The Perioperative Pain Self-Management Program Trial

Postoperative Pain Clinical Trial

— PePS  

Official title:

Preventing Chronic Post-Surgical Pain and Prolonged Opioid Use: The Perioperative Pain Self-Management Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979429
• Other study ID #: IIR 20-115
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2021
• Est. completion date: July 30, 2025

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Katherine E Hadlandsmyth, PhD MA MS
• Phone: (319) 594-1885
• Email: Katherine.Hadlandsmyth[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Behavioral:
• Perioperative Pain Self-management (PePS)
4 sessions of telephone CBT-based pain self-management.

Locations

Country	Name	City	State
United States	Iowa City VA Health Care System, Iowa City, IA	Iowa City	Iowa
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hadlandsmyth K, Burgess DJ, Leparski RF, Odom AS, Campbell EJ, Obrecht AA, Adamowicz JL, Cho H, Steffensmeier KS, Johnson NL, Richards CC, Vander Weg MW, Lund BC, Yoon P, Mosher HJ. The Perioperative Pain Self-Management (PePS) randomized controlled trial — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Health Questionnaire 8-item version (PHQ-8)	A measure of depressive symptoms. Scores range from 0-24 with higher scores indicating more depressive symptoms.	Change between pre-surgery and 6-months post-surgery
Other	General Anxiety Disorder Scale: 7-item (GAD-7)	A measure of anxious symptoms. Scores range from 0-21 with higher scores indicating more anxious symptoms.	Change between pre-surgery and 6-months post-surgery
Other	Pain Disability Index (PDI)	A measure of pain-related functioning. Scores range from 0-70 with higher scores indicating greater pain-related disability.	Change between pre-surgery and 6-months post-surgery
Other	Brief pain inventory	Generalized body pain intensity and pain interference. Scores range from 0-10 with higher scores indicating more pain severity and interference.	6 months post-surgery
Other	Other analgesic use	Time to cessation of other analgesics following surgery: daily analgesic use will be collected via weekly phone calls for the first 6 weeks post-surgery.	time to cessation post-surgery (weekly phone calls for the first 6 weeks post-surgery)
Primary	Numeric Pain Rating Scale	Surgical Site Pain; The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain.	6-months post-surgery
Secondary	opioid use	Time to opioid cessation following surgery: daily opioid use will be collected via weekly phone calls for the first 6 weeks post-surgery.	time to cessation post surgery (weekly phone calls for the first 6 weeks)