Blood Flow Restriction Exercise-induced Hypoalgesia

Официальное название

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

Обзор

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).

Вмешательства

• Другое 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).
• Устройство 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

Первичные конечные точки

• Pressure pain threshold (PPT) [Срок оценки: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)]
• Condicionated pain modulation (CPM) [Срок оценки: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)]

Вторичные конечные точки (4)

• Pain intensity and distribution [Срок оценки: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)]
• Kinesiophobia [Срок оценки: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)]
• Self-reported upper extremity disability [Срок оценки: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)]
• Self-reported quality of life [Срок оценки: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Clínica RedSalud Mayor — Temuco

Публикации

• 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

Идентификаторы

NCT: NCT06924112 · P-5.2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗