The Perioperative Pain Self-Management Program Trial

Not Applicable

Active, not recruiting

• Conditions: Postoperative Pain
• Interventions: Behavioral: Perioperative Pain Self-management (PePS)

• Registration Number: NCT04979429
• Lead Sponsor: VA Office of Research and Development

Brief Summary

This study will trial the impact of teaching surgical patients a pain self-management approach to compliment medical post-surgical pain management.

Detailed Description

Surgery can precipitate the development of both chronic pain and long-term opioid use. There is a need for strategies to augment perioperative pharmacotherapeutic management of pain with non-pharmacologic strategies to prevent long-term sequelae. Psychological interventions such as cognitive behavioral therapy (CBT) can effectively reduce distress and improve functioning among patients with chronic pain. While CBT has been used extensively in patients with established chronic pain, it has not been used as a preventive intervention targeting the transition from acute to chronic postsurgical pain. The Perioperative Pain Self-management (PePS) program has the potential to reduce the incidence of chronic post-surgical pain and long-term opioid use among Veterans. This study will: Examine the efficacy of PePS compared to standard care on 6-month pain (primary outcome), mood and functioning outcomes as well as time to post-surgical opioid and other analgesic use cessation.

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-28
• Study Start: 2021-08-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-07-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

• scheduled for total hip, knee, or shoulder joint arthroplasty through the Iowa City, IA, Des Moines, IA, Minneapolis, IA, or Milwaukee WI, VA medical centers

Exclusion Criteria

• inability to complete study forms/procedures because of a language/literacy barrier
• active bipolar or psychotic disorder
• history of brain injury
• dementia
• CBT therapy within the past year
• lack of access to a telephone for PePS sessions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PePS	Perioperative Pain Self-management (PePS)	4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care.

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	6-months post-surgery	Surgical Site Pain; The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain.

Secondary Outcome Measures

Name	Time	Method
opioid use	time to cessation post surgery (weekly phone calls for the first 6 weeks)	Time to opioid cessation following surgery: daily opioid use will be collected via weekly phone calls for the first 6 weeks post-surgery.

Trial Locations

Locations (2)

Iowa City VA Health Care System, Iowa City, IA; 🇺🇸 Iowa City, Iowa, United States

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States