Rotator Cuff Tears in Hemiplegic Shoulder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun Gun Chung, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00998868
First received: October 20, 2009
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

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


Condition
Hemiplegia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Observational Study to Evaluate the Prevalence of Rotator Cuff Tears in Hemiplegic Shoulders

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 51
Study Start Date: January 2008
Study Completion Date: August 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
hemiplegia
patients with hemiplegia, without other musculoskeletal disorders of the shoulder

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998868

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Tai Ryoon Han, MD, PhD Seoul National University College of Medicine
  More Information

Publications:

Responsible Party: Sun Gun Chung, Professor, 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

Keywords provided by Seoul National University Hospital:
Rotator Cuff
Tendinopathy
ultrasonography

Additional relevant MeSH terms:
Hemiplegia
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014