The Effect of Cross-Education on Shoulder Arthroscopy

February 6, 2024 updated by: Michael Banffy, MD, Cedars-Sinai Medical Center

The Effects of Cross-Education and Blood Flow Restriction Study on Patients Undergoing Shoulder Arthroscopy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90045
        • Cedars-Sinai Kerlan-Jobe Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
This group will undergo a standardized rehabilitation protocol of the involved shoulder only.
Experimental: Cross-Education Group
This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side.
Other: Cross-Education
1) Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.
Experimental: Cross-Education + Blood-Flow Restriction Group
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.
Other: Cross-Education
1) Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.
Other: Blood-Flow Restriction Training
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in strength of the shoulder at 6 weeks and 12 weeks
Time Frame: pre-operative visit, 6 week post-operative visit, 12-week post-operative visit
Strength of the shoulder will be assessed via hand-held dynamometer
pre-operative visit, 6 week post-operative visit, 12-week post-operative visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cedars-Sinai Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael B Banffy, MD, Cedars-Sinai Kerlan-Jobe Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00000737

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Data will be available for 6 months after the study has been published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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