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Characterization of Postoperative Pain in Shoulder Arthroscopy and Knee Arthroscopy and Assessment of the Defense and Veterans Pain Rating Scale for Persistent Pot-Surgical Pain (Purple Rain)

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ClinicalTrials.gov Identifier: NCT03047434
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management

Brief Summary:

2.1Purpose: The purpose of this study is to describe the chronology of postoperative pain in patients undergoing shoulder, knee, ankle arthroscopy. Further, within this population the predictive validity of the Defense and Veterans Pain Rating Scale will be assessed for persistent post surgical pain.

2.2 Research Design: 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.

2.3 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.


Condition or disease
Post Surgical Pain

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Study Type : Observational
Estimated 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 Pot-Surgical Pain
Actual Study Start Date : November 9, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019



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 [ 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.


  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. [ 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?



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 1. Patients undergoing the following surgeries i. Total Knee Arthroplasty ii. Total Hip Arthroplasty ii.2. DEERS eligible

Exclusion Criteria:

  • 1. Younger than 18 2. Refuses participation 3. Cannot understand English 4. Has cognitive deficiencies 5. Ambulatory surgical statuswhere they go home same day 6. Revision Total Knee or Total Hip Arthroplasty

Information from the National Library of Medicine

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


Contacts
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Contact: Megan Vaughan, BSN 301-816-4718 mvaughan@dvcipm.org

Locations
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United States, Maryland
WRNMMC Recruiting
Bethesda, Maryland, United States
Contact: Megan Vaughan         
Sponsors and Collaborators
Defense and Veterans Center for Integrative Pain Management

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Responsible Party: Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier: NCT03047434     History of Changes
Other Study ID Numbers: 413667
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Shoulder Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases