Promoting Sleep to Alleviate Pain - Arthroplasty

NCT06145516 | Recruiting

• 1 other identifier: Dnr 2023-03976-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

osteoarthritis; total knee arthroplasty; total hip arthroplasty; insomnia; sleep disturbance; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Acute postoperative pain intensity

  Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days

  First 7 postoperative days

Secondary Outcomes (14)

• Pre- and acute postoperative change in sleep measures from baseline

  Up to 2 weeks postoperative

• Acute postoperative opioid consumption

  Postoperative day (POD) 1 and POD1-7

• Recovery in the acute postoperative phase

  First 7 postoperative days

• Long-term postoperative sleep quality

  Up to 12 months postoperative

• Postoperative objective sleep continuity

  Up to 6 months postoperative

Other Outcomes (7)

• Change in physical activity

  Up to 6 months postoperative

• Change in pain catastrophizing

  Up to 6 months postoperative

• Change in kinesiophobia

  Up to 6 months postoperative

Study Arms (2)

Cognitive behavioral therapy for insomnia (CBT-I)

EXPERIMENTAL

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)

Sleep education therapy (SET)

ACTIVE COMPARATOR

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)

Interventions

Cognitive behavioral therapy for insomnia (CBT-I) BEHAVIORAL

Hybrid CBT-I (self-guided digital format focusing on sleep restriction therapy and stimulus control + telehealth video-consultations with psychologist)

Cognitive behavioral therapy for insomnia (CBT-I)

Sleep education therapy (SET) BEHAVIORAL

Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse

Sleep education therapy (SET)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Department of Surgical Sciences, Uppsala University

Uppsala, Uppland, 75185, Sweden

RECRUITING

Related Publications (1)

• Bjurstrom MF, Bothelius K, Maathz P, Jernelov S, Kraepelien M, Rosenstrom AHC, Niklasson A, Smith MT, Olmstead R, Irwin MR, Finan PH, Kosek E. Randomised, controlled clinical trial evaluating the effects of preoperative insomnia treatment on postoperative pain control and recovery: a protocol for the Promoting Sleep to Alleviate Pain-Arthroplasty (PROSAP-A) trial. BMJ Open. 2025 Jul 30;15(7):e099785. doi: 10.1136/bmjopen-2025-099785.

  PMID: 40738630 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Sleep Initiation and Maintenance Disorders; Pain, Postoperative; Postoperative Complications; Osteoarthritis; Parasomnias

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Martin F Bjurström, MD, PhD

  Uppsala University / Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin F Bjurström, MD, PhD

CONTACT

+46739512728; martin.flores.bjurstrom@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)