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The Effect of Cross-Education on Shoulder Arthroscopy

Primary Purpose

Rotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Repair

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cross-Education
Blood-Flow Restriction Training
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring biceps tenodesis, Cross-Education, Blood-Flow Restriction Training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years and older
  • Diagnosed with rotator cuff injury
  • Scheduled for rotator cuff surgery via shoulder arthroscopy

Exclusion Criteria:

  • Less than 18 years old
  • History of previous contra-lateral surgery or injury
  • Previous ipsi-lateral upper extremity surgery
  • History of shoulder osteoarthritis

Sites / Locations

  • Cedars-Sinai Kerlan-Jobe Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

Cross-Education Group

Cross-Education + Blood-Flow Restriction Group

Arm Description

This group will undergo a standardized rehabilitation protocol of the involved shoulder only.

This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side.

This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side with blood-flow restriction simultaneously.

Outcomes

Primary Outcome Measures

Change in strength of the shoulder at 6 weeks and 12 weeks
Strength of the shoulder will be assessed via hand-held dynamometer

Secondary Outcome Measures

Full Information

First Posted
July 7, 2020
Last Updated
March 30, 2021
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04470570
Brief Title
The Effect of Cross-Education on Shoulder Arthroscopy
Official Title
The Effects of Cross-Education and Blood Flow Restriction Study on Patients Undergoing Shoulder Arthroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to examine the effectiveness of a strength training protocol on the uninjured upper extremity either alone or with the addition of blood flow restriction (BFR) training on subjects who have undergone shoulder arthroscopy.
Detailed Description
The purpose of this study is to examine the effectiveness of a strength training protocol on the uninjured limb either alone or with the addition of blood flow restriction (BFR) training on the status of the injured limb post shoulder arthroscopy. Patients will be randomized into one of three standardized physical therapy (PT) groups after shoulder arthroscopy: Control group (CON), Strength Training on the uninvolved shoulder (STR), strength training with the BFR on the uninvolved shoulder (BFR). All three patient groups will follow a standardized PT rehab protocol that is usual standard of care on the involved shoulder. The STR and BFR group will follow a typical standard of care rehab protocol to the uninvolved side to investigate the potential effects of cross-education. Isometric strength will be assessed utilizing handheld dynamometry (HHD) at Kerlan-Jobe during their regularly scheduled pre-operative and follow-up visits. Patients age 18 and older undergoing shoulder arthroscopy for rotator cuff repair and/or biceps tenodesis. The study includes 3 visits which are standard of care pre-operative and post-operative visits. The duration of the study will be 14 weeks. 2 weeks to allow for a pre-op baseline strength assessment and 12 weeks post-op for the final assessment during the patients routine follow-up visit. Physical Therapy will be standardized for all three groups in terms of frequency and rehabilitation protocol. The only exercises that will be added will be to the intervention groups on the uninvolved side. Patients will present to physical therapy 2-3 times/week during the duration of the study regardless of their group allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Repair
Keywords
biceps tenodesis, Cross-Education, Blood-Flow Restriction Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will undergo a standardized rehabilitation protocol of the involved shoulder only.
Arm Title
Cross-Education Group
Arm Type
Experimental
Arm Description
This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side.
Arm Title
Cross-Education + Blood-Flow Restriction Group
Arm Type
Experimental
Arm Description
This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side with blood-flow restriction simultaneously.
Intervention Type
Other
Intervention Name(s)
Cross-Education
Intervention Description
1) Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.
Intervention Type
Other
Intervention Name(s)
Blood-Flow Restriction Training
Intervention Description
1) Blood Flow Restriction: A type of resistance training using a blood-pressure like cuff that partially occludes venous blood flow to induce various neurohormonal effects and allows strength gains to be achieved at very low loads of resistance.
Primary Outcome Measure Information:
Title
Change in strength of the shoulder at 6 weeks and 12 weeks
Description
Strength of the shoulder will be assessed via hand-held dynamometer
Time Frame
pre-operative visit, 6 week post-operative visit, 12-week post-operative visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years and older Diagnosed with rotator cuff injury Scheduled for rotator cuff surgery via shoulder arthroscopy Exclusion Criteria: Less than 18 years old History of previous contra-lateral surgery or injury Previous ipsi-lateral upper extremity surgery History of shoulder osteoarthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Banffy, MD
Organizational Affiliation
Cedars-Sinai Kerlan-Jobe Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Kerlan-Jobe Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Data will be available for 6 months after the study has been published.

Learn more about this trial

The Effect of Cross-Education on Shoulder Arthroscopy

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