| October 20, 2009 |
| September 23, 2011 |
| January 2008 |
| April 2010 (final data collection date for primary outcome measure) |
| Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography [ Time Frame: within one month after enrollment ] [ Designated as safety issue: No ] 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. |
| rotator cuff tear of the hemiplegic shoulder, confirmed by ultrasonography [ Time Frame: within one month after enrollment ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT00998868 on ClinicalTrials.gov Archive Site |
- Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography [ Time Frame: within one month after enrollment ] [ Designated as safety issue: No ]
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.
- Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination [ Time Frame: within one month after enrollment ] [ Designated as safety issue: No ]
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.
- Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System [ Time Frame: within one month after enrollment ] [ Designated as safety issue: No ]
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.
|
- rotator cuff tear of the unaffected shoulder, confirmed by ultrasonography [ Time Frame: within one month after enrollment ] [ Designated as safety issue: No ]
- subluxation of the glenohumeral joint, confirmed by Roentgenogram [ Time Frame: within one month after enrollment ] [ Designated as safety issue: No ]
- muscle strength, measured by physical examination, per Medical Research Council Muscle Strength grading system [ Time Frame: within one month after enrollment ] [ Designated as safety issue: No ]
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| Not Provided |
| Not Provided |
| |
| Rotator Cuff Tears in Hemiplegic Shoulder |
| 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. |
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. |
| Observational |
Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Not Provided |
| Not Provided |
| Probability Sample |
university hospital, department of rehabilitation medicine admitted patients due to hemiplegia |
| Hemiplegia |
| Not Provided |
| hemiplegia
patients with hemiplegia, without other musculoskeletal disorders of the shoulder |
- 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. Review.
- Sano 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.
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- Najenson 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.
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- Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder. 1972. J Bone Joint Surg Am. 2005 Jun;87(6):1399.
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- Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.
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- Jobe CM. Superior glenoid impingement. Orthop Clin North Am. 1997 Apr;28(2):137-43.
- Blevins FT. Rotator cuff pathology in athletes. Sports Med. 1997 Sep;24(3):205-20. Review.
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- Perry SM, McIlhenny SE, Hoffman MC, Soslowsky LJ. Inflammatory and angiogenic mRNA levels are altered in a supraspinatus tendon overuse animal model. J Shoulder Elbow Surg. 2005 Jan-Feb;14(1 Suppl S):79S-83S.
- Lohr JF, Uhthoff HK. The microvascular pattern of the supraspinatus tendon. Clin Orthop Relat Res. 1990 May;(254):35-8.
- Rothman RH, Parke WW. The vascular anatomy of the rotator cuff. Clin Orthop Relat Res. 1965 Jul-Aug;41:176-86. No abstract available.
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- Soslowsky LJ, Malicky DM, Blasier RB. Active and passive factors in inferior glenohumeral stabilization: a biomechanical model. J Shoulder Elbow Surg. 1997 Jul-Aug;6(4):371-9.
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- Halder AM, Halder CG, Zhao KD, O'Driscoll SW, Morrey BF, An KN. Dynamic inferior stabilizers of the shoulder joint. Clin Biomech (Bristol, Avon). 2001 Feb;16(2):138-43.
- Niessen M, Janssen T, Meskers C, Koppe P, Konijnenbelt M, Veeger D. Kinematics of the contralateral and ipsilateral shoulder: a possible relationship with post-stroke shoulder pain. J Rehabil Med. 2008 Jun;40(6):482-6.
- Diederichsen LP, Nørregaard J, Dyhre-Poulsen P, Winther A, Tufekovic G, Bandholm T, Rasmussen LR, Krogsgaard M. The activity pattern of shoulder muscles in subjects with and without subacromial impingement. J Electromyogr Kinesiol. 2009 Oct;19(5):789-99. Epub 2008 Dec 4.
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- Pong YP, Wang LY, Wang L, Leong CP, Huang YC, Chen YK. Sonography of the shoulder in hemiplegic patients undergoing rehabilitation after a recent stroke. J Clin Ultrasound. 2009 May;37(4):199-205.
- Kim HA, Kim SH, Seo YI. Ultrasonographic findings of painful shoulders and correlation between physical examination and ultrasonographic rotator cuff tear. Mod Rheumatol. 2007;17(3):213-9. Epub 2007 Jun 20.
|
| |
| Completed |
| 51 |
| August 2010 |
| April 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- hemiplegia; unilateral weakness of sudden onset
- secondary to strokes or other brain lesions
- compatible with brain lesions confirmed by imaging studies
Exclusion Criteria:
- bilateral weakness
- any history of intensive trauma of the shoulder, reported
- preexisting musculoskeletal disorder of the shoulder
|
| Both |
| 20 Years to 90 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Korea, Republic of |
| |
| NCT00998868 |
| SNUH-RM-TRHan-RCTHS-01 |
| No |
| Sun Gun Chung, Seoul National University Hospital |
| Seoul National University Hospital |
| Not Provided
| Principal Investigator: |
Tai Ryoon Han, MD, PhD |
Seoul National University College of Medicine |
|
|
| Seoul National University Hospital |
| September 2011 |