Blood Flow Restriction Training For The Treatment Of Lateral Epicondylopathy

NCT07172568 | Recruiting

• 1 other identifier: 245/21 S-NP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Randomised controlled Trial; RCT; Interventional study; BFR; Blood-Flow-Restriction-Therapy; lateral Epicondylopathy; Epicondylitis

Outcome Measures

Primary Outcomes (16)

• Visual Analog Scale for pain

  VAS at rest and at dorsal extension of the hand. Measuring the pain on a scale from 1-10. 1 means no pain and 10 means extreme pain. The investigators are measuring the pain on the VAS scale once before and three times after the intervention within a time frame of 3 Months (directly after the intervention, 6 weeks after the intervention and 12 Weeks after the intervention). A higher score means a worse outcome, a lower score means a better outcome.

  3 months

• Mayo Elbow Performance Score

  The Mayo Elbow Performance Score (MEPS) is a clinical tool used to assess the function of the elbow joint, particularly in patients with elbow disorders or after treatment (e.g., surgery). It evaluates pain, range of motion, function, and elbow stability. Range of Scores: 0 to 100. 100 represents excellent elbow function with no pain. 75-89 is considered good, 60-74 is fair, and below 60 is poor. Scores are assessed before and three times after the intervention: Immediately post-intervention. 6 weeks post-intervention. 12 weeks post-intervention. This allows tracking of elbow recovery and functional improvement over time. A higher score indicates better recovery and elbow function.

  3 Months

• Short-form 36 questionnaire (SF-36)

  It is a questionnaire which is answered by the patients. The SF-36 (Short Form 36) Health Survey is a widely used questionnaire designed to assess an individual's overall health status. It measures eight domains of health: Physical Functioning Role Physical Role Emotional Mental Health Vitality (Energy/Fatigue) Social Functioning Pain General Health Each domain is scored on a scale from 0 to 100, with 0 representing the worst health status and 100 representing the best. The scores are then used to evaluate physical and mental health, as well as the impact of health on daily functioning. Range of Scores: 0-100 for each domain. Higher scores represent better health and functioning. Lower scores indicate greater impairment or worse health status. It helps in understanding an individual's quality of life and the impact of disease or disability on their physical and mental well-being. It is commonly used to evaluate patient health outcomes.

  3 Months

• Disabilities of the Arm, Shoulder and Hand questionnaire

  The DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire is a tool used to assess the physical function and symptoms in patients with musculoskeletal disorders of the upper limb. It evaluates function and pain in daily activities. Range of Scores: 0 to 100. 0 represents no disability (full function, no pain). 100 represents maximum disability (severe limitation and pain). The DASH score is typically measured before and three times after an intervention: Immediately post-intervention. 6 weeks post-intervention. 12 weeks post-intervention. Lower scores indicate better function and less disability, while higher scores show greater functional impairment and pain. The DASH helps to monitor recovery and the effectiveness of treatments for upper limb conditions.

  3 Months

• Patient rated tennis elbow evaluation questionnaire

  The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a questionnaire specifically designed to assess the severity of symptoms and the impact of lateral epicondylitis (tennis elbow) on a patient's daily life. It evaluates pain and function in the elbow, particularly in activities related to gripping and arm movement. Range of Scores: 0 to 100. 0 represents no pain or disability. 100 represents maximum pain or disability. The PRTEE is typically assessed before and three times after an intervention: Immediately post-intervention. 6 weeks post-intervention. 12 weeks post-intervention. Lower scores indicate less pain and disability, while higher scores suggest greater severity of symptoms. It is used to track the patient's progress and recovery from tennis elbow over time.

  3 Months

• clinical evaluation of the elbow

  clinical Evaluation including: Range of Motion

  3 Months

• Strength-Measurement: Dorsal extension of the hand

  Strength-Measurement: Dorsal extension of the hand using a dynamometer (MicroFET 2, Hoggan Scientific, Salt Lake City, USA). Measuring the affected elbow and the non-affected elbow

  3 Months

• Drop-Out

  statistical measurement of patients drop-out-quote using a Questionnaire about potential change to surgical Interventions or another type of therapy. statistical measurement of Lost to follow-up patients

  3 Months

• clinical examination of the elbow

  A clinical examination of the elbow is performed. The focus here is on the examination of possible instability in the elbow joint. To this end, valgus-axis stress is applied and the ability to open the joint is checked. The examination is assessed before and three times after an intervention: Foldability and instability indicate a poor outcome

  3 Months

• clinical evaluation of the elbow

  clinical evaluation of the elbow using Epicondylitis Tests (Cozen-Test)

  3 Months

• clinical evaluation of the elbow

  clinical evaluation of the elbow using Epicondylitis Tests (Reversed-Cozen-Test)

  3 Months

• clinical evaluation of the elbow

  clinical evaluation of the elbow using Epicondylitis Tests (Maudsley-Test)

  3 Months

• clinical examination of the elbow

  A clinical examination of the elbow is performed. The focus here is on the examination of possible instability in the elbow joint. To this end the milking maneuver is examined with possible medial opening. The examination is assessed before and three times after an intervention: Foldability and instability indicate a poor outcome

  3 Months

• clinical examination of the elbow

  A clinical examination of the elbow is performed. The focus here is on the examination of possible instability in the elbow joint. To this end the tweezer grip on the elbow are examined. The examination is assessed before and three times after an intervention: Foldability and instability indicate a poor outcome

  3 Months

• clinical examination of the elbow

  A clinical examination of the elbow is performed. The focus here is on the examination of possible instability in the elbow joint. To this end the pivot-shift test on the elbow is examined. The examination is assessed before and three times after an intervention: Foldability and instability indicate a poor outcome

  3 Months

• clinical examination of the elbow

  A clinical examination of the elbow is performed. The focus here is on the examination of possible instability in the elbow joint. To this end, varus-axis stress is applied and the ability to open the joint is checked. The examination is assessed before and three times after an intervention: Foldability and instability indicate a poor outcome

  3 months

Secondary Outcomes (4)

• Questionnaire

  3 Months

• Body mass index (BMI)

  3 Months

• Return-to-sports

  3 Months

• Return-to-work

  3 Months

Study Arms (2)

20mmHg pressure Blood Flow Restriction

ACTIVE COMPARATOR

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.

Procedure: sham-Blood Flow Restriction

50% of Mean arterial blood pressure Blood Flow Restriction

EXPERIMENTAL

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.

Procedure: Blood Flow Restriction

Interventions

Blood Flow Restriction PROCEDURE

In the intervention group, 50% of limb occlussion pressure are applied to the extremity during exercises.

50% of Mean arterial blood pressure Blood Flow Restriction

sham-Blood Flow Restriction PROCEDURE

In the control group, 20 mmHg are applied to the extremity during exercises.

20mmHg pressure Blood Flow Restriction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of Sports Orthopaedics, Technical University of Munich

Munich, Bavaria, 81675, Germany

RECRUITING

Related Publications (1)

• Hinz M, Franz A, Pirker C, Traimer S, Lappen S, Doucas A, Siebenlist S. [Blood flow restriction training as a treatment option for lateral elbow tendinopathy-a study presentation]. Orthopadie (Heidelb). 2023 May;52(5):365-370. doi: 10.1007/s00132-023-04370-w. Epub 2023 Apr 20. German.

  PMID: 37079041 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Elbow Tendinopathy; Tennis Elbow

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Maximilian Hinz, MD

  Department of Sports Orthopaedics, Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandros Doucas, MD

CONTACT

+491737442245; a.doucas@tum.de

Pavel Kadantsev, MD

CONTACT

+4915221021120; pavel.kadantsev@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Participant is randomly assigned to a cohort by drawing a number. Only the attending physiotherapist knows which number belongs to which cohort and start then either the BFR-training or the sham-BFR. The examining doctor in the preliminary investigation and in the follow-ups does not know how the patients were treated. Also the outcomes assessor has no informations about the treatment of the patients, therefore the assessment of the results is also carried out blindly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It's a Randomized Controlled Trial, double blinded. The participant and the investigator are blinded and have no information about the group affiliation.

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: September 15, 2025
• Study Start: August 25, 2021
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)