Rotator Cuff TearsNCT04571268
Motions of the Bones and Activation of the Muscles of the Shoulder Girdle During Basic and Common Arm Movement
An observational study of Rotator Cuff Tears, run by More Foundation at 1 site in United States.
Trial summary
A comprehensive understanding of healthy shoulder motion is a valuable contribution to the academic literature and provides a basis of comparison for various shoulder pathologies and treatments. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2019to 30 Dec 2022
- Phase
- Observational
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between 50 and 70 years old, inclusive, who present with chronic right shoulder pain with a documented right rotator cuff tear will be screened for eligibility and participation. Rotator cuff tear subjects will be recruited under consultation with physicians from their patient populations. Patient charts will be assessed by study investigators to ensure they meet inclusion/exclusion criteria prior to consent. Healthy subjects will be recruited by flyer and word of mouth from the surrounding general population. Healthy subjects will be of similar demographics to the rotator cuff tear subjects.
Who may be able to join
- All subjects
- Right hand dominant
- English speaking
- Subjects who have read and signed IRB approved informed consent for the study.
- RCT subjects:
- Chronic right-side side shoulder pain with documented rotator cuff tear involving 2 or more tendons, and greater than 5cm as diagnosed by MRI
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- Exhibit right rotator cuff disfunction without corresponding changes in the glenohumeral joint.
- Weakness of right rotator cuff isolated function based on clinical exam findings.
- Fatty infiltration grade 2 or more for involved muscle bellies based on MRI findings.
Who cannot join
- Unable to achieve 30º of external rotation and 140º of elevation in the scapular plane, where the limitations are not due to cuff tear associated pain.
- Diagnosis of osteoarthritis of the shoulder on their right side.
- History of musculoskeletal injury or disorder affecting any part of the right arm except the rotator cuff of the shoulder.
- History of musculoskeletal injury or disorder affecting any part of the left arm.
- Any musculoskeletal injury or disorder which prevents the subject standing unassisted for an extended period.
- Parkinson's disease.
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- History of cerebral vascular accident.
- Pregnant.
- Current Incarceration.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MORE Foundation
Phoenix, Arizona, 85023
John D McCamley, PhD, 623-241-8721, john.mccamley@more-foundation.org
Debra Sietsema, PhD, 623.455.7109, debra.sietsema@more-foundation.org
About this study
A comprehensive understanding of healthy shoulder motion is a valuable contribution to the academic literature and provides a basis of comparison for various shoulder pathologies and treatments. However, the medical community is primarily interested in how pathology affects shoulder function and the underlying musculoskeletal reasons for impaired function associated with specific pathologies. Rotator cuff tears (RCT) provide an excellent model to study shoulder biomechanics because RCTs can cause significant functional impairment and can be quantified in size and location using standard clinical imaging techniques.
Upon completion of this study a comprehensive database of three-dimensional joint angles and EMG patterns of the structures of the shoulder joint complex of dominant and non-dominant during common activities of daily living will be available for healthy subjects and those of subjects whose dominant limbs are impaired by rotator cuff tears. These data will show normal muscle activations and movement patterns required to complete activities of daily living and compare them to the movement, and muscle activation patterns of persons who exhibit muscular and movement dysfunction due to rotator cuff tears.
Read the detailed description
Rotator cuff tears occur in approximately 20% of patients older than 65 years and increase with age. These non-traumatic RCTs are generally caused by normal age-related degeneration. Surgical treatment is effective, however recurrence of injury is common especially when the original tear was caused by age related degeneration. Non-surgical treatment options are designed to decrease pain and improve performance of activities of daily living and may be an effective alternative to surgery. If non-surgical treatment options are unsuccessful, surgical treatment may be considered. When rotator cuff tears are treated surgically, postoperative rehabilitation is an important factor in determining outcome success, however there is uncertainty regarding the best protocols for post-surgery rehabilitation. Evidence suggests that a more complete understanding of motion and muscle activation is necessary to design effective and reliable rehabilitation programs for rotator cuff injuries.
These data will enable medical professionals to better answer a range of clinical questions. They will provide health care professionals and researchers with a knowledge of relative muscle contributions to specific joint motions required to perform activities of daily living. This information is well suited to refine input variables for computer models and robotic testing platforms which can improve virtual and cadaver testing of shoulder impairment and repair models. Understanding the limitations to movement caused by RCT, and the resulting muscle activation patterns, will inform better surgical indications and enable therapists to better design rehabilitation protocols to enhance recovery from rotator cuff tears with or without surgery, as well as develop programs to limit future tears. Knowledge of muscle activation patterns during activities of daily living will also allow pre-habilitation protocols to be tailored for a subsequent surgical procedure such as reverse shoulder arthroplasty. These data will also assist in the design of shoulder prostheses whose biomechanical characteristics will compensate for deficiencies present in a shoulder joint impaired by rotator cuff injury. The knowledge gained from this study will provide a basis for future studies investigating traumatic shoulder injuries and the design of effective rehabilitation protocols for such injuries.
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator cuff tear, Shoulder motion, Shoulder muscle activation
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy validation subjects | Healthy subjects who meet the inclusion criteria and participate in data collection for the purpose of developing and validating the biomechanical models used to track scapular motion | |
| Healthy comparison subjects | Healthy subjects who meet the inclusion criteria and participate in data collection for comparison of shoulder motion and muscle activation patterns with RCT subjects | |
| RCT subjects | Subjects who have sustained a major rotator cuff tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Measure range of motion in abduction, forward flexion, external rotation in neutral position and external rotation at 90 degrees abductions with corresponding rotator cuff muscle activation patterns
Measured: At enrollment
Activities of Daily Living
Measure glenohumeral joint angles and rotator cuff muscle activation patterns during the performance of prescribed activities of daily living
Measured: At enrollment
Secondary outcomes (1)
Patient reported outcome
Completion of QuickDASH questionnaire
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start28 Jan 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- More Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes Products, Inc.
- Responsible party
- Sponsor
- Investigators
- Marc D Jacofsky, PhD, Study director, More Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571268
- Sponsor's protocol ID
- 4030
- Status last verified
- Oct 2021
- First submitted
- 12 Sep 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motions of the Bones and Activation of the Muscles of the Shoulder Girdle During Basic and Common Arm Movement
- ClinicalTrials.gov ID
- NCT04571268
- Acronym / sponsor ID
- 4030
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator cuff tear, Shoulder motion, Shoulder muscle activation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- More FoundationUniversity, hospital or other
- Collaborators
- DePuy Synthes Products, Inc.
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 1 Oct 2020 (actual)
- 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.
A comprehensive understanding of healthy shoulder motion is a valuable contribution to the academic literature and provides a basis of comparison for various shoulder pathologies and treatments. However, the medical community is primarily interested in how pathology affects shoulder function and the underlying musculoskeletal reasons for impaired function associated with specific pathologies. Rotator cuff tears (RCT) provide an excellent model to study shoulder biomechanics because RCTs can cause significant functional impairment and can be quantified in size and location using standard clinical imaging techniques.
Upon completion of this study a comprehensive database of three-dimensional joint angles and EMG patterns of the structures of the shoulder joint complex of dominant and non-dominant during common activities of daily living will be available for healthy subjects and those of subjects whose dominant limbs are impaired by rotator cuff tears. These data will show normal muscle activations and movement patterns required to complete activities of daily living and compare them to the movement, and muscle activation patterns of persons who exhibit muscular and movement dysfunction due to rotator cuff tears.
Detailed description
Rotator cuff tears occur in approximately 20% of patients older than 65 years and increase with age. These non-traumatic RCTs are generally caused by normal age-related degeneration. Surgical treatment is effective, however recurrence of injury is common especially when the original tear was caused by age related degeneration. Non-surgical treatment options are designed to decrease pain and improve performance of activities of daily living and may be an effective alternative to surgery. If non-surgical treatment options are unsuccessful, surgical treatment may be considered. When rotator cuff tears are treated surgically, postoperative rehabilitation is an important factor in determining outcome success, however there is uncertainty regarding the best protocols for post-surgery rehabilitation. Evidence suggests that a more complete understanding of motion and muscle activation is necessary to design effective and reliable rehabilitation programs for rotator cuff injuries.
These data will enable medical professionals to better answer a range of clinical questions. They will provide health care professionals and researchers with a knowledge of relative muscle contributions to specific joint motions required to perform activities of daily living. This information is well suited to refine input variables for computer models and robotic testing platforms which can improve virtual and cadaver testing of shoulder impairment and repair models. Understanding the limitations to movement caused by RCT, and the resulting muscle activation patterns, will inform better surgical indications and enable therapists to better design rehabilitation protocols to enhance recovery from rotator cuff tears with or without surgery, as well as develop programs to limit future tears. Knowledge of muscle activation patterns during activities of daily living will also allow pre-habilitation protocols to be tailored for a subsequent surgical procedure such as reverse shoulder arthroplasty. These data will also assist in the design of shoulder prostheses whose biomechanical characteristics will compensate for deficiencies present in a shoulder joint impaired by rotator cuff injury. The knowledge gained from this study will provide a basis for future studies investigating traumatic shoulder injuries and the design of effective rehabilitation protocols for such injuries.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy validation subjects | – | –Healthy subjects who meet the inclusion criteria and participate in data collection for the purpose of developing and validating the biomechanical models used to track scapular motion |
| Healthy comparison subjects | – | –Healthy subjects who meet the inclusion criteria and participate in data collection for comparison of shoulder motion and muscle activation patterns with RCT subjects |
| RCT subjects | – | –Subjects who have sustained a major rotator cuff tear |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between 50 and 70 years old, inclusive, who present with chronic right shoulder pain with a documented right rotator cuff tear will be screened for eligibility and participation. Rotator cuff tear subjects will be recruited under consultation with physicians from their patient populations. Patient charts will be assessed by study investigators to ensure they meet inclusion/exclusion criteria prior to consent. Healthy subjects will be recruited by flyer and word of mouth from the surrounding general population. Healthy subjects will be of similar demographics to the rotator cuff tear subjects.
Key inclusion criteria (9 listed)
- All subjects
- Right hand dominant
- English speaking
- Subjects who have read and signed IRB approved informed consent for the study.
- Chronic right-side side shoulder pain with documented rotator cuff tear involving 2 or more tendons, and greater than 5cm as diagnosed by MRI
Key exclusion criteria (9 listed)
- Unable to achieve 30º of external rotation and 140º of elevation in the scapular plane, where the limitations are not due to cuff tear associated pain.
- Diagnosis of osteoarthritis of the shoulder on their right side.
- History of musculoskeletal injury or disorder affecting any part of the right arm except the rotator cuff of the shoulder.
- History of musculoskeletal injury or disorder affecting any part of the left arm.
- Any musculoskeletal injury or disorder which prevents the subject standing unassisted for an extended period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Range of motion
Time frame: At enrollment
Measure range of motion in abduction, forward flexion, external rotation in neutral position and external rotation at 90 degrees abductions with corresponding rotator cuff muscle activation patterns
Activities of Daily Living
Time frame: At enrollment
Measure glenohumeral joint angles and rotator cuff muscle activation patterns during the performance of prescribed activities of daily living
1 secondary outcome
Patient reported outcome
Time frame: At enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
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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.
Marc D Jacofsky, PhD study director
More Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears, run by More Foundation 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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John D McCamley, PhD (634.241.8721, john.mccamley@more-foundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: At enrollment). The study lists 2 primary outcomes in all. 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 6 Oct 2021.