NCT02710695

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

2.1 years

First QC Date

March 12, 2016

Last Update Submit

April 24, 2018

Conditions

Orthopaedic Related Pain (Musculoskeletal Pain)

Outcome Measures

Primary Outcomes (1)

  • The Nkem Musculoskeletal Pain Management Comprehension Test "NMPMCT"

    Validated Questionnaire

    15 minutes

Secondary Outcomes (1)

  • Surveys

    5 minutes

Study Arms (2)

Control

ACTIVE COMPARATOR

This group will receive a 10 minute discussion

Behavioral: Control

Intervention

ACTIVE COMPARATOR

This group will receive a 10 minute standardized discussion

Behavioral: Intervention

Interventions

ControlBEHAVIORAL

This group will receive a standardized 10 minute discussion.

Control
InterventionBEHAVIORAL

This group will receive a standardized 10 minute discussion

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMKC Department of Orthopaedic Surgery

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Methods

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Nkem Egekeze, MD

    UMKC Department of Orthopaedic Surgery

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Research Fellow

Study Record Dates

First Submitted

March 12, 2016

First Posted

March 17, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

US(1)