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Not yet recruiting NCT06924112

Blood Flow Restriction Exercise-induced Hypoalgesia

No phase Interventional Rotator Cuff Injury Rotator Cuff Tear Rotator Cuff Repair

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Isometric exercises, Isometric exercises with BFR.
Who it may be relevant to
Registry conditions: Rotator Cuff Injury, Rotator Cuff Tear, Rotator Cuff Repair. Basic parameters: 40 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Chile
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Exercise-induced Hypoalgesia Following Blood Flow Restriction in Rotator Cuff Repair Rehabilitation: a Randomized Crossover Clinical Trial

Overview

The goal of this crossover randomized clinical trial is to compare the acute effect on exercise-induced hypoalgesia (EIH) between isometric exercise with blood flow restriction (BFR) and isometric exercise alone in adults undergoing arthroscopic rotator cuff repair. It is presumed that the addition of BFR to isometric exercises induces a greater effect in EIH. Patients who agree to participate in this research will be randomly assigned to two intervention sequences (AB or BA), where intervention A (experimental) corresponds to isometric exercises with BFR, and intervention B (control) corresponds to isometric exercises alone. For one week, each participant attended two sessions, separated by a 72-hours wash-out period. The primary variables will be the pressure pain threshold (PPT) and conditioned pain modulation (CPM). Secondary variables will be the pain intensity and distribution, kinesiophobia, upper extremity disability, and quality of life. Results will be measured before intervention (T1, pre-intervention), immediate after intervention (T2, post-intervention 1) and 10 minutes after intervention (T3, post-intervention 2).

Interventions

  • Other Isometric exercises
    The three isometric exercises were performed without the addition of BFR following the best evidence recommendations. Each exercise was performed for 10 repetitions, with isometric contraction of 15 seconds followed by a rest period of 15 seconds, intensity with a load at 20-25% of the maximal voluntary isometric contraction (MVIC), rest period after each exercise of 2 minutes, and pain level below 5 on the verbal Numeric Pain Rating Scale (NPRS).
  • Device Isometric exercises with BFR
    Participants will perform three isometric exercises with BFR. An auto-regulated portable BFRT SmartCuffs® 3.0 Pro system with a 17-inch long and 5-inch-wide cuff (Smart Tools Plus, United States), placed on the most proximal part of the arm, will be used. The session will begin with a maximal occlusion test to personalize the occlusion pressure to the participant. The limb occlusion pressure (LOP) will be set at 60% of the maximum occlusion pressure. Each exercise was performed for 10 repetition

Primary outcome measures

  • Pressure pain threshold (PPT) [Time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)]
  • Condicionated pain modulation (CPM) [Time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)]
Secondary outcome measures (4)
  • Pain intensity and distribution [Time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)]
  • Kinesiophobia [Time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)]
  • Self-reported upper extremity disability [Time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)]
  • Self-reported quality of life [Time frame: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)]

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 RC tears, concomitant fracture, labral or nerve injury.
  • Suspicion of developing/diagnosis a frozen shoulder.
  • Revision surgery after RC repair.
  • Previous corticosteroid injection (< 1 year).
  • Recent surgery (< 1 year) in the contralateral shoulder.
  • A history of deep venous thrombosis/pulmonary embolism.
  • Peripheral vascular disease, thrombophilia or clotting disorders.
  • Severe or uncontrolled hypertension, or any comorbid condition that prevents participants from complete the intervention.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Chile · 1 center
  • Clínica RedSalud Mayor — Temuco

Publications

  • 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. PMID 32105522
  • Kuppens K, Struyf F, Nijs J, Cras P, Fransen E, Hermans L, Meeus M, Roussel N. Exercise- and Stress-Induced Hypoalgesia in Musicians with and without Shoulder Pain: A Randomized Controlled Crossover Study. Pain Physician. 2016 Feb;19(2):59-68. PMID 26815250
  • 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. PMID 31156448
  • Ogrezeanu DC, Lopez-Bueno L, Sanchis-Sanchez E, Suso-Marti L, Lopez-Bueno R, Nunez-Cortes R, Cruz-Montecinos C, Perez-Alenda S, Casana J, Gargallo P, Calatayud J. Exercise-induced hypoalgesia with end-stage knee osteoarthritis during different blood flow restriction levels: Sham-controlled crossover study. PM R. 2023 Dec;15(12):1565-1573. doi: 10.1002/pmrj.13076. Epub 2023 Dec 8. PMID 37796567
  • Korakakis V, Whiteley R, Epameinontidis K. Blood Flow Restriction induces hypoalgesia in recreationally active adult male anterior knee pain patients allowing therapeutic exercise loading. Phys Ther Sport. 2018 Jul;32:235-243. doi: 10.1016/j.ptsp.2018.05.021. Epub 2018 May 31. PMID 29879638
  • Rice D, Nijs J, Kosek E, Wideman T, Hasenbring MI, Koltyn K, Graven-Nielsen T, Polli A. Exercise-Induced Hypoalgesia in Pain-Free and Chronic Pain Populations: State of the Art and Future Directions. J Pain. 2019 Nov;20(11):1249-1266. doi: 10.1016/j.jpain.2019.03.005. Epub 2019 Mar 21. PMID 30904519
  • Vaegter HB, Jones MD. Exercise-induced hypoalgesia after acute and regular exercise: experimental and clinical manifestations and possible mechanisms in individuals with and without pain. Pain Rep. 2020 Sep 23;5(5):e823. doi: 10.1097/PR9.0000000000000823. eCollection 2020 Sep-Oct. PMID 33062901
  • Wewege MA, Jones MD. Exercise-Induced Hypoalgesia in Healthy Individuals and People With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. J Pain. 2021 Jan;22(1):21-31. doi: 10.1016/j.jpain.2020.04.003. Epub 2020 Jun 26. PMID 32599154

Identifiers

NCT: NCT06924112 · P-5.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗