Shoulder PainNCT01608997
Postoperative Multiparameter Outcomes During the Six Months After Rotator Cuff Repair
An observational study of Shoulder Pain and Quality of Life, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Rotator cuff tears are common amongst 50-60 year olds with no connection to their physical activity. When symptomatic, the injury affects all aspects of general health, quality of life and function. Surgical intervention is recommended only if conservative treatment fails. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Shoulder Pain, Quality of Life, Satisfaction
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to Aug 2013
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Candidates for rotator cuff repair due to shoulder pain and tears
Who may be able to join
- Patients with chronic tears in supraspinatus and infraspinatus tendon
- Symptoms of up to 12 months
- No relief from conservative treatment
- Complete or almost complete tears of up to 3cm
- Hebrew speakers
Who cannot join
- Previous trauma
- Shoulder Infection
- Recurrent dislocation
- Avascular necrosis
- Frozen shoulder
- Additional tears
- Otherwise healthy
Trial locations and contacts
1 site in 1 country.
About this study
Rotator cuff tears are common amongst 50-60 year olds with no connection to their physical activity. When symptomatic, the injury affects all aspects of general health, quality of life and function. Surgical intervention is recommended only if conservative treatment fails. The purpose of the surgical intervention is to reduce pain, and improve function while improving range of motion and muscle strength around the shoulder. The purpose of the current study is to measure physical, functional, expectation, satisfaction and quality of life outcomes after rotator cuff repair surgery. Another purpose is to learn the reproducibility components of the above outcomes.
- Conditions
- Shoulder Pain, Quality of Life, Satisfaction
- Medical subject headings
- Shoulder Pain, Personal Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Function
Outcome measurements will be collected through the use of the Quick Disability of Arm Shoulder and Hand Score (QuickDASH) questionnaire.
Measured: Six Months
Quality of Life
Outcome measurements will be collected through the use of the Twelve Item Health Status Survey (SF12)
Measured: Six Months
Secondary outcomes (3)
Self-Rated Improvement, Expectations and Satisfaction
Outcome measurements will be collected through the use of the Patient Global Rating of Change Questionnaire
Measured: Six Months
Range of Motion of the Shoulder
Outcome will be measured through the use of a digital inclinometer
Measured: Six Months
Isometric strength around the shoulder
Outcome will be measured by a hand-held dynamometer (HHD)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608997
- Sponsor's protocol ID
- 0071-11-HYMC
- Status last verified
- May 2012
- First submitted
- 29 May 2012
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Multiparameter Outcomes During the Six Months After Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT01608997
- Acronym / sponsor ID
- 0071-11-HYMC
- Conditions
- Shoulder Pain, Quality of Life, Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jun 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 31 May 2012 (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.
Rotator cuff tears are common amongst 50-60 year olds with no connection to their physical activity. When symptomatic, the injury affects all aspects of general health, quality of life and function. Surgical intervention is recommended only if conservative treatment fails. The purpose of the surgical intervention is to reduce pain, and improve function while improving range of motion and muscle strength around the shoulder. The purpose of the current study is to measure physical, functional, expectation, satisfaction and quality of life outcomes after rotator cuff repair surgery. Another purpose is to learn the reproducibility components of the above outcomes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidates for rotator cuff repair due to shoulder pain and tears
Key inclusion criteria (5 listed)
- Patients with chronic tears in supraspinatus and infraspinatus tendon
- Symptoms of up to 12 months
- No relief from conservative treatment
- Complete or almost complete tears of up to 3cm
- Hebrew speakers
Key exclusion criteria (7 listed)
- Previous trauma
- Shoulder Infection
- Recurrent dislocation
- Avascular necrosis
- Frozen shoulder
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
Shoulder Function
Time frame: Six Months
Outcome measurements will be collected through the use of the Quick Disability of Arm Shoulder and Hand Score (QuickDASH) questionnaire.
Quality of Life
Time frame: Six Months
Outcome measurements will be collected through the use of the Twelve Item Health Status Survey (SF12)
3 secondary outcomes
Self-Rated Improvement, Expectations and Satisfaction
Time frame: Six Months
Range of Motion of the Shoulder
Time frame: Six Months
Isometric strength around the shoulder
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
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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.
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 Shoulder Pain and Quality of Life, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 5 inclusion and 7 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 31 May 2012. 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 Israel. 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 Ayelet Yahav Galkin, BPT (972-542644500, yahavgalkin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Function (time frame: Six Months). 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 31 May 2012.