Rotator Cuff Tears in Hemiplegic Shoulder - Study Results

Study Type:	Observational
Study Design:	Observational Model: Case-Only; Time Perspective: Cross-Sectional
Condition:	Hemiplegia

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: Jan, 2008 - Dec, 2009 Recruitment site: Seoul National University Eligible canditates from: inpatients in the department of rehabilitation medicine of the hospital Methods of recruitment: research physicians informed about the study to all eligible candidates and asked if they agreed to participate.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was designed to recruit hemiplegic patients of diverse degree of paresis with the same size. Because the crude distribution of the motor weakness was not even, the recruitment process adjusted the distribution of the severity of paresis, by recruiting patients of different motor strength in a consecutive way.

Reporting Groups

	Description
Hemiplegia	patients with hemiplegia, without other musculoskeletal disorders of the shoulder

Participant Flow: Overall Study

	Hemiplegia
STARTED	51 ^[1]
COMPLETED	51
NOT COMPLETED	0

[1]	>=10 for each muscle strength per MRC scale, after excluding the cases following exclusion criteria

Baseline Characteristics

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Reporting Groups

	Description
Hemiplegia	patients with hemiplegia, without other musculoskeletal disorders of the shoulder

Baseline Measures

	Hemiplegia
Number of Participants [units: participants]	51
Age [units: participants]
<=18 years	0
Between 18 and 65 years	24
>=65 years	27
Age [units: years] Mean ± Standard Deviation	63.37 ± 10.765
Gender [units: participants]
Female	26
Male	25
Region of Enrollment [units: participants]
Korea, Republic of	51

Outcome Measures

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1. Primary:

Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography [ Time Frame: within one month after enrollment ]

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2. Secondary:

Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography [ Time Frame: within one month after enrollment ]

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3. Secondary:

Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination [ Time Frame: within one month after enrollment ]

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4. Secondary:

Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System [ Time Frame: within one month after enrollment ]

Show Outcome Measure 4

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Tai Ryoon Han, MD, PhD./Professor
Organization: Seoul National University Hospital
phone: +82-2-2072-3218
e-mail: tairyoon@snu.ac.kr

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. 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.

Yu D. Shoulder pain in hemiplegia. Phys Med Rehabil Clin N Am. 2004 Aug;15(3):vi-vii, 683-97.

Bender L, McKenna K. Hemiplegic shoulder pain: defining the problem and its management. Disabil Rehabil. 2001 Nov 10;23(16):698-705. Review.

Gilmore PE, Spaulding SJ, Vandervoort AA. Hemiplegic shoulder pain: implications for occupational therapy treatment. Can J Occup Ther. 2004 Feb;71(1):36-46. Review.

Van Ouwenaller C, Laplace PM, Chantraine A. Painful shoulder in hemiplegia. Arch Phys Med Rehabil. 1986 Jan;67(1):23-6.

Joynt RL. The source of shoulder pain in hemiplegia. Arch Phys Med Rehabil. 1992 May;73(5):409-13.

Hakuno A, Sashika H, Ohkawa T, Itoh R. Arthrographic findings in hemiplegic shoulders. Arch Phys Med Rehabil. 1984 Nov;65(11):706-11.

Rizk 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.

Lo 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.

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.

Nepomuceno CS, Miller JM 3rd. Shoulder arthrography in hemiplegic patients. Arch Phys Med Rehabil. 1974 Feb;55(2):49-51. No abstract available.

Wolff 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.

Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder. 1972. J Bone Joint Surg Am. 2005 Jun;87(6):1399.

MacGillivray JD, Fealy S, Potter HG, O'Brien SJ. Multiplanar analysis of acromion morphology. Am J Sports Med. 1998 Nov-Dec;26(6):836-40.

Wang JC, Horner G, Brown ED, Shapiro MS. The relationship between acromial morphology and conservative treatment of patients with impingement syndrome. Orthopedics. 2000 Jun;23(6):557-9.

Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.

Yamaguchi K, Ditsios K, Middleton WD, Hildebolt CF, Galatz LM, Teefey SA. The demographic and morphological features of rotator cuff disease. A comparison of asymptomatic and symptomatic shoulders. J Bone Joint Surg Am. 2006 Aug;88(8):1699-704.

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.

Soslowsky LJ, Thomopoulos S, Tun S, Flanagan CL, Keefer CC, Mastaw J, Carpenter JE. Neer Award 1999. Overuse activity injures the supraspinatus tendon in an animal model: a histologic and biomechanical study. J Shoulder Elbow Surg. 2000 Mar-Apr;9(2):79-84.

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.

Rathbun JB, Macnab I. The microvascular pattern of the rotator cuff. J Bone Joint Surg Br. 1970 Aug;52(3):540-53. No abstract available.

Yuan J, Murrell GA, Wei AQ, Wang MX. Apoptosis in rotator cuff tendonopathy. J Orthop Res. 2002 Nov;20(6):1372-9.

Yuan J, Murrell GA, Trickett A, Wang MX. Involvement of cytochrome c release and caspase-3 activation in the oxidative stress-induced apoptosis in human tendon fibroblasts. Biochim Biophys Acta. 2003 Jun 17;1641(1):35-41.

Yuan J, Murrell GA, Trickett A, Landtmeters M, Knoops B, Wang MX. Overexpression of antioxidant enzyme peroxiredoxin 5 protects human tendon cells against apoptosis and loss of cellular function during oxidative stress. Biochim Biophys Acta. 2004 Jul 23;1693(1):37-45.

Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke. 1988 Dec;19(12):1497-500.

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.

Ovesen J, Nielsen S. Experimental distal subluxation in the glenohumeral joint. Arch Orthop Trauma Surg. 1985;104(2):78-81.

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.

Gold GE, Pappas GP, Blemker SS, Whalen ST, Campbell G, McAdams TA, Beaulieu CF. Abduction and external rotation in shoulder impingement: an open MR study on healthy volunteers initial experience. Radiology. 2007 Sep;244(3):815-22. Epub 2007 Aug 9.

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.

Responsible Party:	Sun Gun Chung, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00998868 History of Changes
Other Study ID Numbers:	SNUH-RM-TRHan-RCTHS-01
Study First Received:	October 20, 2009
Results First Received:	August 15, 2010
Last Updated:	September 23, 2011
Health Authority:	Korea: Food and Drug Administration Korea: Ministry for Health, Welfare and Family Affairs