CompletedNot Applicable

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

Switzerland30 participantsStarted 2023-03-01

Plain-language 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

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Pressure and Pain Treshold (Wagner FPX)

Timeframe: Pre and post training as well as in week 1 of training

Trial details

NCT IDNCT06699264

SponsorPraxisklinik Rennbahn AG

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-21

View on ClinicalTrials.gov More Anterior Cruciate Ligament Injury trials