Shoulder PainEccentricNCT02092272
Eccentric Exercises for Shoulder Pain
A study testing instructional exercise video source in people with Shoulder Pain, run by Mike O'Callaghan Military Hospital at 1 site in United States.
Trial summary
Patients will be randomly assigned to one of two groups using a random number generator. Group 1 will be provided with in-office instruction of standard of care eccentric exercises for rotator cuff tendinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- instructional exercise video source
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Feb 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DoD beneficiary patient 18 years or older
- Diagnosis of chronic (>30 days) shoulder pain of any etiology (traumatic vs over-use injury)
Who cannot join
- Patients < 18 years of age
- Patients with acute injury (fracture or injury within 30 days)
- Patients unable to accomplish eccentric exercise regimen without assistance
- Patients unable to view DVD
- Pregnant women
- Patients unable to read and/or understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Federal Hospital
Nellis Air Force Base, Nevada, 89191
About this study
Official title: Does Providing Instructional Exercise Videos Increase Patient Adherence Compared to In-office Instruction by Physician When Using Eccentric Exercises to Treat Shoulder Pain in Adults?
Patients will be randomly assigned to one of two groups using a random number generator. Group 1 will be provided with in-office instruction of standard of care eccentric exercises for rotator cuff tendinopathy. Group 2 will be provided with in-office instruction as well as a instructional exercise video source (DVD) to take home as a reminder on how to perform two specific standard of care eccentric exercises for rotator cuff tendinopathy. Each group will be given a card to track adherence to the standard of care eccentric exercise routine as measured only by the days that they accomplish their exercises. Study exercise diary will be collected after 12 weeks of treatment. Eccentric exercises are taught as part of standard of care for rotator cuff tendinopathy.
Read the detailed description
DoD beneficiaries age 18 or older will be recruited from the clinics at the Mike O'Callaghan Federal Medical Center (MOFMC). Subjects meeting the inclusion/exclusion criteria will be offered an opportunity to participate:
Screening Visit:
- Obtain signed Informed Consent Document and HIPAA Authorization.
- Verify inclusion/exclusion criteria
Visit 1 (may occur same day as Screening Visit):
- Subjects will be randomly assigned to one of two groups by the Research Coordinator using a random number generator, thus the Investigators will be blinded to the group assignments:
- Group 1: in-office instruction of the standard of care eccentric exercise regimen for rotator cuff tendinopathy.
- Group 2: in-office instruction of the standard of care eccentric exercise regimen for rotator cuff tendinopathy and an instructional exercise video source (DVD).
- Subjects will be given a study exercise diary to track adherence to the standard of care eccentric exercise routine.
Visit 2 (12 weeks post Visit 1):
- Study exercise diary will be collected to assess adherence. If the subject is unable to come in, they can return the study exercise diary via mail, or electronic mail.
- Conditions
- Shoulder Pain
- Being tested
- instructional exercise video source
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instructional exercise video sourceBehavioural
instructional exercise video source
| Study group | Role | What they receive |
|---|---|---|
| instructional exercise video source | Experimental | instructional exercise video source Receives: Behavioral: instructional exercise video source |
| Standard Therapy | No intervention | Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient adherence to standard of care eccentric exercise regimens
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: the PI left our facility and the new staff prefer alternate excersises
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Connor McKeown, MD, Principal investigator, Mike O'Callaghan Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092272
- Sponsor's protocol ID
- FWH20140038H
- Acronym
- Eccentric
- Status last verified
- Feb 2015
- First submitted
- 18 Mar 2014
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Providing Instructional Exercise Videos Increase Patient Adherence Compared to In-office Instruction by Physician When Using Eccentric Exercises to Treat Shoulder Pain in Adults?
- ClinicalTrials.gov ID
- NCT02092272
- Acronym / sponsor ID
- Eccentric / FWH20140038H
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the PI left our facility and the new staff prefer alternate excersises
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 Mar 2014 (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.
Patients will be randomly assigned to one of two groups using a random number generator. Group 1 will be provided with in-office instruction of standard of care eccentric exercises for rotator cuff tendinopathy. Group 2 will be provided with in-office instruction as well as a instructional exercise video source (DVD) to take home as a reminder on how to perform two specific standard of care eccentric exercises for rotator cuff tendinopathy. Each group will be given a card to track adherence to the standard of care eccentric exercise routine as measured only by the days that they accomplish their exercises. Study exercise diary will be collected after 12 weeks of treatment. Eccentric exercises are taught as part of standard of care for rotator cuff tendinopathy.
Detailed description
DoD beneficiaries age 18 or older will be recruited from the clinics at the Mike O'Callaghan Federal Medical Center (MOFMC). Subjects meeting the inclusion/exclusion criteria will be offered an opportunity to participate:
Screening Visit:
- Obtain signed Informed Consent Document and HIPAA Authorization.
- Verify inclusion/exclusion criteria
Visit 1 (may occur same day as Screening Visit):
- Subjects will be randomly assigned to one of two groups by the Research Coordinator using a random number generator, thus the Investigators will be blinded to the group assignments:
- Group 1: in-office instruction of the standard of care eccentric exercise regimen for rotator cuff tendinopathy.
- Group 2: in-office instruction of the standard of care eccentric exercise regimen for rotator cuff tendinopathy and an instructional exercise video source (DVD).
- Subjects will be given a study exercise diary to track adherence to the standard of care eccentric exercise routine.
Visit 2 (12 weeks post Visit 1):
- Study exercise diary will be collected to assess adherence. If the subject is unable to come in, they can return the study exercise diary via mail, or electronic mail.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| instructional exercise video source | Experimental | Behavioral: instructional exercise video sourceinstructional exercise video source |
| Standard Therapy | No intervention | –Standard Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DoD beneficiary patient 18 years or older
- Diagnosis of chronic (>30 days) shoulder pain of any etiology (traumatic vs over-use injury)
Key exclusion criteria (6 listed)
- Patients < 18 years of age
- Patients with acute injury (fracture or injury within 30 days)
- Patients unable to accomplish eccentric exercise regimen without assistance
- Patients unable to view DVD
- Pregnant women
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 |
|---|---|---|
| instructional exercise video sourceinstructional exercise video source | Behavioural | instructional exercise video source |
Primary outcome
patient adherence to standard of care eccentric exercise regimens
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: the PI left our facility and the new staff prefer alternate excersises). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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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.
Connor McKeown, MD principal investigator
Mike O'Callaghan Military Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing instructional exercise video source in people with Shoulder Pain, run by Mike O'Callaghan Military Hospital 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Feb 2015. 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 was stopped early (reason given: the PI left our facility and the new staff prefer alternate excersises). Results are not available in the source record.
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?
patient adherence to standard of care eccentric exercise regimens (time frame: 12 weeks). 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 10 Feb 2015.