Blood Flow Restriction Training For The Treatment Of Lateral Epicondylopathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTechnical University of Munich

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosis of lateral epicondylitis

duration of symptoms > 6 weeks

failed physical therapy

absence of x-ray abnormalities

Disqualifiers

prior joint infiltrations

duration of symptoms > 12 months

concomitant rheumatoid diseases

concomitant elbow pathologies, including medial epicondylitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood Flow Restriction

    Procedure/Surgery

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

  • sham-Blood Flow Restriction

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: 20mmHg pressure Blood Flow RestrictionActive comparator 1 intervention
Group B: 50% of Mean arterial blood pressure Blood Flow RestrictionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
3 Months
3

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.

Time frame
3 Months
4

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.

Time frame
3 Months

Secondary outcomes

1

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.

Time frame
3 Months
2

Body mass index (BMI)

measuring secondary objective as a potential confounder

Time frame
3 Months
3

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.

Time frame
3 Months
4

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.

Time frame
3 Months

Other outcomes

Sponsors and contacts

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