Clinical trial NCT04979429: The Perioperative Pain Self-Management Program Trial
Official title: Preventing Chronic Post-Surgical Pain and Prolonged Opioid Use: The Perioperative Pain Self-Management Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative pain
opioid
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-07-28
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either receive the pain self-management sessions (PePS) or standard care (SC).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 6-months post-surgery
Secondary outcomes:
measure: opioid use
timeFrame: time to cessation post surgery (weekly phone calls for the first 6 weeks)
Other outcomes:
measure: Patient Health Questionnaire 8-item version (PHQ-8)
timeFrame: Change between pre-surgery and 6-months post-surgery
measure: General Anxiety Disorder Scale: 7-item (GAD-7)
timeFrame: Change between pre-surgery and 6-months post-surgery
measure: Pain Disability Index (PDI)
timeFrame: Change between pre-surgery and 6-months post-surgery
measure: Brief pain inventory
timeFrame: 6 months post-surgery
measure: Other analgesic use
timeFrame: time to cessation post-surgery (weekly phone calls for the first 6 weeks post-surgery)
Locations:
city: Iowa City
country: United States
facility: Iowa City VA Health Care System, Iowa City, IA
state: Iowa
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Iowa City VA Health Care System, Iowa City, IA
name: Katherine E Hadlandsmyth, PhD MA MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 protocol: Preventing chronic post-surgical pain and prolonged opioid use. Contemp Clin Trials. 2022 Jul;118:106810. doi: 10.1016/j.cct.2022.106810. Epub 2022 May 31.