Characterization of PostOp Pain in Shoulder and Knee Arthroscopy (PurpleRain)

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.

Study Overview

• Status: Completed
• Conditions: Post Surgical Pain
• Intervention / Treatment: Other

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 Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • WRNMMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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?	3-months and 6-months post-surgery

Collaborators and Investigators

• Sponsor: Defense and Veterans Center for Integrative Pain Management
• Investigators: Principal Investigator: Harold Gelfand, Walter Reed National Military Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2016
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain, Postoperative; Shoulder Pain
• Other Study ID Numbers: 413667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No