Rehabilitative Ultrasound Imaging: Measurements of Articular Movement of the Shoulder

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.

Study Overview

• Status: Completed
• Conditions: Disorder of Shoulder
• Intervention / Treatment: Device: Manual Mobilization

Detailed Description

The purpose of this study is to image the articular joint movement of the glenohumeral joint utilizing ultrasound imaging (USI). Specific aims include: 1) measurement of the distance between the articular surfaces at rest; 2) measurement of the distance between the articular surfaces during manually applied glides of those surfaces; and 3) analysis of any association between the amount of glide and reported joint mobility, force application, or joint position.

Subjects will be recruited from a population of convenience. After consenting to participate, eligible subjects will complete a demographic questionnaire and pretesting of scapular and shoulder mobility. Two days of testing will be scheduled. On the first day, three grades of glenohumeral mobilization will be applied in the following directions: distraction, posterior and inferior. A handheld dynamometer will measure force; ultrasound imaging will record glenohumeral joint position. Each grade and direction will be repeated three times on the right and the left shoulder. On the second day, the mobilizations will be repeated. Measurements of humeral movement will be calculated from the ultrasound images.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Manual Mobilization; Grade I, II and III manual mobilizations in the inferior, posterior and distractive directions.

Device: Manual Mobilization; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Force of Mobilization	Amount of force used during the application of grade I, grade II and grade III mobilizations. The maximal force used during the performance of the manual mobilization (as measured in Newtons) is recorded using a hand held dynamometer as the mobilization is performed. Subjects are tested and this secondary 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 force used during the application of manual mobilization

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Dexter Witt, DHS, University of Cincinnati; Principal Investigator: Nancy Talbott, PhD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): March 26, 2019
• Study Completion (Actual): March 26, 2019

Study Registration Dates

• First Submitted: January 5, 2015
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2013-1211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No