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NCT Number: NCT06924112

Blood Flow Restriction Exercise-induced Hypoalgesia

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).

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Key information

Conditions

Rotator Cuff Injury Rotator Cuff Injuries Rotator Cuff Repair Rotator Cuff Tear Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica RedSalud Mayor

Temuco, Cautín, 4800580, Chile

Location contact

Daniela Mansilla, MSc

CONTACT

[email protected]

+56996521664

Felipe Ponce-Fuentes, MSc

PRINCIPAL_INVESTIGATOR

Filip Struyf, PhD

SUB_INVESTIGATOR

Joaquin Calatayud, PhD

SUB_INVESTIGATOR

Jose Casaña, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Pressure pain threshold (PPT)

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

    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)

  2. Condicionated pain modulation (CPM)

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

    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)

Secondary outcomes

  1. Pain intensity and distribution

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

    Visual Analogue Scale (0 to 10 centimeters) and pain distribution map (number of areas)

  2. Kinesiophobia

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

    Tampa Scale of Kinesiophobia (11 to 44 points)

  3. Self-reported upper extremity disability

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

    Shoulder Pain Disability Index (0 to 100%)

  4. Self-reported quality of life

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

    Western Ontario Rotator Cuff Index (0 to 100%)

Study contacts

Contact information is provided by the study sponsor or research team.

Felipe Ponce-Fuentes, MSc

CONTACT

[email protected]

+56954411974

Jose Casaña, PhD

CONTACT

[email protected]

+34656437371

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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