Post Surgical PainPurpleRainNCT03047434
Characterization of PostOp Pain in Shoulder and Knee Arthroscopy
An observational study of Post Surgical Pain, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
Trial summary
The purpose of this study is to describe the chronology of post operative pain in patients undergoing total knee arthroplasty and total hip arthroplasty. Further, within this population the predictive validity of the Defense and Veterans Pain Rating Scale will be assessed for persistent post surgical pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Surgical Pain
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2016to 24 Jan 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Male and female military health care beneficiaries age 18 years and older presenting any of the following surgeries: total knee arthroplasty and total hip arthroplasty. 2. The recruitment and participation in this study will have minimal impact on surrounding health care activities. This study is measuring pain in a more specific manner than usual to describe the perioperative pain experience and evaluate the predictive capability of the DVPRS. Measurements in this study will not be used to make therapeutic decisions. Participants will be screened from the Surgical Scheduling System (S3) and joint arthroplasty surgeon's scheduling nurse prior to surgery and approached upon their preoperative visit with their surgeon.
Who may be able to join
- Patients undergoing the following surgeries: Total Knee Arthroscopy, Total Hip Arthroscopy.
- DEERS eligible
Who cannot join
- Younger than 18
- Refuses participation
- Cannot understand English
- Has cognitive deficiencies
- Ambulatory surgical status where they go home same day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Postoperative Pain in Shoulder Arthroscopy and Knee Arthroscopy and Assessment of the Defense and Veterans Pain Rating Scale for Persistent Post-Surgical Pain
The purpose of this study is to describe the chronology of post operative pain in patients undergoing total knee arthroplasty and total hip arthroplasty. Further, within this population the predictive validity of the Defense and Veterans Pain Rating Scale will be assessed for persistent post surgical pain.
Read the detailed description
This is a prospective descriptive correlational design looking to characterize postoperative pain variables across various procedures that historically have significant levels of persistent post-surgical pain. Further, bivariate correlations at different time points will be examined to see how DVPRS along with Pain Assessment Screening Tool and Outcomes Registry (PASTOR) correlates with other measures.
Methodology/Technical Approach A total goal of 250 participants will be queried regarding their postoperative pain experience following shoulder arthroscopy and knee arthroscopy. Descriptive multidimensional tools (the DVPRS and the electronic Pain Assessment Screening Tool and Outcomes Registry (PASTOR)) will be used preoperative either during their preoperative surgical visit or the day of surgery and extending to 6 months postoperatively. As these tools have been utilized in previous studies for the prediction of persistent post surgical pain, the DVPRS will additionally be evaluated for its predictive validity as it is a short, easy-to-administer, bedside tool.
- Conditions
- Post Surgical Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the chronology/natural history of the postoperative pain experience in patients undergoing shoulder arthroscopy, knee, ankle arthroscopy in a multidimensional fashion from the immediate postoperative phase until 6 months post-surgery
Describe biopsychosocial functioning, as indicated by PROMIS domain scales and the DVPRS, at each time point, as well as longitudinal, polynomial data patterns for the aggregated sample.
Examine whether longitudinal patterns vary according to surgical factors (e.g. procedure type, type of regional intervention received).
Identify factors associated with low functioning and persistent opioid use at 3-months and 6-months post-surgery.
Measured: 3-months and 6-months post-surgery
To assess the predictive validity of the DVPRS and PASTOR for persistent post-surgical pain at 3 and 6 months in patients undergoing the above surgical procedures.
) When accounting for baseline levels, does postoperative Day 7 DVPRS scores predict persistent post- surgical pain at 3 months, as defined as 1 SD worse functioning on PROMIS Pain Interference? b) When accounting for baseline levels, does postoperative Day 7 DVPRS scores predict persistent post-surgical pain at 3 months, as defined as 1 SD worse functioning on PROMIS Neuropathic? c) What are the optimal cut-offs for the DVPRS at Day 7 in predicting persistent post-surgical pain at 3 months, as defined as 1 SD worse functioning on PROMIS Pain Interference?
Measured: 3-months and 6-months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start9 Nov 2016
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
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 Post Surgical PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harold Gelfand, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047434
- Sponsor's protocol ID
- 413667
- Acronym
- PurpleRain
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giordano NA, Kent M, Buckenmaier CC 3rd, Mauntel TC, Dickens JF, Millington M, Highland KB. A Longitudinal Comparison of Patient-Reported Outcomes Measurement Information System to Legacy Scales in Knee and Shoulder Arthroscopy Patients. Arthroscopy. 2021 Jan;37(1):185-194.e2. doi: 10.1016/j.arthro.2020.07.026. Epub 2020 Jul 25.
PubMed 32721547
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Postoperative Pain in Shoulder Arthroscopy and Knee Arthroscopy and Assessment of the Defense and Veterans Pain Rating Scale for Persistent Post-Surgical Pain
- ClinicalTrials.gov ID
- NCT03047434
- Acronym / sponsor ID
- PurpleRain / 413667
- Conditions
- Post Surgical Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 9 Feb 2017 (estimated)
- 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.
The purpose of this study is to describe the chronology of post operative pain in patients undergoing total knee arthroplasty and total hip arthroplasty. Further, within this population the predictive validity of the Defense and Veterans Pain Rating Scale will be assessed for persistent post surgical pain.
Detailed description
This is a prospective descriptive correlational design looking to characterize postoperative pain variables across various procedures that historically have significant levels of persistent post-surgical pain. Further, bivariate correlations at different time points will be examined to see how DVPRS along with Pain Assessment Screening Tool and Outcomes Registry (PASTOR) correlates with other measures.
Methodology/Technical Approach A total goal of 250 participants will be queried regarding their postoperative pain experience following shoulder arthroscopy and knee arthroscopy. Descriptive multidimensional tools (the DVPRS and the electronic Pain Assessment Screening Tool and Outcomes Registry (PASTOR)) will be used preoperative either during their preoperative surgical visit or the day of surgery and extending to 6 months postoperatively. As these tools have been utilized in previous studies for the prediction of persistent post surgical pain, the DVPRS will additionally be evaluated for its predictive validity as it is a short, easy-to-administer, bedside tool.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Male and female military health care beneficiaries age 18 years and older presenting any of the following surgeries: total knee arthroplasty and total hip arthroplasty. 2. The recruitment and participation in this study will have minimal impact on surrounding health care activities. This study is measuring pain in a more specific manner than usual to describe the perioperative pain experience and evaluate the predictive capability of the DVPRS. Measurements in this study will not be used to make therapeutic decisions. Participants will be screened from the Surgical Scheduling System (S3) and joint arthroplasty surgeon's scheduling nurse prior to surgery and approached upon their preoperative visit with their surgeon.
Key inclusion criteria (2 listed)
- Patients undergoing the following surgeries: Total Knee Arthroscopy, Total Hip Arthroscopy.
- DEERS eligible
Key exclusion criteria (5 listed)
- Younger than 18
- Refuses participation
- Cannot understand English
- Has cognitive deficiencies
- Ambulatory surgical status where they go home same day.
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 |
|---|---|---|
| Other | – |
Primary outcome
To characterize the chronology/natural history of the postoperative pain experience in patients undergoing shoulder arthroscopy, knee, ankle arthroscopy in a multidimensional fashion from the immediate postoperative phase until 6 months post-surgery
Time frame: 3-months and 6-months post-surgery
Describe biopsychosocial functioning, as indicated by PROMIS domain scales and the DVPRS, at each time point, as well as longitudinal, polynomial data patterns for the aggregated sample. Examine whether longitudinal patterns vary according to surgical factors (e.g. procedure type, type of regional intervention received). Identify factors associated with low functioning and persistent opioid use at 3-months and 6-months post-surgery.
To assess the predictive validity of the DVPRS and PASTOR for persistent post-surgical pain at 3 and 6 months in patients undergoing the above surgical procedures.
Time frame: 3-months and 6-months post-surgery
) When accounting for baseline levels, does postoperative Day 7 DVPRS scores predict persistent post- surgical pain at 3 months, as defined as 1 SD worse functioning on PROMIS Pain Interference? b) When accounting for baseline levels, does postoperative Day 7 DVPRS scores predict persistent post-surgical pain at 3 months, as defined as 1 SD worse functioning on PROMIS Neuropathic? c) What are the optimal cut-offs for the DVPRS at Day 7 in predicting persistent post-surgical pain at 3 months, as defined as 1 SD worse functioning on PROMIS Pain Interference?
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 17 Feb 2020.
- Derived from this study: PubMed 32721547Giordano NA, Kent M, Buckenmaier CC 3rd, Mauntel TC, Dickens JF, Millington M, Highland KB. A Longitudinal Comparison of Patient-Reported Outcomes Measurement Information System to Legacy Scales in Knee and Shoulder Arthroscopy Patients. Arthroscopy. 2021 Jan;37(1):185-194.e2. doi: 10.1016/j.arthro.2020.07.026. Epub 2020 Jul 25.
- 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.
Harold Gelfand principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Surgical Pain, run by Defense and Veterans Center for Integrative Pain Management at 1 site 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 2 inclusion and 5 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To characterize the chronology/natural history of the postoperative pain experience in patients undergoing shoulder arthroscopy, knee, ankle arthroscopy in a multidimensional fashion from the immediate postoperative phase until 6 months post-surgery (time frame: 3-months and 6-months post-surgery). The study lists 2 primary outcomes in all. 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 NCT03047434, 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 17 Feb 2020.