Biopsychosocial Factors' Influence on Shoulder Pain | NCT00187863

Studies
Biopsychosocial Factors' Influence on Shoulder Pain

NCT00187863

Sponsor

University of Florida

Status

Completed

Last Update Posted

Mar 24, 2015Estimated

Enrollment

340Actual

Phase

Not provided

Conditions

Pain

Interventions

pain perception

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2015

Last Update Posted Date

Mar 24, 2015Estimated

Description Module

Brief Summary

The purpose of this study is to determine which factors are associated with the development of chronic shoulder pain and disability.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

340Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise induced pain perception			Behavioral: pain perception
Surgical pain perception			Behavioral: pain perception

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pain perception	Behavioral	pain perception	Exercise induced pain perception Surgical pain perception

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronic shoulder pain and disability

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic shoulder pain and disability

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Z. George, PT, Ph.D.	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UF Orthopaedics and Sports Medicine Institute		Gainesville	Florida	32611	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26945673	Derived	George SZ, Wu SS, Wallace MR, Moser MW, Wright TW, Farmer KW, Greenfield WH 3rd, Dai Y, Li H, Fillingim RB. Biopsychosocial Influence on Shoulder Pain: Influence of Genetic and Psychological Combinations on Twelve-Month Postoperative Pain and Disability Outcomes. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1671-1680. doi: 10.1002/acr.22876. Epub 2016 Oct 6.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms