Blood Flow Restriction Exercise-induced Hypoalgesia

NCT06924112 | Not Yet Recruiting DMC

• 1 other identifier: P-5.2025
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Rotator Cuff Injury; Rotator Cuff Tear; Rotator Cuff Repair

Keywords

blood flow restriction therapy; blood flow restriction training; exercise-induced hypoalgesia

Outcome Measures

Primary Outcomes (2)

• Pressure pain threshold (PPT)

  Pressure pain threshold will be taken bilaterally on the deltoid muscle and the upper trapezius muscle using a Wagner FPX25 pressure algometer (kg/cm2/sec)

  Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)

• Condicionated pain modulation (CPM)

  Condicionated pain modulation will be measured with a conditioning stimulus of inmersion of the hand contralateral to the operated shoulder in cold water (10°C). The bilateral deltoid and trapezius muscles before and after the conditioning stimulus will be measured using a Wagner FPX25 pressure algometer (kg/cm2/sec)

  Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)

Secondary Outcomes (4)

• Pain intensity and distribution

  Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)

• Kinesiophobia

  Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)

• Self-reported upper extremity disability

  Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)

• Self-reported quality of life

  Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)

Study Arms (2)

Isometric exercises with BFR (Intervention A)

EXPERIMENTAL

Participants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises with BFR

Other: Isometric exercises; Device: Isometric exercises with BFR

Isometric exercises alone (Intervention B)

ACTIVE COMPARATOR

Participants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises without BFR

Other: Isometric exercises

Interventions

Isometric exercises OTHER

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).

Isometric exercises alone (Intervention B); Isometric exercises with BFR (Intervention A)

Isometric exercises with BFR DEVICE

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 repetitions, with isometric contraction of 15 seconds followed by a rest period of 15 seconds, intensity with a load at 20-25% of the MVIC, rest period after each exercise of 2 minutes with cuff deflated (reperfusion), and pain level below 5 on the NPRS.

Isometric exercises with BFR (Intervention A)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Clínica RedSalud Mayor

Temuco, Cautín, 4800580, Chile

Location

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 33471547 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Felipe Ponce-Fuentes, MSc

  Universidad Mayor

  PRINCIPAL INVESTIGATOR

• Jose Casaña, PhD

  University of Valencia

  STUDY DIRECTOR

• Joaquin Calatayud, PhD

  University of Valencia

  STUDY DIRECTOR

• Filip Struyf, PhD

  Universiteit Antwerpen

  STUDY DIRECTOR

Central Study Contacts

Jose Casaña, PhD

CONTACT

+34656437371; jose.casana@uv.es

Felipe Ponce-Fuentes, MSc

CONTACT

+56954411974; felipe.poncef@umayor.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Opaque sealed envelopes
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physiotherapy

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: May 1, 2025
• Primary Completion: August 29, 2025
• Study Completion: September 30, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)