ClinicalTrials.gov
ClinicalTrials.gov Menu

Rehabilitation: Closed-Chain Exercises for Rotator Cuff Tears (CERCT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02750176
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Lori Michener, University of Southern California

Brief Summary:
A single arm design will be used to assess the feasibility and preliminary efficacy of a closed-chain rehabilitation protocol for patients with full thickness rotator cuff tears of the shoulder. Full thickness rotator cuff tears will be documented using MRI or ultrasound images. 30 participants will be recruited for this study. The rehabilitation protocol will include two stages: stage 1, physical therapy, and stage 2, gym program. Stage I will include a total number of session between 12 and 24. The number of session included in stage 2, will depend on the total number of session completed during stage 1. The total duration of both stages will 5 months.

Condition or disease Intervention/treatment Phase
Full Thickness Rotator Cuff Tear Other: Closed chain exercises Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rehabilitation of Patients With Full-thickness Rotator Cuff Tears: Planning and Pilot Study for Feasibility and Efficacy
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CERCT
Closed chain exercises
Other: Closed chain exercises
Closed-chain strengthening will be performed with the shoulder moving over a fixed hand. Resistance will be provided by body weight against gravity. To off-load and progress the amount of body-weight resistance, elastic bands will be used to support body weight using a exercise frame. Patients will perform 6 exercises.




Primary Outcome Measures :
  1. Feasibility - recruitment [ Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks ]
    Recruit 65% of the patients with rotator cuff tears that come to the USC PT Associate clinic for physical therapy treatment or patients that are seen at the physician office and are referred for physical therapy treatment.

  2. Patient Specific Functional Scale (PSFS) [ Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks ]
  3. Penn Shoulder Score (Penn) [ Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks ]

Secondary Outcome Measures :
  1. Feasibility - retention [ Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks ]
    The goal is to retain at least 75% of the participants enrolled.

  2. Quick Disabilities of the Arm Shoulder Hand (QDASH) scale [ Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks ]
  3. Global Rating of Change (GRoC) scale [ Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks ]
  4. Numeric Pain Rating Scale (NPRS) [ Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks ]
  5. American Shoulder and Elbow Surgeon Patient-report (ASES) scale [ Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks ]
  6. Shoulder pain-free active elevation range of motion [ Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks ]
  7. Shoulder elevation strength [ Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks ]
  8. Shoulder external rotation strength [ Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks ]
  9. Patient Acceptable Symptom State (PASS) score [ Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Full-thickness rotator cuff tears - confirmed by ultrasound (US) or magnetic resonance imagining (MRI)
  • Symptomatic for > 3 months
  • Reduction in shoulder function:

Patient satisfaction with use of their shoulder: ≤ 7/10 (10 = fully satisfied) OR Penn Function Subscale Score ≤ 40/60 (60 = full function)

Exclusion Criteria:

  • Physical therapy for current shoulder symptoms within last 3 months
  • Previous shoulder surgery on the involved shoulder
  • Cervical radiculopathy
  • Undergoing treatment for active cancer
  • Cardiovascular, pulmonary, neurological disease with physician limitations on exercise
  • Uncontrolled high blood pressure (> systolic above 90, diastolic above 140)
  • Unstable shoulder - primary diagnosis
  • Unable to complete up to 5 months of treatment at the clinic

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): NCT02750176


Contacts
Contact: Federico Pozzi, PT, PhD 3232245032 pozzi@usc.edu
Contact: Hillary Plummer, ATC, PhD 3232245032 hplummer@usc.edu

Locations
United States, California
Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory Recruiting
Los Angeles, California, United States, 90089
Contact: Federico Pozzi, PT, PhD    323-224-5032    pozzi@usc.edu   
Contact: Hillary Plummer, ATC, PhD    323-224-5032    hplummer@usc.edu   
Principal Investigator: Lori Michener, PhD, PT, ATC, SCS         
Sub-Investigator: Hillary Plummer, ATC, PhD         
Sub-Investigator: Federico Pozzi, PT, PhD         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Lori Michener, PT, ATC, PhD University of Southern California

Responsible Party: Lori Michener, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02750176     History of Changes
Other Study ID Numbers: HS-15-00771
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lori Michener, University of Southern California:
Rehabilitation
Closed chain exercises

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries