The Natural History of Asymptomatic Rotator Cuff Tears

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00923858
First received: June 16, 2009
Last updated: April 11, 2013
Last verified: April 2013

June 16, 2009
April 11, 2013
July 2005
July 2015   (final data collection date for primary outcome measure)
Standardized Shoulder Ultrasound & Radiographs [ Time Frame: Annually ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00923858 on ClinicalTrials.gov Archive Site
Patient completes ASES & MOS-26 [ Time Frame: Annually ] [ Designated as safety issue: No ]
Same as current
Physical Examination by the study coordinator [ Time Frame: Annually ] [ Designated as safety issue: No ]
Not Provided
 
The Natural History of Asymptomatic Rotator Cuff Tears
Asymptomatic Cuff Tears: A Model for Pain Development - Part B

The purpose of this project is to provide information which can help us understand what happens over time to rotator cuff tears. In this study, the investigators will follow a population of people with rotator cuff tears that do not hurt (asymptomatic) and to establish the probability that an asymptomatic rotator cuff tear, identified in the context of contralateral symptoms, will become symptomatic over time. To determine with ultrasound the probability that a rotator cuff tear will enlarge over time. To determine if symptom progression correlates with enlargement of the rotator cuff tear and/or degenerative changes on radiographs. In order to obtain data, study subjects will be recalled for follow-up at 1 year time points over a 5 year period. The study subjects will have repeat physical exam, ultrasound and radiographic examinations. A control group of normal patients will also be followed for comparison.

The specific aims of our study are:

  1. To determine the probability that an asymptomatic rotator cuff tear will become symptomatic over time.
  2. To determine which epidemiological factors correlate with symptomatic progression.
  3. To determine if symptomatic progression correlates with enlargement of the rotator cuff tear as determined at sonography.
  4. To determine the value of routine sonographic scanning of the asymptomatic shoulder.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients are recruited from ultrasound and orthopaedic surgeon's clinic.

Rotator Cuff Tear
Not Provided
  • Partial Thickness Tear
    no intervention
  • Full Thickness Tear
    no intervention
  • No Tear - Control Group
    no intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
405
July 2015
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Had an ultrasound examination to investigate shoulder pain.
  • Discovered to have a partial or full-thickness rotator cuff tear on the"asymptomatic" contralateral side.
  • Verified as being asymptomatic at the initiation of this study.
  • Have no history of trauma and remain injury free during the duration of the study.
  • 18 years or older.

Exclusion Criteria:

  • Any pain (greater than 3/10 on the visual analog pain scale)either previous to or at the time of initiation of the study.
  • Patients who have had a traumatic episode to their asymptomatic shoulder during the intervening time period.
  • Patients with a medical condition such as inflammatory arthropathy, rheumatoid arthritis, psoriatic arthritis, or Lupus which can alter the natural history of rotator cuff disease.
  • Patients who have sought medical attention for problems of the shoulder (includes instability, arthritis, trauma, etc.).
  • Use of the upper extremity for weight bearing.
  • Routinely take NSAIDs or pain medication.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00923858
IRB# 201103230, 5R01AR051026
No
Washington University School of Medicine
Washington University School of Medicine
  • National Institutes of Health (NIH)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Ken Yamaguchi, MD Washington University School of Medicine
Washington University School of Medicine
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP