Biopsychosocial Factors' Influence on Shoulder Pain

March 20, 2015 updated by: University of Florida
The purpose of this study is to determine which factors are associated with the development of chronic shoulder pain and disability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine which factors are associated with the development of chronic shoulder pain and disability. Previous studies have suggested that specific genes influence pain perception. Other studies have suggested that specific psychological factors influence pain perception. We plan to investigate both of these factors to see if they contribute to the development of chronic shoulder pain and disability.

Study Type

Observational

Enrollment (Actual)

340

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
    • Florida
      • Gainesville, Florida, United States, 32611
        • UF Orthopaedics and Sports Medicine Institute

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic shoulder pain and disability

Description

Inclusion Criteria:

  • chronic shoulder pain and disability

Exclusion Criteria:

  • none

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exercise induced pain perception
Behavioral: pain perception
pain perception
Surgical pain perception
Behavioral: pain perception
pain perception

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: Baseline to 12 months
Measurement using the quick DASH
Baseline to 12 months
Pain intensity
Time Frame: Baseline to 12 months
Measured by the Brief Pain Inventory
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical impairment
Time Frame: Baseline to 12 months
Measured shoulder range of motion
Baseline to 12 months
Activity evoked pain
Time Frame: Baseline to 12 months
Measured by Numerical Rating Scale with shoulder movement
Baseline to 12 months

Collaborators and Investigators

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

Sponsor

University of Florida

Investigators

  • Principal Investigator: Steven Z. George, PT, Ph.D., University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2005

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61-2005

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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