HemiplegiaNCT00998868
Rotator Cuff Tears in Hemiplegic Shoulder
An observational study of Hemiplegia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of the study is to evaluate the prevalence of rotator cuff tears in the shoulders of hemiplegic patients of different severity. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hemiplegia
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2008to Aug 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: university hospital, department of rehabilitation medicine admitted patients due to hemiplegia
Who may be able to join
- hemiplegia; unilateral weakness of sudden onset
- secondary to strokes or other brain lesions
- compatible with brain lesions confirmed by imaging studies
Who cannot join
- bilateral weakness
- any history of intensive trauma of the shoulder, reported
- preexisting musculoskeletal disorder of the shoulder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Evaluate the Prevalence of Rotator Cuff Tears in Hemiplegic Shoulders
The purpose of the study is to evaluate the prevalence of rotator cuff tears in the shoulders of hemiplegic patients of different severity.
Read the detailed description
Rotator cuff tears are often suspected to contribute hemiplegic shoulder pain. However, it is controversial whether their incidence increases in hemiplegia. Based on the postulate that muscle weakness in hemiplegia predisposes rotator cuff injury due to biomechanical failure, this study aims to investigate whether the rotator cuff tears are associated with the muscle strength of the shoulder by observing hemiplegic shoulders of varying degree of paresis.
- Conditions
- Hemiplegia
- Keywords
- Rotator Cuff, Tendinopathy, ultrasonography
- Medical subject headings
- Hemiplegia, Tendinopathy
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 |
|---|---|---|
| hemiplegia | patients with hemiplegia, without other musculoskeletal disorders of the shoulder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography
All patients underwent ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.
Measured: within one month after enrollment
Secondary outcomes (3)
Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography
All patients were performed ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.
Measured: within one month after enrollment
Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination
The glenohumeral joint subluxation was examined by palpating the subacromial regions of the both sides and comparing the affected side with the unaffected side while patients are seated and relaxed. If the palpated space between the acromion and the humeral head was wider on the affected side by one half finger breath or more, it was judged to be subluxation.
Measured: within one month after enrollment
Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System
Muscle strength was measured for forward flexion and abduction of the shoulder per Medical Research Council (MRC) scale in each participants. Their mean +/- SD were calculated in each group.
MRC scale:
Grade 5: Normal and can move against full resistance. Grade 4: Reduced but can move against resistance. Grade 3: Can move only against gravity Grade 2: Can move without gravity Grade 1: Only a trace of movement Grade 0: No movement.
Measured: within one month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startJan 2008
- Primary completionApr 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Gun Chung, Seoul National University Hospital
- Investigators
- Tai Ryoon Han, MD, PhD, Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998868
- Sponsor's protocol ID
- SNUH-RM-TRHan-RCTHS-01
- Status last verified
- Sep 2011
- First submitted
- 20 Oct 2009
- Last updated
- 30 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Reilly P, Macleod I, Macfarlane R, Windley J, Emery RJ. Dead men and radiologists don't lie: a review of cadaveric and radiological studies of rotator cuff tear prevalence. Ann R Coll Surg Engl. 2006 Mar;88(2):116-21. doi: 10.1308/003588406X94968.
PubMed 16551396Sano H, Ishii H, Trudel G, Uhthoff HK. Histologic evidence of degeneration at the insertion of 3 rotator cuff tendons: a comparative study with human cadaveric shoulders. J Shoulder Elbow Surg. 1999 Nov-Dec;8(6):574-9. doi: 10.1016/s1058-2746(99)90092-7.
PubMed 10633891Yu D. Shoulder pain in hemiplegia. Phys Med Rehabil Clin N Am. 2004 Aug;15(3):vi-vii, 683-97. doi: 10.1016/S1047-9651(03)00130-X.
PubMed 15219895Bender L, McKenna K. Hemiplegic shoulder pain: defining the problem and its management. Disabil Rehabil. 2001 Nov 10;23(16):698-705. doi: 10.1080/09638280110062149.
PubMed 11732559Gilmore PE, Spaulding SJ, Vandervoort AA. Hemiplegic shoulder pain: implications for occupational therapy treatment. Can J Occup Ther. 2004 Feb;71(1):36-46. doi: 10.1177/000841740407100108.
PubMed 15015899Van Ouwenaller C, Laplace PM, Chantraine A. Painful shoulder in hemiplegia. Arch Phys Med Rehabil. 1986 Jan;67(1):23-6.
PubMed 3942479Joynt RL. The source of shoulder pain in hemiplegia. Arch Phys Med Rehabil. 1992 May;73(5):409-13.
PubMed 1580765Hakuno A, Sashika H, Ohkawa T, Itoh R. Arthrographic findings in hemiplegic shoulders. Arch Phys Med Rehabil. 1984 Nov;65(11):706-11.
PubMed 6497618Rizk TE, Christopher RP, Pinals RS, Salazar JE, Higgins C. Arthrographic studies in painful hemiplegic shoulders. Arch Phys Med Rehabil. 1984 May;65(5):254-6.
PubMed 6712451Lo SF, Chen SY, Lin HC, Jim YF, Meng NH, Kao MJ. Arthrographic and clinical findings in patients with hemiplegic shoulder pain. Arch Phys Med Rehabil. 2003 Dec;84(12):1786-91. doi: 10.1016/s0003-9993(03)00408-8.
PubMed 14669184Najenson T, Yacubovich E, Pikielni SS. Rotator cuff injury in shoulder joints of hemiplegic patients. Scand J Rehabil Med. 1971;3(3):131-7. No abstract available.
PubMed 5156175Nepomuceno CS, Miller JM 3rd. Shoulder arthrography in hemiplegic patients. Arch Phys Med Rehabil. 1974 Feb;55(2):49-51. No abstract available.
PubMed 4810651Wolff AB, Sethi P, Sutton KM, Covey AS, Magit DP, Medvecky M. Partial-thickness rotator cuff tears. J Am Acad Orthop Surg. 2006 Dec;14(13):715-25. doi: 10.5435/00124635-200612000-00003.
PubMed 17148619Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder. 1972. J Bone Joint Surg Am. 2005 Jun;87(6):1399. doi: 10.2106/JBJS.8706.cl.
PubMed 15930554MacGillivray JD, Fealy S, Potter HG, O'Brien SJ. Multiplanar analysis of acromion morphology. Am J Sports Med. 1998 Nov-Dec;26(6):836-40. doi: 10.1177/03635465980260061701.
PubMed 9850788
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Prevalence of Rotator Cuff Tears in Hemiplegic Shoulders
- ClinicalTrials.gov ID
- NCT00998868
- Acronym / sponsor ID
- SNUH-RM-TRHan-RCTHS-01
- Conditions
- Hemiplegia
- Keywords
- Rotator Cuff, Tendinopathy, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Posted 22 Sep 2011
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 the study is to evaluate the prevalence of rotator cuff tears in the shoulders of hemiplegic patients of different severity.
Detailed description
Rotator cuff tears are often suspected to contribute hemiplegic shoulder pain. However, it is controversial whether their incidence increases in hemiplegia. Based on the postulate that muscle weakness in hemiplegia predisposes rotator cuff injury due to biomechanical failure, this study aims to investigate whether the rotator cuff tears are associated with the muscle strength of the shoulder by observing hemiplegic shoulders of varying degree of paresis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hemiplegia | – | –patients with hemiplegia, without other musculoskeletal disorders of the shoulder |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- university hospital, department of rehabilitation medicine admitted patients due to hemiplegia
Key inclusion criteria (3 listed)
- hemiplegia; unilateral weakness of sudden onset
- secondary to strokes or other brain lesions
- compatible with brain lesions confirmed by imaging studies
Key exclusion criteria (3 listed)
- bilateral weakness
- any history of intensive trauma of the shoulder, reported
- preexisting musculoskeletal disorder of the 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
Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography
Time frame: within one month after enrollment
All patients underwent ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.
3 secondary outcomes
Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography
Time frame: within one month after enrollment
Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination
Time frame: within one month after enrollment
Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System
Time frame: within one month after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16551396Reilly P, Macleod I, Macfarlane R, Windley J, Emery RJ. Dead men and radiologists don't lie: a review of cadaveric and radiological studies of rotator cuff tear prevalence. Ann R Coll Surg Engl. 2006 Mar;88(2):116-21. doi: 10.1308/003588406X94968.
- Background: PubMed 10633891Sano H, Ishii H, Trudel G, Uhthoff HK. Histologic evidence of degeneration at the insertion of 3 rotator cuff tendons: a comparative study with human cadaveric shoulders. J Shoulder Elbow Surg. 1999 Nov-Dec;8(6):574-9. doi: 10.1016/s1058-2746(99)90092-7.
- Background: PubMed 15219895Yu D. Shoulder pain in hemiplegia. Phys Med Rehabil Clin N Am. 2004 Aug;15(3):vi-vii, 683-97. doi: 10.1016/S1047-9651(03)00130-X.
- Background: PubMed 11732559Bender L, McKenna K. Hemiplegic shoulder pain: defining the problem and its management. Disabil Rehabil. 2001 Nov 10;23(16):698-705. doi: 10.1080/09638280110062149.
- Background: PubMed 15015899Gilmore PE, Spaulding SJ, Vandervoort AA. Hemiplegic shoulder pain: implications for occupational therapy treatment. Can J Occup Ther. 2004 Feb;71(1):36-46. doi: 10.1177/000841740407100108.
- Background: PubMed 3942479Van Ouwenaller C, Laplace PM, Chantraine A. Painful shoulder in hemiplegia. Arch Phys Med Rehabil. 1986 Jan;67(1):23-6.
- Background: PubMed 1580765Joynt RL. The source of shoulder pain in hemiplegia. Arch Phys Med Rehabil. 1992 May;73(5):409-13.
- Background: PubMed 6497618Hakuno A, Sashika H, Ohkawa T, Itoh R. Arthrographic findings in hemiplegic shoulders. Arch Phys Med Rehabil. 1984 Nov;65(11):706-11.
- Background: PubMed 6712451Rizk TE, Christopher RP, Pinals RS, Salazar JE, Higgins C. Arthrographic studies in painful hemiplegic shoulders. Arch Phys Med Rehabil. 1984 May;65(5):254-6.
- Background: PubMed 14669184Lo SF, Chen SY, Lin HC, Jim YF, Meng NH, Kao MJ. Arthrographic and clinical findings in patients with hemiplegic shoulder pain. Arch Phys Med Rehabil. 2003 Dec;84(12):1786-91. doi: 10.1016/s0003-9993(03)00408-8.
- Background: PubMed 5156175Najenson T, Yacubovich E, Pikielni SS. Rotator cuff injury in shoulder joints of hemiplegic patients. Scand J Rehabil Med. 1971;3(3):131-7. No abstract available.
- Background: PubMed 4810651Nepomuceno CS, Miller JM 3rd. Shoulder arthrography in hemiplegic patients. Arch Phys Med Rehabil. 1974 Feb;55(2):49-51. No abstract available.
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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.
Tai Ryoon Han, MD, PhD principal investigator
Seoul National University College of Medicine
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 Hemiplegia, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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 30 Sep 2011. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography (time frame: within one month after enrollment). 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 NCT00998868, which also lists 37 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 30 Sep 2011.