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Effects of Low-intensity Strength Training With Concomitant Blood Flow Restriction on Pain Perception in Patients With Anterior Cruciate Ligament Surgery

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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06699264
Acronym
BFR
Enrollment
30
Registered
2024-11-21
Start date
2023-03-01
Completion date
2024-12-21
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injury

Keywords

ACL injury, BFR, Blood flow restriction, Physiotherapy

Brief 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. 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

Interventions

OTHERBlood Flow Restriction Training

Pressure cuff is applied to the leg during training for low-load strength training with simultaneous restiction of blood flow

OTHERTraining without BFR

Strength training according to experimentral group without simultaneous restriction blood flow

Sponsors

Praxisklinik Rennbahn AG
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Injury in other ligaments in the knee and cartilage * thrombosis * infection * high blood pressure (which is not treated with medication)

Design outcomes

Primary

MeasureTime frameDescription
Rate of Pressure and Pain Treshold (Wagner FPX)From enrollment to the end of training at 4 weeks as well as in week 1 of trainingThe 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)From enrollment to the end of training at 4 weeksAs 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.

Secondary

MeasureTime frameDescription
Legpress 10-repition maximum voluntary contraction test (HUMAC NORM Isokinetic Dynamometer By CSMi)From enrollment to the end of training at 4 weeks as well as in week 3 of trainingLower 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.
Rate of muscle thickness of the m. rectus femoris in mmFrom enrollment to the end of training at 4 weeksThe muscle thickness of the m. rectus femoris is measured using an ultrasound device (Esaote MyLab Touch, Esaote SPA Genova GE, Italy)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026