Osteoarthritis KneesNCT06944808
Impact of Blood Flow Restriction and Electrical Stimulation on Postoperative Muscle Atrophy and Pain After Total Knee Arthroplasty
A study testing BFR + EMS in people with Osteoarthritis Knees, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
This study investigate the impact of Blood Flow Restriction Training and Electrostimulation Training on postoperative muscle atrophy and pain after elective total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Knees
- What is being tested?
- BFR + EMS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for elective total knee arthroplasty
- Understanding of the study and ability for informed consent
Who cannot join
- Open wounds of the lower extremities
- Stents or bypasses on the location of pressure application
- Sickle Cell Anemia
Trial locations and contacts
1 site in 1 country.
About this study
This study investigate the impact of Blood Flow Restriction Training and Electrostimulation Training on postoperative muscle atrophy and pain after elective total knee arthroplasty.
Read the 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.
- Conditions
- Osteoarthritis Knees
- Being tested
- Sham-BFR + EMS, BFR + EMS
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham-BFR + EMSOther
Daily passive sham-BFR with a fixed pressure of 20mmHg in combination with electrical stimulation of the m. vastus lateralis and mediales
BFR + EMSOther
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
| Study group | Role | What they receive |
|---|---|---|
| Sham-BFR + Electrical Stimulation | Active comparator | Patients received a daily postoperative passive therapy with a sham-BFR intervention (20mmHg) and electrical stimulation of the M. vastus laterals and mediales. Receives: Other: Sham-BFR + EMS |
| BFR + Electrical Stimulation | Experimental | 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. Receives: Other: BFR + EMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Visual Analog Scale (0-100mm)
Measured: Pre- to 6 week Post-OP
Muscle Mass
Sonographic measure of the diameter of the M. vastus mediales and lateralis
Measured: Pre- to 6 week Post-OP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Sep 2023
- Primary completion31 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis KneesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Franz, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944808
- Sponsor's protocol ID
- 2023_B
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Blood Flow Restriction and Electrical Stimulation on Postoperative Muscle Atrophy and Pain After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06944808
- Acronym / sponsor ID
- 2023_B
- Conditions
- Osteoarthritis Knees
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham-BFR + Electrical Stimulation | Active comparator | Other: Sham-BFR + EMSPatients received a daily postoperative passive therapy with a sham-BFR intervention (20mmHg) and electrical stimulation of the M. vastus laterals and mediales. |
| BFR + Electrical Stimulation | Experimental | Other: BFR + EMSPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for elective total knee arthroplasty
- Understanding of the study and ability for informed consent
Key exclusion criteria (3 listed)
- Open wounds of the lower extremities
- Stents or bypasses on the location of pressure application
- Sickle Cell Anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham-BFR + EMSDaily passive sham-BFR with a fixed pressure of 20mmHg in combination with electrical stimulation of the m. vastus lateralis and mediales | Other | Sham-BFR + Electrical Stimulation |
| BFR + EMSDaily 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 | Other | BFR + Electrical Stimulation |
Primary outcome
Postoperative Pain
Time frame: Pre- to 6 week Post-OP
Visual Analog Scale (0-100mm)
Muscle Mass
Time frame: Pre- to 6 week Post-OP
Sonographic measure of the diameter of the M. vastus mediales and lateralis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR + EMS in people with Osteoarthritis Knees, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: Pre- to 6 week Post-OP). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.