Disorder of ShoulderNCT02338791
Rehabilitative Ultrasound Imaging: Measurements of Articular Movement of the Shoulder
A study testing Manual Mobilization in people with Disorder of Shoulder, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Shoulder
- What is being tested?
- Manual Mobilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 26 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- asymptomatic subjects with no history of neck, shoulder, or arm pain; full active pain free range of motion at the cervical spine and shoulders
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Disorder of Shoulder
- Being tested
- Manual Mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual MobilizationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual Mobilization | Experimental | Grade I, II and III manual mobilizations in the inferior, posterior and distractive directions. Receives: Device: Manual Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate measurement of humeral head movement concurrent with application of manual mobilization
Secondary outcomes (1)
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.
Measured: Immediate measurement of force used during the application of manual mobilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startApr 2012
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ShoulderStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dexter Witt, University of Cincinnati
- Investigators
- Dexter Witt, DHS, Principal investigator, University of CincinnatiNancy Talbott, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338791
- Sponsor's protocol ID
- 2013-1211
- Status last verified
- Apr 2019
- First submitted
- 5 Jan 2015
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitative Ultrasound Imaging: Measurements of Articular Movement of the Shoulder
- ClinicalTrials.gov ID
- NCT02338791
- Acronym / sponsor ID
- 2013-1211
- Conditions
- Disorder of Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manual Mobilization | Experimental | Device: Manual MobilizationGrade I, II and III manual mobilizations in the inferior, posterior and distractive directions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- asymptomatic subjects with no history of neck, shoulder, or arm pain; full active pain free range of motion at the cervical spine and shoulders
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual MobilizationStabilization 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. | Device | Manual Mobilization |
Primary outcome
Movement of the humeral head
Time frame: Immediate measurement of humeral head movement concurrent with application of manual mobilization
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.
1 secondary outcome
Force of Mobilization
Time frame: Immediate measurement of force used during the application of manual mobilization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dexter Witt, DHS principal investigator
University of Cincinnati
Nancy Talbott, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Mobilization in people with Disorder of Shoulder, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement of the humeral head (time frame: Immediate measurement of humeral head movement concurrent with application of manual mobilization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.