Overview

This trial is active, not recruiting.

Condition rotator cuff disease
Treatments early motion, standard motion
Sponsor University of Connecticut Health Center
Collaborator Donaghue Medical Research Foundation
Start date July 2008
End date December 2012
Trial size 70 participants
Trial identifier NCT00845715, 08-311-3, DF08-13

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Other)
early motion
Early referral to physical therapy for range of motion (2 days post)
(Other)
standard motion
Standard referral to physical therapy for range of motion (4 weeks post)

Primary Outcomes

Measure
Western Ontario Rotator Cuff Index (WORC)
time frame: 6 month post surgery

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

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.
Principal investigator Augustus D Mazzocca
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by University of Connecticut Health Center.