Back to resultsPain in America: A Randomized Controlled Trial
Primary Purpose
Orthopaedic Related Pain (Musculoskeletal Pain)
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Orthopaedic Related Pain (Musculoskeletal Pain)
Eligibility Criteria
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.
Sites / Locations
- UMKC Department of Orthopaedic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control
Intervention
Arm Description
This group will receive a 10 minute discussion
This group will receive a 10 minute standardized discussion
Outcomes
Primary Outcome Measures
The Nkem Musculoskeletal Pain Management Comprehension Test "NMPMCT"
Validated Questionnaire
Secondary Outcome Measures
Surveys
Full Information
NCT ID
NCT02710695
First Posted
March 12, 2016
Last Updated
April 24, 2018
Sponsor
University of Missouri, Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT02710695
Brief Title
Pain in America: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of available time
Study Start Date
March 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri, Kansas City
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopaedic Related Pain (Musculoskeletal Pain)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This group will receive a 10 minute discussion
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
This group will receive a 10 minute standardized discussion
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
This group will receive a standardized 10 minute discussion.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
This group will receive a standardized 10 minute discussion
Primary Outcome Measure Information:
Title
The Nkem Musculoskeletal Pain Management Comprehension Test "NMPMCT"
Description
Validated Questionnaire
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Surveys
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nkem Egekeze, MD
Organizational Affiliation
UMKC Department of Orthopaedic Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Rhoades, MD
Organizational Affiliation
UMKC Department of Orthopaedic Surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mark Bernhardt, MD
Organizational Affiliation
UMKC Department of Orthopaedic Surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karen Williams, PhD
Organizational Affiliation
UMKC Department of Orthopaedic Surgery
Official's Role
Study Director
Facility Information:
Facility Name
UMKC Department of Orthopaedic Surgery
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pain in America: A Randomized Controlled Trial
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