Rotator Cuff DiseaseNCT00845715
Early Range of Motion Following Arthroscopic Rotator Cuff Repair
A study testing Early motion and Standard motion in people with Rotator Cuff Disease, run by UConn Health at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether there is a difference in the quality of life, ability to return to functioning (back to everyday life), the amount of experienced pain in patients who immediately move their shoulder versus patient who delay moving their shoulder after arthroscopic rotator cuff… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Disease
- What is being tested?
- Early motion and Standard motion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Apr 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are between 18 years and 70 years of age
- full thickness rotator cuff tear on ultrasound and MRI
- failed conservative management
Who cannot join
- concomitant pathology including massive rotator cuff tears that extend into the subscapularis or the teres minor and all co-existing labral pathology
- history of neuromuscular or degenerative disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: The Effect of Early Range of Motion on Clinical Outcomes, Patient Satisfaction, and Cuff Integrity Following Arthroscopic Rotator Cuff Repair. A Prospective Randomized Study.
The purpose of this study is to investigate whether there is a difference in the quality of life, ability to return to functioning (back to everyday life), the amount of experienced pain in patients who immediately move their shoulder versus patient who delay moving their shoulder after arthroscopic rotator cuff repair. We are also interested in whether there is a difference in the healing rates between these two groups.
- Conditions
- Rotator Cuff Disease
- Being tested
- Early motion, Standard motion
- Keywords
- rotator cuff, rehabilitation, range of motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early motionOther
Early referral to physical therapy for range of motion (2 days post)
Standard motionOther
Standard referral to physical therapy for range of motion (4 weeks post)
| Study group | Role | What they receive |
|---|---|---|
| Early motion | Other | Not described Receives: Other: Early motion |
| Standard motion | Other | Not described Receives: Other: Standard motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Rotator Cuff Index (WORC)
Measured: 6 month post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startJul 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Donaghue Medical Research Foundation
- Responsible party
- Principal investigator, Augustus Mazzocca, UConn Health
- Investigators
- Augustus D Mazzocca, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845715
- Sponsor's protocol ID
- 08-311-3
- Other IDs
- DF08-13
- Status last verified
- Apr 2017
- First submitted
- 13 Feb 2009
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Range of Motion on Clinical Outcomes, Patient Satisfaction, and Cuff Integrity Following Arthroscopic Rotator Cuff Repair. A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT00845715
- Acronym / sponsor ID
- 08-311-3
- Conditions
- Rotator Cuff Disease
- Keywords
- rotator cuff, rehabilitation, range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Donaghue Medical Research Foundation
- Study start
- Jul 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Feb 2009 (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 investigate whether there is a difference in the quality of life, ability to return to functioning (back to everyday life), the amount of experienced pain in patients who immediately move their shoulder versus patient who delay moving their shoulder after arthroscopic rotator cuff repair. We are also interested in whether there is a difference in the healing rates between these two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early motion | Other | Other: Early motion |
| Standard motion | Other | Other: Standard motion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who are between 18 years and 70 years of age
- full thickness rotator cuff tear on ultrasound and MRI
- failed conservative management
Key exclusion criteria (2 listed)
- concomitant pathology including massive rotator cuff tears that extend into the subscapularis or the teres minor and all co-existing labral pathology
- history of neuromuscular or degenerative disease
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 |
|---|---|---|
| Early motionEarly referral to physical therapy for range of motion (2 days post) | Other | Early motion |
| Standard motionStandard referral to physical therapy for range of motion (4 weeks post) | Other | Standard motion |
Primary outcome
Western Ontario Rotator Cuff Index (WORC)
Time frame: 6 month post surgery
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 25 Apr 2017.
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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.
Augustus D Mazzocca principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early motion and Standard motion in people with Rotator Cuff Disease, run by UConn Health 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 3 inclusion and 2 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 25 Apr 2017. 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?
Western Ontario Rotator Cuff Index (WORC) (time frame: 6 month post surgery). 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 25 Apr 2017.