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Completed

NCT Number: NCT04470570

The Effect of Cross-Education on 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.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rotator Cuff Repair Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Kerlan-Jobe Institute

Los Angeles, California, 90045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cross-education

Other
  • Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.

Blood-Flow Restriction Training

Other
  • 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 14, 2020
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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