Blood Flow Restriction Training For The Treatment Of Lateral Epicondylopathy (EPIC-BFR)

Technical University of Munich

Status: Enrolling

Conditions: Blood Flow Restriction Therapy; BFR; Epicondylitis of the Elbow; Elbow, Tennis; Elbow Tendinopathy; Lateral Epicondylitis

Treatments: Procedure: sham-Blood Flow Restriction; Procedure: Blood Flow Restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT07172568

245/21 S-NP

Details and patient eligibility

About

The study aims to evaluate the effectiveness of Blood Flow Restriction Training for the treatment of lateral elbow epicondylopathy.

Full description

1. To test a non-invasive, rapid treatment option for epicondylopathia humeri radialis for its effectiveness, Blood Flow Restriction (BFR) training will be supplemented to the applied exercise therapy. In BFR training, blood flow to the muscle is reduced by tying off the limb to be trained, e.g. with a blood pressure cuff, to achieve mechanical compression of the underlying blood vessels. This results in increased accumulation of blood in the capillary bed distal to the pressure cuff. Although isolated adverse effects have been reported, based on the current literature, it can be assumed that BFR training is comparable to conventional training in terms of safety for the user. Regarding the effect of BFR applications, it has been shown that even BFR without additional training measures can reduce muscle atrophy occurring during immobilization. A systematic literature review confirmed the positive effect of BFR augmented strength training in terms of strength development as well as muscle gain. The first positive results of BFR training compared to conventional physiotherapy have already been shown in rehabilitation after replacement surgery of the anterior cruciate ligament and after treatment of a radius fracture. Therefore, there is a scientific interest to verify the effectivity of this method in another disease of the musculoskeletal system, epicondylopathia humeri radialis.

   Question: Does the implementation of a BFR-protocol in the physiotherapeutic treatment of epicondylopathia humeri radialis lead to a significantly pain relief and function improvement in the affected hand? Hypothesis: The implementation of a BFR-protocol in the physiotherapeutic treatment leads to a significantly pain relief an function improvement in comparison to a cohort without BFR.

2. All patients who meet the inclusion criteria will be informed about the study in the special consultation for shoulder and elbow diseases and asked whether they would like to participate and will receive a declaration of participation if they agree. Patients are informed in detail that participation is voluntary, and that non-participation will not result in any disadvantages for their treatment. Prior to the start of therapy, one of the above-mentioned study physicians will personally inform the patient about the risks and benefits of the study. After sufficient time for reflection, the corresponding declaration of participation is gone through with the patient, signed by both parties in case of consent and the patient receives a copy of it. After signing the participation form, an appointment will be made to start the six-week randomized physiotherapy (2x per week a 20min; group A: Physiotherapy + BFR while intermittently wearing the BFR cuff (Delfi Medical Innocation Inc., Vancouver, Canada) at 50% of arterial occlusion pressure analogous to previous studies; Group B Physiotherapy + sham-BFR (BFR cuff inflated to 20mmHg). Patients are informed that they can discontinue therapy without giving a reason.

Physiotherapy treatment will be performed according to the current evidence-based protocol in the Department and Polyclinic for Sports Orthopedics of the Klinikum rechts der Isar of the Technical University of Munich twice a week over a period of six weeks. Randomization will be done by the treating physiotherapist(s) before the first physiotherapy session. Before the start of the first therapy unit (T1), as well as after completion of the six-week intervention (T2), six weeks after completion of therapy (T3) and again 12 weeks aufter completion of the physiotherapeutic treatment (T4), both clinical examinations to assess the progress of therapy by a blinded study physician and the completion of a standardized questionnaire by the subject will take place. No travel or expense allowance is provided. During the clinical examination, the joint status as well as the clinical signs of epicondylopathia radialis humeri will be collected. Further data collection is performed by means of questionnaires.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of lateral epicondylitis
• duration of symptoms > 6 weeks
• failed physical therapy
• absence of x-ray abnormalities
• written and informed consent

Exclusion criteria

• prior joint infiltrations
• duration of symptoms > 12 months
• concomitant rheumatoid diseases
• concomitant elbow pathologies, including medial epicondylitis
• concomitant radicular symptoms of the cervical spine, shoulder or hand
• traumatic etiology of symptoms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

20mmHg pressure Blood Flow Restriction

Active Comparator group

Description:

The patients in the control group are wearing a blood-flow-restriction cuff proximal to the elbow with an applied pressure of just 20mmHg. Studies have shown that this amount of pressure has no impact. The control group remains blind using the cuff with low pressure. The therapy protocol is exactly the same as in the Interventional group.

Treatment:

Procedure: sham-Blood Flow Restriction

50% of Mean arterial blood pressure Blood Flow Restriction

Experimental group

Description:

The patients in the intervention group are wearing a blood-flow-restriction cuff proximal to the elbow with an applied pressure of 50% of the mean arterial blood pressure. The therapy protocol is exactly the same as in the control group.

Treatment:

Procedure: Blood Flow Restriction