Clinical trial NCT04470570: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Rotator Cuff Injuries
Rotator Cuff Repair
Keywords: biceps tenodesis
Cross-Education
Blood-Flow Restriction Training
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in strength of the shoulder at 6 weeks and 12 weeks
timeFrame: pre-operative visit, 6 week post-operative visit, 12-week post-operative visit
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Kerlan-Jobe Institute
state: California
Study officials:
affiliation: Cedars-Sinai Kerlan-Jobe Institute
name: Michael B Banffy, MD
role: PRINCIPAL_INVESTIGATOR
References: