postoperative phase	Quality of recovery (QoR) 15 score	First 7 postoperative days
Secondary	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
Secondary	Change in cognitive function	Digital cognitive testing (Mindmore platform) incl. memory, attention and processing speed, executive functions	Up to 6 months postoperative
Secondary	Change in anxiety from baseline	Hospital anxiety and depression scale (HADS) anxiety score	Up to 6 months postoperative
Secondary	Change in depression from baseline	HADS depression score	Up to 6 months postoperative
Secondary	Change in quality of life	EuroQol 5 dimension 5 level (EQ-5D-5L), RAND-36	Up to 6 months postoperative
Secondary	Change in health-related function	EQ-5D-5L, RAND-36	Up to 6 months postoperative
Secondary	Change in physical activity	International physical activity questionnaire short form (IPAQ-sf)	Up to 6 months postoperative
Secondary	Change in osteoarthritis-related symptoms	WOMAC OA	Up to 12 months postoperative
Secondary	Change in pain catastrophizing	Pain catastrophizing scale (PCS)	Up to 6 months postoperative
Secondary	Change in kinesiophobia	Tampa scale of kinesiophobia (TSK)	Up to 6 months postoperative
Secondary	Change in subjective pain sensitivity	Pain sensitivity questionnaire (PSQ)	Up to 6 months postoperative
Secondary	Changes in blood biomarkers	Inflammatory mediators, monoamine metabolites etc	Up to 6 months postoperative