Characterization of PostOp Pain in Shoulder and Knee Arthroscopy (PurpleRain)
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|ClinicalTrials.gov Identifier: NCT03047434|
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : August 13, 2019
|Condition or disease|
|Post Surgical Pain|
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 Type :||Observational|
|Estimated Enrollment :||250 participants|
|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|
|Actual Study Start Date :||November 9, 2016|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- 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?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047434
|Contact: Mary McDuffie, BSNemail@example.com|
|United States, Maryland|
|Bethesda, Maryland, United States, 20889|
|Contact: Mary McDuffie|
|Principal Investigator:||Harold Gelfand||Walter Reed National Military Medical Center|