Anterior Cruciate Ligament InjuryBFRNCT06699264
Effects of Low-intensity Strength Training With Concomitant Blood Flow Restriction on Pain Perception in Patients With Anterior Cruciate Ligament Surgery
A study testing Blood Flow Restriction Training and Training without BFR in people with Anterior Cruciate Ligament Injury, run by Praxisklinik Rennbahn AG at 1 site in Switzerland.
Trial summary
After surgical treatment of a tear of the anterior cruciate ligament, physiotherapeutic exercises are done as standard therapy. This is to achieve a rapid improvement in pain and knee function. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Blood Flow Restriction Training and Training without BFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2023to 21 Dec 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- It must be your first anterior cruciate ligament surgery
- You must be between 18 and 60 years old
- You must be able to successfully complete certain exercises
- The injury must have occurred no longer than 6 months ago
Who cannot join
- Injury in other ligaments in the knee and cartilage
- thrombosis
- infection
- high blood pressure (which is not treated with medication)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effekte Von Blood Flow Restriction Therapie Auf Das Schmerzempfinden Bei Patienten Mit Rekonstruktion Des Vorderen Kreuzbandes (Effects of Blood Flow Restriction Therapy on Pain Sensation in Patients With Anterior Cruciate Ligament Reconstruction)
After surgical treatment of a tear of the anterior cruciate ligament, physiotherapeutic exercises are done as standard therapy. This is to achieve a rapid improvement in pain and knee function. In this study, the Investigators examine how low-intensity strength training with simultaneous restriction of blood flow works and whether it is effective and well tolerated. For this purpose, a pressure cuff is applied to the leg during training. Participation in this study will last four weeks for each participant. The Investigators will invite participants for 11 study visits. One appointment will last about 30 minutes. If a participant decides to take part in the study, they will be randomly assigned to one of two groups. The participants will belong to either an experimental group or the control group. In the experimental group, the participants will be treated with the intervention method. The intervention method involves 4 weeks of low-intensity strength training with an additional pressure cuff on the leg, which should lead to improved adaptations to the muscle as well as a reduction in pain. In the control group, the participants will receive the same strength training only without the additional pressure cuff. The benefit is that in addition to the participants actual rehabilitation program, each participant will receive free training to build their muscles. This could contribute to an accelerated rehabilitation process and a faster build-up of strength as well as an improvement in pain. It is additionally possible that the participants will help future patients with their participation. The intervention method for strength training with simultaneous restriction of blood flow (Blood Flow Restriction Training) has been studied for some time. There is good evidence of improved muscle, tendon and pain adaptations in both healthy individuals and patients with ACL injury. Whether this training method also has an effect on pain perception will be investigated in this study.
Participants may experience side effects if they are treated with the intervention method (low-intensity strength training with simultaneous restriction of blood flow). The Investigators may not yet know all the risks and side effects of the intervention method. So far, the following risks and side effects are known:
- Temporay numbness
- Muscle soreness
- Pressure sensation
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Blood Flow Restriction Training, Training without BFR
- Keywords
- ACL injury, BFR, Blood flow restriction, Physiotherapy
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction TrainingOther
Pressure cuff is applied to the leg during training for low-load strength training with simultaneous restiction of blood flow
Training without BFROther
Strength training according to experimentral group without simultaneous restriction blood flow
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Group 1 (experimental group) will be trained with the intervention method (low-load strength training) using the Tourniquet Touch (VBM Medizintechnik GmbH Einsteinstrasse 1, 72172 Sulz a.N., Germany) Receives: Other: Blood Flow Restriction Training |
| Control Group | Active comparator | Group 2 (controll group) receives the same strength training only without simultaneous restriction blood flow. Receives: Other: Training without BFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Pressure and Pain Treshold (Wagner FPX)
The Wagner FPX (Wagner Instruments, Greenwich, CT 06836-1217 USA) is used to quantify and document sensitivity and pain thresholds through defined application of pressure. Pain sensitivity is measured in kgf/s at four pre-defined positions:
Position 1: dominant quadriceps muscles - centered on the muscle belly, 20 cm proximal to the proximal end of the patella Position 2: non-dominant quadriceps muscles - centered on the muscle belly, 20cm proximal to the proximal end of the patella Position 3: dominant m. biceps brachii - centered on the muscle belly, 10 cm proximal to the cubital fossa (= elbow bend) Position 4: non-dominant trapezius muscle (based on handedness) - centered on the muscle belly, 10 cm from the proximal end of the acromion in a direct line to the neck
Measured: From enrollment to the end of training at 4 weeks as well as in week 1 of training
Subjective Pain Measure (VAS score)
As a subjective measure of knee joint pain, the perceived pain in the knee joint was further assessed using a visual analogue scale (VAS). The patients were asked to remember the most intense pain they experienced in their knee joint over the last week and rate it on the VAS. In order to evaluate a functional transfer of pain reduction, pain during a functional task (climbing stairs) was also assessed using VAS before and after the 4-week training intervention.
Measured: From enrollment to the end of training at 4 weeks
Secondary outcomes (2)
Legpress 10-repition maximum voluntary contraction test (HUMAC NORM Isokinetic Dynamometer By CSMi)
Lower extremity MVC is measured using the HUMAC NORM Isokinetic Dynamometer By CSMi (CSMi, Stoughton, MA 02072, United States) in Nm during a 90° knee-bend legpress. Participants perform 10 repitions with maximum force.
Measured: From enrollment to the end of training at 4 weeks as well as in week 3 of training
Rate of muscle thickness of the m. rectus femoris in mm
The muscle thickness of the m. rectus femoris is measured using an ultrasound device (Esaote MyLab Touch, Esaote SPA Genova GE, Italy)
Measured: From enrollment to the end of training at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Mar 2023
- Primary completion21 Dec 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Praxisklinik Rennbahn AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699264
- Sponsor's protocol ID
- 2023-00151
- Other IDs
- Forschungsförderung Nr. 106, 2023
- Acronym
- BFR
- Status last verified
- Dec 2025
- First submitted
- 13 Nov 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sensitive Patient Data
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effekte Von Blood Flow Restriction Therapie Auf Das Schmerzempfinden Bei Patienten Mit Rekonstruktion Des Vorderen Kreuzbandes (Effects of Blood Flow Restriction Therapy on Pain Sensation in Patients With Anterior Cruciate Ligament Reconstruction)
- ClinicalTrials.gov ID
- NCT06699264
- Acronym / sponsor ID
- BFR / 2023-00151
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- ACL injury, BFR, Blood flow restriction, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Praxisklinik Rennbahn AGUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 21 Nov 2024 (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.
After surgical treatment of a tear of the anterior cruciate ligament, physiotherapeutic exercises are done as standard therapy. This is to achieve a rapid improvement in pain and knee function. In this study, the Investigators examine how low-intensity strength training with simultaneous restriction of blood flow works and whether it is effective and well tolerated. For this purpose, a pressure cuff is applied to the leg during training. Participation in this study will last four weeks for each participant. The Investigators will invite participants for 11 study visits. One appointment will last about 30 minutes. If a participant decides to take part in the study, they will be randomly assigned to one of two groups. The participants will belong to either an experimental group or the control group. In the experimental group, the participants will be treated with the intervention method. The intervention method involves 4 weeks of low-intensity strength training with an additional pressure cuff on the leg, which should lead to improved adaptations to the muscle as well as a reduction in pain. In the control group, the participants will receive the same strength training only without the additional pressure cuff. The benefit is that in addition to the participants actual rehabilitation program, each participant will receive free training to build their muscles. This could contribute to an accelerated rehabilitation process and a faster build-up of strength as well as an improvement in pain. It is additionally possible that the participants will help future patients with their participation. The intervention method for strength training with simultaneous restriction of blood flow (Blood Flow Restriction Training) has been studied for some time. There is good evidence of improved muscle, tendon and pain adaptations in both healthy individuals and patients with ACL injury. Whether this training method also has an effect on pain perception will be investigated in this study.
Participants may experience side effects if they are treated with the intervention method (low-intensity strength training with simultaneous restriction of blood flow). The Investigators may not yet know all the risks and side effects of the intervention method. So far, the following risks and side effects are known:
- Temporay numbness
- Muscle soreness
- Pressure sensation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Blood Flow Restriction TrainingGroup 1 (experimental group) will be trained with the intervention method (low-load strength training) using the Tourniquet Touch (VBM Medizintechnik GmbH Einsteinstrasse 1, 72172 Sulz a.N., Germany) |
| Control Group | Active comparator | Other: Training without BFRGroup 2 (controll group) receives the same strength training only without simultaneous restriction blood flow. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- It must be your first anterior cruciate ligament surgery
- You must be between 18 and 60 years old
- You must be able to successfully complete certain exercises
- The injury must have occurred no longer than 6 months ago
Key exclusion criteria (4 listed)
- Injury in other ligaments in the knee and cartilage
- thrombosis
- infection
- high blood pressure (which is not treated with medication)
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 |
|---|---|---|
| Blood Flow Restriction TrainingPressure cuff is applied to the leg during training for low-load strength training with simultaneous restiction of blood flow | Other | Experimental Group |
| Training without BFRStrength training according to experimentral group without simultaneous restriction blood flow | Other | Control Group |
Primary outcome
Rate of Pressure and Pain Treshold (Wagner FPX)
Time frame: From enrollment to the end of training at 4 weeks as well as in week 1 of training
The Wagner FPX (Wagner Instruments, Greenwich, CT 06836-1217 USA) is used to quantify and document sensitivity and pain thresholds through defined application of pressure. Pain sensitivity is measured in kgf/s at four pre-defined positions: Position 1: dominant quadriceps muscles - centered on the muscle belly, 20 cm proximal to the proximal end of the patella Position 2: non-dominant quadriceps muscles - centered on the muscle belly, 20cm proximal to the proximal end of the patella Position 3: dominant m. biceps brachii - centered on the muscle belly, 10 cm proximal to the cubital fossa (= elbow bend) Position 4: non-dominant trapezius muscle (based on handedness) - centered on the muscle belly, 10 cm from the proximal end of the acromion in a direct line to the neck
Subjective Pain Measure (VAS score)
Time frame: From enrollment to the end of training at 4 weeks
As a subjective measure of knee joint pain, the perceived pain in the knee joint was further assessed using a visual analogue scale (VAS). The patients were asked to remember the most intense pain they experienced in their knee joint over the last week and rate it on the VAS. In order to evaluate a functional transfer of pain reduction, pain during a functional task (climbing stairs) was also assessed using VAS before and after the 4-week training intervention.
2 secondary outcomes
Legpress 10-repition maximum voluntary contraction test (HUMAC NORM Isokinetic Dynamometer By CSMi)
Time frame: From enrollment to the end of training at 4 weeks as well as in week 3 of training
Rate of muscle thickness of the m. rectus femoris in mm
Time frame: From enrollment to the end of training at 4 weeks
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 16 Sep 2026.
- Individual participant dataSharing planned: Undecided. Sensitive Patient Data
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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 Blood Flow Restriction Training and Training without BFR in people with Anterior Cruciate Ligament Injury, run by Praxisklinik Rennbahn AG at 1 site in Switzerland.
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 4 inclusion and 4 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 16 Sep 2026. 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 Switzerland. 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?
Rate of Pressure and Pain Treshold (Wagner FPX) (time frame: From enrollment to the end of training at 4 weeks as well as in week 1 of training). 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 16 Sep 2026.