Postoperative PainPePSNCT04979429
The Perioperative Pain Self-Management Program Trial
A study testing Perioperative Pain Self-management (PePS) in people with Postoperative Pain, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
This study will trial the impact of teaching surgical patients a pain self-management approach to compliment medical post-surgical pain management. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Perioperative Pain Self-management (PePS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Aug 2021to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2292
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
About this study
Official title: Preventing Chronic Post-Surgical Pain and Prolonged Opioid Use: The Perioperative Pain Self-Management Program
This study will trial the impact of teaching surgical patients a pain self-management approach to compliment medical post-surgical pain management.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Perioperative Pain Self-management (PePS)
- Keywords
- postoperative pain, opioid
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative Pain Self-management (PePS)Behavioural
Also called PePS
4 sessions of telephone CBT-based pain self-management.
| Study group | Role | What they receive |
|---|---|---|
| PePS | Experimental | 4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care. Receives: Behavioral: Perioperative Pain Self-management (PePS) |
| Standard Care | No intervention | Standard perioperative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Surgical Site Pain
The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain.
Measured: 6-months post-surgery
Secondary outcomes (1)
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.
Measured: time to cessation post surgery (weekly phone calls for the first 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start3 Aug 2021
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either receive the pain self-management sessions (PePS) or standard care (SC).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Diana J. Burgess, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979429
- Sponsor's protocol ID
- IIR 20-115
- Acronym
- PePS
- Status last verified
- Jun 2026
- First submitted
- 15 Jul 2021
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35660486
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Chronic Post-Surgical Pain and Prolonged Opioid Use: The Perioperative Pain Self-Management Program
- ClinicalTrials.gov ID
- NCT04979429
- Acronym / sponsor ID
- PePS / IIR 20-115
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either receive the pain self-management sessions (PePS) or standard care (SC).
| Arm | Type | Receives |
|---|---|---|
| PePS | Experimental | Behavioral: Perioperative Pain Self-management (PePS)4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care. |
| Standard Care | No intervention | –Standard perioperative care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative Pain Self-management (PePS)Also: PePS4 sessions of telephone CBT-based pain self-management. | Behavioural | PePS |
Primary outcome
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.
1 secondary outcome
opioid use
Time frame: time to cessation post surgery (weekly phone calls for the first 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Results publication: PubMed 35660486Hadlandsmyth 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana J. Burgess, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative Pain Self-management (PePS) in people with Postoperative Pain, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 6-months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04979429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.