NCT02338791

Brief Summary

The purpose of this study is to measure the amount of movement between the bones of the shoulder joint when mobilization techniques are applied by a physical therapist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

7 years

First QC Date

January 5, 2015

Last Update Submit

April 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Movement of the humeral head

    The movement of the humeral head in reference to the glenoid fossa is recorded using ultrasound imaging. The amount of movement (as measured in millimeters) between the image taken on rest and the image taken during the manual mobilization is calculated for each direction of manual mobilization. This primary outcome measure is obtained during the performance of the manual mobilization. Subjects are tested and this primary outcome measured during the intervention (manual mobilization) on Day one and, within one week, on Day two. Each subject participates in the study for approximately one week.

    Immediate measurement of humeral head movement concurrent with application of manual mobilization

Secondary Outcomes (1)

  • Force of Mobilization

    Immediate measurement of force used during the application of manual mobilization

Study Arms (1)

Manual Mobilization

EXPERIMENTAL

Grade I, II and III manual mobilizations in the inferior, posterior and distractive directions.

Device: Manual Mobilization

Interventions

Stabilization of the glenoid fossa with movement of the humerus using varying degrees of force as applied by a physical therapist. Subject is positioned with the shoulder in 55 degrees of abduction and 30 degrees of horizontal adduction. Manual force is applied by a physical therapist on the proximal humeral head moving the humeral head posterior, inferior or lateral (distraction). An ultrasound transducer placed over the anterior shoulder joint provides imaging of the humeral head and the glenoid fossa. This manual intervention is repeated three times in each direction on each arm.

Manual Mobilization

Eligibility Criteria

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

You may qualify if:

  • asymptomatic subjects with no history of neck, shoulder, or arm pain; full active pain free range of motion at the cervical spine and shoulders

You may not qualify if:

  • neuromuscular or musculoskeletal disorders; connective tissue disorders such as rheumatoid arthritis; inflammatory conditions such as Crohns disease; Down's syndrome; Marfan's syndrome; medically diagnosed hypermobility; history of neck, shoulder or arm trauma, pain, or surgery including dislocation and rotator cuff tears; pregnancy; and metal implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Study Officials

  • Dexter Witt, DHS

    University of Cincinnati

    PRINCIPAL INVESTIGATOR
  • Nancy Talbott, PhD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 14, 2015

Study Start

April 1, 2012

Primary Completion

March 26, 2019

Study Completion

March 26, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations