Elbow TendinopathyEPIC-BFRNCT07172568
Blood Flow Restriction Training For The Treatment Of Lateral Epicondylopathy
A study testing Blood Flow Restriction in people with Elbow Tendinopathy and Elbow, Tennis, run by Technical University of Munich at 1 site in Germany.
Trial summary
The study aims to evaluate the effectiveness of Blood Flow Restriction Training for the treatment of lateral elbow epicondylopathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Elbow Tendinopathy, Elbow, Tennis, Lateral Epicondylitis
- What is being tested?
- Blood Flow Restriction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 25 Aug 2021to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of lateral epicondylitis
- duration of symptoms > 6 weeks
- failed physical therapy
- absence of x-ray abnormalities
- written and informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Sports Orthopaedics, Technical University of Munich
Munich, Bavaria, 81675
Maximilian Hinz, MD, maximilian.hinz@tum.de
About this study
Official title: Randomisierte, Kontrollierte Untersuchung Der Wirksamkeit Von Blood Flow Restriction (BFR)-Training Zur Behandlung Der Epicondylopathia Humeri Radialis
The study aims to evaluate the effectiveness of Blood Flow Restriction Training for the treatment of lateral elbow epicondylopathy.
Read the detailed description
- 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.
- 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.
- Conditions
- Elbow Tendinopathy, Elbow, Tennis, Lateral Epicondylitis, Epicondylitis of the Elbow, Blood Flow Restriction Therapy, BFR
- Being tested
- Blood Flow Restriction, sham-Blood Flow Restriction
- Keywords
- Randomised controlled Trial, RCT, Interventional study, BFR, Blood-Flow-Restriction-Therapy, lateral Epicondylopathy, Epicondylitis
- Medical subject headings
- Elbow Tendinopathy, Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionProcedure or surgery
In the intervention group, 50% of limb occlussion pressure are applied to the extremity during exercises.
sham-Blood Flow RestrictionProcedure or surgery
In the control group, 20 mmHg are applied to the extremity during exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 Months
clinical evaluation of the elbow
clinical Evaluation including: Range of Motion
Measured: 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
Measured: 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
Measured: 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
Measured: 3 Months
clinical evaluation of the elbow
clinical evaluation of the elbow using Epicondylitis Tests (Cozen-Test)
Measured: 3 Months
clinical evaluation of the elbow
clinical evaluation of the elbow using Epicondylitis Tests (Reversed-Cozen-Test)
Measured: 3 Months
clinical evaluation of the elbow
clinical evaluation of the elbow using Epicondylitis Tests (Maudsley-Test)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Secondary outcomes (4)
Questionnaire
The questionnaire the investigators created, also contains individual questions that ask about possible confounders. These are questions about gender
- Age
- Nicotine abuse
- Type of sport, activity level/intensity, frequency with these questions the investigators would like to identify possible confounders.
Measured: 3 Months
Body mass index (BMI)
measuring secondary objective as a potential confounder
Measured: 3 Months
Return-to-sports
The Return to Sports Rate is a measure used to assess the percentage of individuals who return to their pre-injury or pre-intervention level of sports activity following treatment or rehabilitation. It provides insight into how effectively a patient has recovered and whether they can resume their sports participation at a similar level to before the injury.
In this case, the investigators use a questionnaire to gather information about the type of sport, frequency, and weekly time commitment to sports activities.
By comparing the responses from these time points, the investigators can calculate the Return to Sports Rate. This rate is determined by assessing how many participants have returned to their previous levels of sports activity, or how close they are to their baseline sports participation after the intervention.
Measured: 3 Months
Return-to-work
The Return to Work Rate is a measure used to assess the percentage of individuals who are able to return to their pre-injury or pre-intervention work activities following treatment or rehabilitation. It helps to evaluate the effectiveness of the intervention in enabling patients to resume their work duties. In this case, the investigators use a questionnaire to gather information about the type of work, work frequency, and the time commitment per week spent on work activities.
By comparing the responses from these time points, the investigators can calculate the Return to Work Rate. This rate is determined by assessing how many participants have returned to their previous work activities or how close they are to their baseline work participation after the intervention.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start25 Aug 2021
- Primary completion31 Dec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elbow TendinopathyStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Model description
- It's a Randomized Controlled Trial, double blinded. The participant and the investigator are blinded and have no information about the group affiliation.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maximilian Hinz, MD, Principal investigator, Department of Sports Orthopaedics, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172568
- Sponsor's protocol ID
- 245/21 S-NP
- Acronym
- EPIC-BFR
- Status last verified
- Sep 2025
- First submitted
- 13 Feb 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not shared due to strict data protection laws in Germany, such as the GDPR, which ensure the security of sensitive medical data. Sharing individual patient data poses significant risks to data security, particularly regarding unauthorized access or misuse. Additionally, explicit consent from participants is often missing for data sharing beyond the original research purpose. Without such consent, any disclosure would be legally impermissible and ethically problematic. Therefore, safeguarding privacy and complying with legal regulations are paramount.
Publications
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.
PubMed 37079041
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomisierte, Kontrollierte Untersuchung Der Wirksamkeit Von Blood Flow Restriction (BFR)-Training Zur Behandlung Der Epicondylopathia Humeri Radialis
- ClinicalTrials.gov ID
- NCT07172568
- Acronym / sponsor ID
- EPIC-BFR / 245/21 S-NP
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 15 Sep 2025 (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.
The study aims to evaluate the effectiveness of Blood Flow Restriction Training for the treatment of lateral elbow epicondylopathy.
Detailed description
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- It's a Randomized Controlled Trial, double blinded. The participant and the investigator are blinded and have no information about the group affiliation.
| Arm | Type | Receives |
|---|---|---|
| 20mmHg pressure Blood Flow Restriction | Active comparator | Procedure: sham-Blood Flow RestrictionThe 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. |
| 50% of Mean arterial blood pressure Blood Flow Restriction | Experimental | Procedure: Blood Flow RestrictionThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of lateral epicondylitis
- duration of symptoms > 6 weeks
- failed physical therapy
- absence of x-ray abnormalities
- written and informed consent
Key exclusion criteria (6 listed)
- 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
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 RestrictionIn the intervention group, 50% of limb occlussion pressure are applied to the extremity during exercises. | Procedure or surgery | 50% of Mean arterial blood pressure Blood Flow Restriction |
| sham-Blood Flow RestrictionIn the control group, 20 mmHg are applied to the extremity during exercises. | Procedure or surgery | 20mmHg pressure Blood Flow Restriction |
Primary outcome
Visual Analog Scale for pain
Time frame: 3 months
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.
Mayo Elbow Performance Score
Time frame: 3 Months
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.
Short-form 36 questionnaire (SF-36)
Time frame: 3 Months
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.
Disabilities of the Arm, Shoulder and Hand questionnaire
Time frame: 3 Months
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.
Patient rated tennis elbow evaluation questionnaire
Time frame: 3 Months
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.
clinical evaluation of the elbow
Time frame: 3 Months
clinical Evaluation including: Range of Motion
Strength-Measurement: Dorsal extension of the hand
Time frame: 3 Months
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
Drop-Out
Time frame: 3 Months
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
clinical examination of the elbow
Time frame: 3 Months
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
clinical evaluation of the elbow
Time frame: 3 Months
clinical evaluation of the elbow using Epicondylitis Tests (Cozen-Test)
clinical evaluation of the elbow
Time frame: 3 Months
clinical evaluation of the elbow using Epicondylitis Tests (Reversed-Cozen-Test)
clinical evaluation of the elbow
Time frame: 3 Months
clinical evaluation of the elbow using Epicondylitis Tests (Maudsley-Test)
clinical examination of the elbow
Time frame: 3 Months
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
clinical examination of the elbow
Time frame: 3 Months
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
clinical examination of the elbow
Time frame: 3 Months
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
clinical examination of the elbow
Time frame: 3 months
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
4 secondary outcomes
Questionnaire
Time frame: 3 Months
Body mass index (BMI)
Time frame: 3 Months
Return-to-sports
Time frame: 3 Months
Return-to-work
Time frame: 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 37079041Hinz 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD is not shared due to strict data protection laws in Germany, such as the GDPR, which ensure the security of sensitive medical data. Sharing individual patient data poses significant risks to data security, particularly regarding unauthorized access or misuse. Additionally, explicit consent from participants is often missing for data sharing beyond the original research purpose. Without such consent, any disclosure would be legally impermissible and ethically problematic. Therefore, safeguarding privacy and complying with legal regulations are paramount.
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Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
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.
Maximilian Hinz, MD principal investigator
Department of Sports Orthopaedics, Technical University of Munich
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 in people with Elbow Tendinopathy and Elbow, Tennis, run by Technical University of Munich at 1 site in Germany.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandros Doucas, MD (+491737442245, a.doucas@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for pain (time frame: 3 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07172568, which also lists 1 linked publication.
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 15 Sep 2025.