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Early Range of Motion Following Arthroscopic Rotator Cuff Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845715
First Posted: February 18, 2009
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Augustus Mazzocca, UConn Health
  Purpose
The purpose of this study is to investigate whether there is a difference in the quality of life, ability to return to functioning (back to everyday life), the amount of experienced pain in patients who immediately move their shoulder versus patient who delay moving their shoulder after arthroscopic rotator cuff repair. We are also interested in whether there is a difference in the healing rates between these two groups.

Condition Intervention
Rotator Cuff Disease Other: Early motion Other: Standard motion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Early Range of Motion on Clinical Outcomes, Patient Satisfaction, and Cuff Integrity Following Arthroscopic Rotator Cuff Repair. A Prospective Randomized Study.

Further study details as provided by Augustus Mazzocca, UConn Health:

Primary Outcome Measures:
  • Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 6 month post surgery ]

Enrollment: 73
Study Start Date: July 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Early motion Other: Early motion
Early referral to physical therapy for range of motion (2 days post)
Standard motion Other: Standard motion
Standard referral to physical therapy for range of motion (4 weeks post)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who are between 18 years and 70 years of age
  • full thickness rotator cuff tear on ultrasound and MRI
  • failed conservative management

Exclusion Criteria:

  • concomitant pathology including massive rotator cuff tears that extend into the subscapularis or the teres minor and all co-existing labral pathology
  • history of neuromuscular or degenerative disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845715


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Donaghue Medical Research Foundation
Investigators
Principal Investigator: Augustus D Mazzocca UConn Health
  More Information

Responsible Party: Augustus Mazzocca, Professor, UConn Health
ClinicalTrials.gov Identifier: NCT00845715     History of Changes
Other Study ID Numbers: 08-311-3
DF08-13
First Submitted: February 13, 2009
First Posted: February 18, 2009
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Augustus Mazzocca, UConn Health:
rotator cuff
rehabilitation
range of motion