Partial Tear of Rotator CuffEOCPISNCT02440477
The Effect of Changing Posture in Sitting on Selected Clinical Shoulder Tests
An observational study of Partial Tear of Rotator Cuff, run by Meir Medical Center at 2 sites in Israel.
Trial summary
Background: Shoulder pain is the third most common musculoskeletal problem accounting almost 21% of all musculoskeletal complaints. Symptomatic Rotator cuff degenerative tears (RCDT) are mostly common above the age of 40. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partial Tear of Rotator Cuff
- What is being tested?
- clinical shoulder tests
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Jul 2015to 1 Apr 2017
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged over 40 years with partial rotator cuff degenerative tears that were diagnosed by ultrasound.
Who may be able to join
- Patients aged over 40 years.
- Patients with partial rotator cuff degenerative tears that were diagnosed by ultrasound.
Who cannot join
- Recent trauma to the upper quadrant.
- Patients with spondyloarthropaties and or rheumatological diseases
- Any oncological disease.
- Any surgery or fractures in the upper quadrant.
- Systemic vascular pathology.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Bat yamon physical therapy
Bat Yam, Israel
Holon Physiotherapy
Holon, Israel
About this study
Official title: The Effect of Changing Posture in Sitting on Selected Clinical Shoulder Tests in Patients With Rotator Cuff Degenerative Tears
Background: Shoulder pain is the third most common musculoskeletal problem accounting almost 21% of all musculoskeletal complaints. Symptomatic Rotator cuff degenerative tears (RCDT) are mostly common above the age of 40. Deviations of posture in the upper quadrant such as, slouched posture and forward head position, have been linked repeatedly to rotator cuff diseases, altered scapular kinematics and changes in the acromiohumeral distance (AHD). No study yet examined the effect of changing posture in sitting on the output of shoulder clinical tests, in patients with RCDT.
Objectives: The primary objective of the study is to examine the effect of changing posture in sitting on selected clinical shoulder tests in patients with rotator cuff degenerative tears (RCDT) Study design: A single blinded controlled clinical trial Methods: A total of 100 subjects (Patients referred to physiotherapy outpatient clinics of Clalit Healthcare Services in Holon and Hertzlyia) will be included in this study and divided into 2 groups: 50 subjects with shoulder pain who are diagnosed with RCDT by ultrasound and a control group of 50 volunteering subjects without any pain in the upper quadrant. All patients will be measured for their body weight and height and their hand dominance will be notified. Following reliability trials on the first 10 subjects, all subjects will be tested for pain provocation and level of pain (VAS) in both shoulders with 3 commonly used clinical shoulder tests for the diagnosis of rotator cuff diseases (Empty can - sensitivity=94%, specificity = 46% Neer test - sensitivity = 72%, specificity = 60%, and Hawkins-Kennedy test - sensitivity = 79%, specificity = 59% ) in 3 sitting postures; normal resting posture, slouched posture, and upright posture with scapular retraction as described by Kalra et al (2010). In addition, the rotator cuff muscle strength tests during shoulder abduction, internal rotation and external rotation will be measured for the 2 shoulders using a hand-held dynamometer.
Read the detailed description
Quality assurance - "clalit" health services will provide ongoing auditing and monitoring of the study. data checks will be also examined by "clalit health services". the investigators are obliged to enter all the data into logs provided upfront by the organisation. All the data obtained will be stored in an original folder intended for inspection and all encounters with volunteers will be documented in the computerized medical file of the volunteers. Standard operating procedures will be followed by the regulations expected by "clalit" health services and the Israeli ministry of health. After the first 10 volunteers of the study a reliability and validity statistical analysis will be made to assess the sample size estimated. Missing, unavailable, "non-reported" or uninterpretable data will be excluded from the final analysis.Data will be analyzed using the Statistical Package for the Social Sciences Version 15 (SPSS Inc., Chicago, IL, USA). Results of measurements of each test will be analyzed for mean, standard deviation (SD) and range. Categorical variables will be described percentiles/median. Changes of variables in the same subject will be analyzed using a paired T test for continuous variables and Mann-Whitney test for categorical variables. In addition, the correlations between variables will be calculated using ICC. P values smaller than 0.05 (p<0.05) will be considered significant
- Conditions
- Partial Tear of Rotator Cuff
- Being tested
- clinical shoulder tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical shoulder testsOther
Three clinical shoulder tests (Neer impingement sign,Hawkins-kennedy, empty can) performed in three different sitting positions: normal resting posture, slouched posture, and upright posture with scapular retraction and shoulder. and in addition shoulder muscle strength test with handheld dynamometer
| Study group | Role | What they receive |
|---|---|---|
| partial rotator cuff tears | 50 subjects with shoulder pain who are diagnosed with partial rotator cuff degenrative tears by ultrasound. All patients will be measured for their body weight and height and their hand dominance will be notified. Following reliability trials on the first 10 subjects, all subjects will be tested for pain provocation and level of pain (VAS) in both shoulders with 3 commonly used clinical shoulder tests for the diagnosis of rotator cuff diseases Empty can ,Neer test and Hawkins-Kennedy test in 3 sitting postures; normal resting posture, slouched posture, and upright posture with scapular retraction. In addition, the rotator cuff muscle strength tests during shoulder abduction, internal rotation and external rotation will be measured for the 2 shoulders using a hand-held dynamometer. Receives: Other: clinical shoulder tests | |
| control group | 50 volunteering subjects without any pain in the upper quadrant.All patients will be measured for their body weight and height and their hand dominance will be notified. Following reliability trials on the first 10 subjects, all subjects will be tested for pain provocation and level of pain (VAS) in both shoulders with 3 commonly used clinical shoulder tests for the diagnosis of rotator cuff diseases Empty can ,Neer test and Hawkins-Kennedy test in 3 sitting postures; normal resting posture, slouched posture, and upright posture with scapular retraction. In addition, the rotator cuff muscle strength tests during shoulder abduction, internal rotation and external rotation will be measured for the 2 shoulders using a hand-held dynamometer. Receives: Other: clinical shoulder tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neer test , empty can test, Hawkins Kennedy test
Measured: one year
Secondary outcomes (1)
shoulder muscle testing
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study start1 Jul 2015
- Primary completion1 Apr 2017 (estimated)
- Study completion1 Apr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Partial Tear of Rotator CuffStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- shlomo bierkenfeld, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440477
- Sponsor's protocol ID
- ק018/2015
- Acronym
- EOCPIS
- Status last verified
- Feb 2017
- First submitted
- 7 May 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, Simmons A, Williams G. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998 Nov;57(11):649-55. doi: 10.1136/ard.57.11.649.
PubMed 9924205Kalra N, Seitz AL, Boardman ND 3rd, Michener LA. Effect of posture on acromiohumeral distance with arm elevation in subjects with and without rotator cuff disease using ultrasonography. J Orthop Sports Phys Ther. 2010 Oct;40(10):633-40. doi: 10.2519/jospt.2010.3155.
PubMed 20710092Bullock MP, Foster NE, Wright CC. Shoulder impingement: the effect of sitting posture on shoulder pain and range of motion. Man Ther. 2005 Feb;10(1):28-37. doi: 10.1016/j.math.2004.07.002.
PubMed 15681266Cutti AG, Veeger HE. Shoulder biomechanics: today's consensus and tomorrow's perspectives. Med Biol Eng Comput. 2009 May;47(5):463-6. doi: 10.1007/s11517-009-0487-3. Epub 2009 Apr 25.
PubMed 19396486Lugo R, Kung P, Ma CB. Shoulder biomechanics. Eur J Radiol. 2008 Oct;68(1):16-24. doi: 10.1016/j.ejrad.2008.02.051. Epub 2008 Jun 3.
PubMed 18511227Lewis JS. Subacromial impingement syndrome: a musculoskeletal condition or a clinical illusion? Physical Therapy Reviews.2011; 16(5): 1-12.
Kebaetse M, McClure P, Pratt NA. Thoracic position effect on shoulder range of motion, strength, and three-dimensional scapular kinematics. Arch Phys Med Rehabil. 1999 Aug;80(8):945-50. doi: 10.1016/s0003-9993(99)90088-6.
PubMed 10453773Donatelli R. Physical Therapy of the Shoulder (Clinics in Physical Therapy). 4th ed. New York, NY: Churchill-Livingstone; 2004.
Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.
PubMed 6825348Greenfield B, Catlin PA, Coats PW, Green E, McDonald JJ, North C. Posture in patients with shoulder overuse injuries and healthy individuals. J Orthop Sports Phys Ther. 1995 May;21(5):287-95. doi: 10.2519/jospt.1995.21.5.287.
PubMed 7787853Culham E, Peat M. Functional anatomy of the shoulder complex. J Orthop Sports Phys Ther. 1993 Jul;18(1):342-50. doi: 10.2519/jospt.1993.18.1.342.
PubMed 8348135Ludewig PM, Reynolds JF. The association of scapular kinematics and glenohumeral joint pathologies. J Orthop Sports Phys Ther. 2009 Feb;39(2):90-104. doi: 10.2519/jospt.2009.2808.
PubMed 19194022Lukasiewicz AC, McClure P, Michener L, Pratt N, Sennett B. Comparison of 3-dimensional scapular position and orientation between subjects with and without shoulder impingement. J Orthop Sports Phys Ther. 1999 Oct;29(10):574-83; discussion 584-6. doi: 10.2519/jospt.1999.29.10.574.
PubMed 10560066Hegedus EJ, Goode A, Campbell S, Morin A, Tamaddoni M, Moorman CT 3rd, Cook C. Physical examination tests of the shoulder: a systematic review with meta-analysis of individual tests. Br J Sports Med. 2008 Feb;42(2):80-92; discussion 92. doi: 10.1136/bjsm.2007.038406. Epub 2007 Aug 24.
PubMed 17720798Schellingerhout JM, Verhagen AP, Thomas S, Koes BW. Lack of uniformity in diagnostic labeling of shoulder pain: time for a different approach. Man Ther. 2008 Dec;13(6):478-83. doi: 10.1016/j.math.2008.04.005. Epub 2008 Jun 13.
PubMed 18555732
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Changing Posture in Sitting on Selected Clinical Shoulder Tests in Patients With Rotator Cuff Degenerative Tears
- ClinicalTrials.gov ID
- NCT02440477
- Acronym / sponsor ID
- EOCPIS / ק018/2015
- Conditions
- Partial Tear of Rotator Cuff
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2015
- Primary completion
- 1 Apr 2017 (estimated)
- Study completion
- 1 Apr 2017 (estimated)
- First posted
- 12 May 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.
Background: Shoulder pain is the third most common musculoskeletal problem accounting almost 21% of all musculoskeletal complaints. Symptomatic Rotator cuff degenerative tears (RCDT) are mostly common above the age of 40. Deviations of posture in the upper quadrant such as, slouched posture and forward head position, have been linked repeatedly to rotator cuff diseases, altered scapular kinematics and changes in the acromiohumeral distance (AHD). No study yet examined the effect of changing posture in sitting on the output of shoulder clinical tests, in patients with RCDT.
Objectives: The primary objective of the study is to examine the effect of changing posture in sitting on selected clinical shoulder tests in patients with rotator cuff degenerative tears (RCDT) Study design: A single blinded controlled clinical trial Methods: A total of 100 subjects (Patients referred to physiotherapy outpatient clinics of Clalit Healthcare Services in Holon and Hertzlyia) will be included in this study and divided into 2 groups: 50 subjects with shoulder pain who are diagnosed with RCDT by ultrasound and a control group of 50 volunteering subjects without any pain in the upper quadrant. All patients will be measured for their body weight and height and their hand dominance will be notified. Following reliability trials on the first 10 subjects, all subjects will be tested for pain provocation and level of pain (VAS) in both shoulders with 3 commonly used clinical shoulder tests for the diagnosis of rotator cuff diseases (Empty can - sensitivity=94%, specificity = 46% Neer test - sensitivity = 72%, specificity = 60%, and Hawkins-Kennedy test - sensitivity = 79%, specificity = 59% ) in 3 sitting postures; normal resting posture, slouched posture, and upright posture with scapular retraction as described by Kalra et al (2010). In addition, the rotator cuff muscle strength tests during shoulder abduction, internal rotation and external rotation will be measured for the 2 shoulders using a hand-held dynamometer.
Detailed description
Quality assurance - "clalit" health services will provide ongoing auditing and monitoring of the study. data checks will be also examined by "clalit health services". the investigators are obliged to enter all the data into logs provided upfront by the organisation. All the data obtained will be stored in an original folder intended for inspection and all encounters with volunteers will be documented in the computerized medical file of the volunteers. Standard operating procedures will be followed by the regulations expected by "clalit" health services and the Israeli ministry of health. After the first 10 volunteers of the study a reliability and validity statistical analysis will be made to assess the sample size estimated. Missing, unavailable, "non-reported" or uninterpretable data will be excluded from the final analysis.Data will be analyzed using the Statistical Package for the Social Sciences Version 15 (SPSS Inc., Chicago, IL, USA). Results of measurements of each test will be analyzed for mean, standard deviation (SD) and range. Categorical variables will be described percentiles/median. Changes of variables in the same subject will be analyzed using a paired T test for continuous variables and Mann-Whitney test for categorical variables. In addition, the correlations between variables will be calculated using ICC. P values smaller than 0.05 (p<0.05) will be considered significant
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| partial rotator cuff tears | – | Other: clinical shoulder tests50 subjects with shoulder pain who are diagnosed with partial rotator cuff degenrative tears by ultrasound. All patients will be measured for their body weight and height and their hand dominance will be notified. Following reliability trials on the first 10 subjects, all subjects will be tested for pain provocation and level of pain (VAS) in both shoulders with 3 commonly used clinical shoulder tests for the diagnosis of rotator cuff diseases Empty can ,Neer test and Hawkins-Kennedy test in 3 sitting postures; normal resting posture, slouched posture, and upright posture with scapular retraction. In addition, the rotator cuff muscle strength tests during shoulder abduction, internal rotation and external rotation will be measured for the 2 shoulders using a hand-held dynamometer. |
| control group | – | Other: clinical shoulder tests50 volunteering subjects without any pain in the upper quadrant.All patients will be measured for their body weight and height and their hand dominance will be notified. Following reliability trials on the first 10 subjects, all subjects will be tested for pain provocation and level of pain (VAS) in both shoulders with 3 commonly used clinical shoulder tests for the diagnosis of rotator cuff diseases Empty can ,Neer test and Hawkins-Kennedy test in 3 sitting postures; normal resting posture, slouched posture, and upright posture with scapular retraction. In addition, the rotator cuff muscle strength tests during shoulder abduction, internal rotation and external rotation will be measured for the 2 shoulders using a hand-held dynamometer. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged over 40 years with partial rotator cuff degenerative tears that were diagnosed by ultrasound.
Key inclusion criteria (2 listed)
- Patients aged over 40 years.
- Patients with partial rotator cuff degenerative tears that were diagnosed by ultrasound.
Key exclusion criteria (5 listed)
- Recent trauma to the upper quadrant.
- Patients with spondyloarthropaties and or rheumatological diseases
- Any oncological disease.
- Any surgery or fractures in the upper quadrant.
- Systemic vascular pathology.
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 |
|---|---|---|
| clinical shoulder testsThree clinical shoulder tests (Neer impingement sign,Hawkins-kennedy, empty can) performed in three different sitting positions: normal resting posture, slouched posture, and upright posture with scapular retraction and shoulder. and in addition shoulder muscle strength test with handheld dynamometer | Other | control group, partial rotator cuff tears |
Primary outcome
Neer test , empty can test, Hawkins Kennedy test
Time frame: one year
1 secondary outcome
shoulder muscle testing
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Background: PubMed 9924205Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, Simmons A, Williams G. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998 Nov;57(11):649-55. doi: 10.1136/ard.57.11.649.
- Background: PubMed 20710092Kalra N, Seitz AL, Boardman ND 3rd, Michener LA. Effect of posture on acromiohumeral distance with arm elevation in subjects with and without rotator cuff disease using ultrasonography. J Orthop Sports Phys Ther. 2010 Oct;40(10):633-40. doi: 10.2519/jospt.2010.3155.
- Background: PubMed 15681266Bullock MP, Foster NE, Wright CC. Shoulder impingement: the effect of sitting posture on shoulder pain and range of motion. Man Ther. 2005 Feb;10(1):28-37. doi: 10.1016/j.math.2004.07.002.
- Background: PubMed 19396486Cutti AG, Veeger HE. Shoulder biomechanics: today's consensus and tomorrow's perspectives. Med Biol Eng Comput. 2009 May;47(5):463-6. doi: 10.1007/s11517-009-0487-3. Epub 2009 Apr 25.
- Background: PubMed 18511227Lugo R, Kung P, Ma CB. Shoulder biomechanics. Eur J Radiol. 2008 Oct;68(1):16-24. doi: 10.1016/j.ejrad.2008.02.051. Epub 2008 Jun 3.
- BackgroundLewis JS. Subacromial impingement syndrome: a musculoskeletal condition or a clinical illusion? Physical Therapy Reviews.2011; 16(5): 1-12.
- Background: PubMed 10453773Kebaetse M, McClure P, Pratt NA. Thoracic position effect on shoulder range of motion, strength, and three-dimensional scapular kinematics. Arch Phys Med Rehabil. 1999 Aug;80(8):945-50. doi: 10.1016/s0003-9993(99)90088-6.
- BackgroundDonatelli R. Physical Therapy of the Shoulder (Clinics in Physical Therapy). 4th ed. New York, NY: Churchill-Livingstone; 2004.
- Background: PubMed 6825348Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.
- Background: PubMed 7787853Greenfield B, Catlin PA, Coats PW, Green E, McDonald JJ, North C. Posture in patients with shoulder overuse injuries and healthy individuals. J Orthop Sports Phys Ther. 1995 May;21(5):287-95. doi: 10.2519/jospt.1995.21.5.287.
- Background: PubMed 8348135Culham E, Peat M. Functional anatomy of the shoulder complex. J Orthop Sports Phys Ther. 1993 Jul;18(1):342-50. doi: 10.2519/jospt.1993.18.1.342.
- Background: PubMed 19194022Ludewig PM, Reynolds JF. The association of scapular kinematics and glenohumeral joint pathologies. J Orthop Sports Phys Ther. 2009 Feb;39(2):90-104. doi: 10.2519/jospt.2009.2808.
- Individual participant dataSharing planned: Yes
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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.
shlomo bierkenfeld, MD principal investigator
Clalit Health Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Partial Tear of Rotator Cuff, run by Meir Medical Center at 2 sites 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 2 inclusion and 5 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Neer test , empty can test, Hawkins Kennedy test (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440477, which also lists 29 linked publications.
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 3 Mar 2017.