The Effect of Cross-Education on Shoulder Arthroscopy

NCT ID: NCT04470570

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-13
• Study Completion Date: 2020-10-30

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.

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries; Rotator Cuff Repair

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Cross-Education

Intervention Type: OTHER

1\) Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.

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.

Group Type: EXPERIMENTAL

Cross-Education

Intervention Type: OTHER

1\) Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.

Blood-Flow Restriction Training

Intervention Type: OTHER

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.

Interventions

Cross-Education

1\) Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Banffy, MD

Director, Orthopedic Sports Medicine Fellowship

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael B Banffy, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Kerlan-Jobe Institute

Locations

Cedars-Sinai Kerlan-Jobe Institute

Los Angeles, California, United States

Countries

United States

Other Identifiers

STUDY00000737

Identifier Type: -

Identifier Source: org_study_id