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

NCT ID: NCT06944808

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-01-01

Brief Summary

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This study investigate the impact of Blood Flow Restriction Training and Electrostimulation Training on postoperative muscle atrophy and pain after elective total knee arthroplasty.

Detailed Description

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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.

Conditions

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Osteoarthritis Knees

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Sham-BFR + EMS

Intervention Type OTHER

Daily passive sham-BFR with a fixed pressure of 20mmHg in combination with electrical stimulation of the m. vastus lateralis and mediales

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.

Group Type EXPERIMENTAL

BFR + EMS

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Alexander Franz

Dr. med., B.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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2023_B

Identifier Type: -

Identifier Source: org_study_id

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