NCT00998868

Brief Summary

The purpose of the study is to evaluate the prevalence of rotator cuff tears in the shoulders of hemiplegic patients of different severity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 22, 2011

Completed
Last Updated

September 30, 2011

Status Verified

September 1, 2011

Enrollment Period

2.2 years

First QC Date

October 20, 2009

Results QC Date

August 15, 2010

Last Update Submit

September 23, 2011

Conditions

Hemiplegia

Keywords

Rotator CuffTendinopathyultrasonography

Outcome Measures

Primary Outcomes (1)

  • 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.

    within one month after enrollment

Secondary Outcomes (3)

  • Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography

    within one month after enrollment

  • Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination

    within one month after enrollment

  • Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System

    within one month after enrollment

Study Arms (1)

hemiplegia

patients with hemiplegia, without other musculoskeletal disorders of the shoulder

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

university hospital, department of rehabilitation medicine admitted patients due to hemiplegia

You may qualify if:

  • hemiplegia; unilateral weakness of sudden onset
  • secondary to strokes or other brain lesions
  • compatible with brain lesions confirmed by imaging studies

You may not qualify if:

  • bilateral weakness
  • any history of intensive trauma of the shoulder, reported
  • preexisting musculoskeletal disorder of the shoulder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (37)

  • 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.

    PMID: 16551396BACKGROUND

  • 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. doi: 10.1016/s1058-2746(99)90092-7.

    PMID: 10633891BACKGROUND

  • Yu 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.

    PMID: 15219895BACKGROUND

  • Bender 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.

    PMID: 11732559BACKGROUND

  • Gilmore 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.

    PMID: 15015899BACKGROUND

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

    PMID: 3942479BACKGROUND

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

    PMID: 1580765BACKGROUND

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

    PMID: 6497618BACKGROUND

  • 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.

    PMID: 6712451BACKGROUND

  • 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. doi: 10.1016/s0003-9993(03)00408-8.

    PMID: 14669184BACKGROUND

  • 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.

    PMID: 5156175BACKGROUND

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

    PMID: 4810651BACKGROUND

  • 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. doi: 10.5435/00124635-200612000-00003.

    PMID: 17148619BACKGROUND

  • Neer 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.

    PMID: 15930554BACKGROUND

  • 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. doi: 10.1177/03635465980260061701.

    PMID: 9850788BACKGROUND

  • 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. doi: 10.3928/0147-7447-20000601-12.

    PMID: 10875415BACKGROUND

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

    PMID: 6825348BACKGROUND

  • 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. doi: 10.2106/JBJS.E.00835.

    PMID: 16882890BACKGROUND

  • Jobe CM. Superior glenoid impingement. Orthop Clin North Am. 1997 Apr;28(2):137-43. doi: 10.1016/s0030-5898(05)70274-1.

    PMID: 9113710BACKGROUND

  • Blevins FT. Rotator cuff pathology in athletes. Sports Med. 1997 Sep;24(3):205-20. doi: 10.2165/00007256-199724030-00009.

    PMID: 9327536BACKGROUND

  • 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.

    PMID: 10810684BACKGROUND

  • 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. doi: 10.1016/j.jse.2004.09.020.

    PMID: 15726091BACKGROUND

  • Lohr JF, Uhthoff HK. The microvascular pattern of the supraspinatus tendon. Clin Orthop Relat Res. 1990 May;(254):35-8.

    PMID: 2323147BACKGROUND

  • Rothman RH, Parke WW. The vascular anatomy of the rotator cuff. Clin Orthop Relat Res. 1965 Jul-Aug;41:176-86. No abstract available.

    PMID: 5832730BACKGROUND

  • 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.

    PMID: 5455089BACKGROUND

  • Yuan J, Murrell GA, Wei AQ, Wang MX. Apoptosis in rotator cuff tendonopathy. J Orthop Res. 2002 Nov;20(6):1372-9. doi: 10.1016/S0736-0266(02)00075-X.

    PMID: 12472255BACKGROUND

  • 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. doi: 10.1016/s0167-4889(03)00047-8.

    PMID: 12788227BACKGROUND

  • 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. doi: 10.1016/j.bbamcr.2004.04.006.

    PMID: 15276323BACKGROUND

  • Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke. 1988 Dec;19(12):1497-500. doi: 10.1161/01.str.19.12.1497.

    PMID: 3201508BACKGROUND

  • 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. doi: 10.1016/s1058-2746(97)90005-7.

    PMID: 9285877BACKGROUND

  • Ovesen J, Nielsen S. Experimental distal subluxation in the glenohumeral joint. Arch Orthop Trauma Surg (1978). 1985;104(2):78-81. doi: 10.1007/BF00454241.

    PMID: 4051701BACKGROUND

  • Halder AM, Halder CG, Zhao KD, O'Driscoll SW, Morrey BF, An KN. Dynamic inferior stabilizers of the shoulder joint. Clin Biomech (Bristol). 2001 Feb;16(2):138-43. doi: 10.1016/s0268-0033(00)00077-2.

    PMID: 11222932BACKGROUND

  • 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. doi: 10.2340/16501977-0201.

    PMID: 18509565BACKGROUND

  • Diederichsen LP, Norregaard 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. doi: 10.1016/j.jelekin.2008.08.006. Epub 2008 Dec 4.

    PMID: 19062307BACKGROUND

  • 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. doi: 10.1148/radiol.2443060998. Epub 2007 Aug 9.

    PMID: 17690321BACKGROUND

  • 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. doi: 10.1002/jcu.20573.

    PMID: 19253350BACKGROUND

  • 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. doi: 10.1007/s10165-007-0577-8. Epub 2007 Jun 20.

    PMID: 17564776BACKGROUND

MeSH Terms

Conditions

HemiplegiaTendinopathy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Results Point of Contact

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

Study Officials

  • Tai Ryoon Han, MD, PhD

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

January 1, 2008

Primary Completion

April 1, 2010

Study Completion

August 1, 2010

Last Updated

September 30, 2011

Results First Posted

September 22, 2011

Record last verified: 2011-09

Locations

KR(1)