Impact of Blood Flow Restriction and Electrical Stimulation on Postoperative Muscle Atrophy and Pain After Total Knee Arthroplasty

April 18, 2025 updated by: Alexander Franz, University Hospital, Bonn
This study investigate the impact of Blood Flow Restriction Training and Electrostimulation Training on postoperative muscle atrophy and pain after elective total knee arthroplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study invesigate the impact of passive blood flow restriction training and/or electrical stimulation training on postoperative muscle atrophy and pain after elective total knee arthroplasty.

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • Germany
    • NRW
      • Bonn, NRW, Germany, 53127
        • University Hospital Bonn

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:

  • Indication for elective total knee arthroplasty
  • Understanding of the study and ability for informed consent

Exclusion Criteria:

  • Open wounds of the lower extremities
  • Stents or bypasses on the location of pressure application
  • Sickle Cell Anemia

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sham-BFR + Electrical Stimulation
Patients received a daily postoperative passive therapy with a sham-BFR intervention (20mmHg) and electrical stimulation of the M. vastus laterals and mediales.
Other: Sham-BFR + EMS
Daily passive sham-BFR with a fixed pressure of 20mmHg in combination with electrical stimulation of the m. vastus lateralis and mediales
Experimental: BFR + Electrical Stimulation
Patients received a daily postoperative passive therapy with a BFR intervention (80% of the individual LOP) and electrical stimulation of the M. vastus laterals and mediales.
Other: BFR + EMS
Daily passive BFR with an individual pressure of 80% of the limb occlusion pressure in combination with electrical stimulation of the m. vastus lateralis and mediales

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: Pre- to 6 week Post-OP
Visual Analog Scale (0-100mm)
Pre- to 6 week Post-OP
Muscle Mass
Time Frame: Pre- to 6 week Post-OP
Sonographic measure of the diameter of the M. vastus mediales and lateralis
Pre- to 6 week Post-OP

Collaborators and Investigators

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

Sponsor

University Hospital, Bonn

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 (Actual)

September 1, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023_B

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

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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