Clinical trial NCT06788327: Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair
Official title: Comparing the Effectiveness of Blood Flow Restriction Therapy Versus Standard Exercise After Arthroscopic Rotator Cuff Repair: Protocol for the Multicenter S-TRONGER Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rotator Cuff Injury
Rotator Cuff Tears
Rotator Cuff Repair
Keywords: blood flow restriction therapy
blood flow restriction training
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine the effectiveness of postoperative standard exercises with blood flow restriction therapy (BFRT) versus standard exercises alone on shoulder muscle strength and mass in participants with surgically treated rotator cuff tear. It is presumed that the addition of BFRT will significantly improve the shoulder strength and muscle mass at the end of the intervention period compared to the group receiving only standard exercises.

Patients who agree to participate in this research will be randomly assigned to a control group (standard exercises alone) or an experimental group (standard rehabilitation with BFRT). The duration of the postoperative intervention will be 12 weeks. The primary variables will be the shoulder muscle strength and muscle mass. Secondary variables will be the active shoulder mobility, pain intensity, upper limb disability, and health-related quality of life. Results will be measured at 0, 4 and 12 weeks postoperative.


Eligibility criteria: Inclusion Criteria:

* Age between 40-65 years
* Symptomatic degenerative rotator cuff tear diagnosed by magnetic resonance imaging
* Undergoing arthroscopic rotator cuff repair
* Be able to read and understand Spanish

Exclusion Criteria:

* Massive irreparable rotator cuff tear
* Concomitant fracture
* Labral or nerve injury
* Suspicious of developing a frozen shoulder
* Revision surgery after rotator cuff repair
* Previous corticosteroid injection (\< 6 months)
* Recent surgery (\< 1 year) in the contralateral shoulder
* History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease, thrombophilia or clotting disorders
* Severe or uncontrolled hypertension, or any comorbid condition that impedes participants to complete the intervention

Primary outcomes:
measure: Shoulder muscle strength
timeFrame: 0, 4 and 12 weeks
measure: Shoulder muscle mass
timeFrame: 0, 4 and 12 weeks
Secondary outcomes:
measure: Active Range of Motion
timeFrame: 0, 4 and 12 weeks
measure: Pain intensity
timeFrame: 0, 4 and 12 weeks
measure: Self-reported upper limb disability
timeFrame: 0, 4 and 12 weeks
measure: Self-reported quality of life
timeFrame: 0, 4 and 12 weeks
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Clínica RedSalud Mayor
state: Cautín
Study officials:
affiliation: Universidad Mayor
name: Felipe Ponce-Fuentes, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.
citation: Lambert BS, Hedt C, Ankersen JP, Goble H, Taft C, Daum J, Karasch R, Moreno MR, McCulloch PC. Rotator cuff training with upper extremity blood flow restriction produces favorable adaptations in division IA collegiate pitchers: a randomized trial. J Shoulder Elbow Surg. 2023 Jun;32(6):e279-e292. doi: 10.1016/j.jse.2023.02.116. Epub 2023 Mar 17.
citation: Lambert B, Hedt C, Daum J, Taft C, Chaliki K, Epner E, McCulloch P. Blood Flow Restriction Training for the Shoulder: A Case for Proximal Benefit. Am J Sports Med. 2021 Aug;49(10):2716-2728. doi: 10.1177/03635465211017524. Epub 2021 Jun 10.
citation: Kjaer BH, Magnusson SP, Henriksen M, Warming S, Boyle E, Krogsgaard MR, Al-Hamdani A, Juul-Kristensen B. Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial. Am J Sports Med. 2021 Feb;49(2):321-331. doi: 10.1177/0363546520983823. Epub 2021 Jan 20.
citation: Kara D, Ozcakar L, Demirci S, Huri G, Duzgun I. Blood Flow Restriction Training in Patients With Rotator Cuff Tendinopathy: A Randomized, Assessor-Blinded, Controlled Trial. Clin J Sport Med. 2024 Jan 1;34(1):10-16. doi: 10.1097/JSM.0000000000001191. Epub 2023 Sep 14.
citation: Hughes L, Patterson SD. The effect of blood flow restriction exercise on exercise-induced hypoalgesia and endogenous opioid and endocannabinoid mechanisms of pain modulation. J Appl Physiol (1985). 2020 Apr 1;128(4):914-924. doi: 10.1152/japplphysiol.00768.2019. Epub 2020 Feb 27.
citation: Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Upper-extremity blood flow restriction: the proximal, distal, and contralateral effects-a randomized controlled trial. J Shoulder Elbow Surg. 2020 Jun;29(6):1267-1274. doi: 10.1016/j.jse.2020.02.003.