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Completed

NCT Number: NCT04979429

The Perioperative Pain Self-Management Program Trial

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iowa City VA Health Care System, Iowa City, IA, Iowa City, Iowa, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perioperative Pain Self-management (PePS)

Behavioral

4 sessions of telephone CBT-based pain self-management.

Other names: PePS

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: 6-months post-surgery

    Surgical Site Pain

    The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain.

Secondary outcomes

  1. opioid use

    Time frame: 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.

Other outcomes

  1. Patient Health Questionnaire 8-item version (PHQ-8)

    Time frame: Change between pre-surgery and 6-months post-surgery

    A measure of depressive symptoms. Scores range from 0-24 with higher scores indicating more depressive symptoms.

  2. General Anxiety Disorder Scale: 7-item (GAD-7)

    Time frame: Change between pre-surgery and 6-months post-surgery

    A measure of anxious symptoms. Scores range from 0-21 with higher scores indicating more anxious symptoms.

  3. Pain Disability Index (PDI)

    Time frame: Change between pre-surgery and 6-months post-surgery

    A measure of pain-related functioning. Scores range from 0-70 with higher scores indicating greater pain-related disability.

  4. Brief pain inventory

    Time frame: 6 months post-surgery

    Generalized body pain intensity and pain interference. Scores range from 0-10 with higher scores indicating more pain severity and interference.

  5. Other analgesic use

    Time frame: time to cessation post-surgery (weekly phone calls for the first 6 weeks post-surgery)

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: PePS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2021
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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