Pain in America: A Randomized Controlled Trial

April 24, 2018 updated by: Nkemakolam Egekeze, University of Missouri, Kansas City
Each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. But little evidence exists about orthopaedic patient understanding of the common methods of managing musculoskeletal pain. Therefore, it is our aim to determine which discussion method best improves patient comprehension of common methods of managing pain.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • UMKC Department of Orthopaedic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are new to a discussion about the common methods of managing musculoskeletal pain, over the age of 18, native English speakers

Exclusion Criteria:

  • Patient with a previous orthopaedic surgery or musculoskeletal pain consultation, patients without the capacity to give consent, chronic narcotic users. Patients with a severe mental, visual, auditory or tactile impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
This group will receive a 10 minute discussion
Behavioral: Control
This group will receive a standardized 10 minute discussion.
Active Comparator: Intervention
This group will receive a 10 minute standardized discussion
Behavioral: Intervention
This group will receive a standardized 10 minute discussion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Nkem Musculoskeletal Pain Management Comprehension Test "NMPMCT"
Time Frame: 15 minutes
Validated Questionnaire
15 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Surveys
Time Frame: 5 minutes
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri, Kansas City

Investigators

  • Principal Investigator: Nkem Egekeze, MD, UMKC Department of Orthopaedic Surgery
  • Study Director: Charles Rhoades, MD, UMKC Department of Orthopaedic Surgery
  • Study Director: Mark Bernhardt, MD, UMKC Department of Orthopaedic Surgery
  • Study Director: Karen Williams, PhD, UMKC Department of Orthopaedic Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

March 12, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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