PurpleRain: Characterization of PostOp Pain in Shoulder and Knee Arthroscopy

Sponsor
Defense and Veterans Center for Integrative Pain Management (Other)
Overall Status
Completed
CT.gov ID
NCT03047434
Collaborator
(none)
250
1
38.5
6.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    250 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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 :
    Nov 9, 2016
    Actual Primary Completion Date :
    Jan 24, 2020
    Actual Study Completion Date :
    Jan 24, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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 [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.

    2. 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. [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?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Patients undergoing the following surgeries: Total Knee Arthroscopy, Total Hip Arthroscopy.

    2. DEERS eligible

    Exclusion Criteria:
    1. Younger than 18

    2. Refuses participation

    3. Cannot understand English

    4. Has cognitive deficiencies

    5. Ambulatory surgical status where they go home same day.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 WRNMMC Bethesda Maryland United States 20889

    Sponsors and Collaborators

    • Defense and Veterans Center for Integrative Pain Management

    Investigators

    • Principal Investigator: Harold Gelfand, Walter Reed National Military Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Defense and Veterans Center for Integrative Pain Management
    ClinicalTrials.gov Identifier:
    NCT03047434
    Other Study ID Numbers:
    • 413667
    First Posted:
    Feb 9, 2017
    Last Update Posted:
    Feb 17, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2020