Blood Flow Restriction Exercise-induced Hypoalgesia

April 4, 2025 updated by: José Casaña Granell, University of Valencia

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Chile
    • Cautín
      • Temuco, Cautín, Chile, 4800580
        • Clínica RedSalud Mayor
        • Contact:
          • Felipe Ponce-Fuentes, MSc
        • Contact:
        • Contact:
          • Jose Casaña, PhD
        • Contact:
          • Joaquin Calatayud, PhD
        • Contact:
          • Filip Struyf, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isometric exercises with BFR (Intervention A)
Participants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises with BFR
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 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.
Active Comparator: Isometric exercises alone (Intervention B)
Participants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises without BFR
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
Tampa Scale of Kinesiophobia (11 to 44 points)
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)
Shoulder Pain Disability Index (0 to 100%)
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)
Western Ontario Rotator Cuff Index (0 to 100%)
Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: Felipe Ponce-Fuentes, MSc, Universidad Mayor
  • Study Director: Jose Casaña, PhD, University of Valencia
  • Study Director: Joaquin Calatayud, PhD, University of Valencia
  • Study Director: Filip Struyf, PhD, Universiteit Antwerpen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

August 29, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-5.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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