The Effect of Cross-Education on Shoulder Arthroscopy

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04470570
• Other study ID #: STUDY00000737
• Status: Completed
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Repair
• Rotator Cuff Tears

Intervention

Other:
• Cross-Education
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
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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Kerlan-Jobe Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in strength of the shoulder at 6 weeks and 12 weeks	Strength of the shoulder will be assessed via hand-held dynamometer	pre-operative visit, 6 week post-operative visit, 12-week post-operative visit