Rotator Cuff Tears in Hemiplegic Shoulder

Hemiplegia Clinical Trial

Official title:

Observational Study to Evaluate the Prevalence of Rotator Cuff Tears in Hemiplegic Shoulders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998868
• Other study ID #: SNUH-RM-TRHan-RCTHS-01
• Status: Completed
• Phase: N/A
• First received: October 20, 2009
• Last updated: September 23, 2011
• Start date: January 2008
• Est. completion date: August 2010

Study information

• Verified date: September 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Ministry for Health and Welfare
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hemiplegia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	within one month after enrollment	No
Secondary	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.	within one month after enrollment	No
Secondary	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.	within one month after enrollment	No