Eccentric Training With or Without Elbow Brace for Epicondylitis

Study Overview
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Brief Summary
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Lateral epicondylitis is a painful overuse condition also described as lateral elbow tendinopathy. As at the Achilles tendon or the patella tendon, lateral elbow tendinopathy has striking clinically and histologically similarities. As such, neovascularisation closely related to pain-mediating fibers are encountered. Eccentric painful exercise is of clinical use in Achilles and patella tendinopathy. We sought to evaluate the clinical effect of a painful eccentric training (supination and pronation) with or without a orthopedic elbow brace in lateral epicondylitis.

Detailed Description
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Two study arms are planned with both groups performed a home-based eccentric training using a Thera-Band Flex-Bar device. Supination and pronation are performed with each position on hold for 2s with 15 repetitions. This is repeated in three sets of 15 repetitions each twice daily. In other words, 6x15 repetitions of supination and pronation per day are suggested in the eccentric training using the Thera-Band Flex-Bar. The combination group performs the same eccentric training. In addition, patients wear a orthopedic elbow brace (Epi-Hit) in order to overcome the elbow pain. This is a clinical trial, thus pain reduction on a visual analogue scale is the primary outcome parameter. Evaluation will be performed after 12 weeks of intervention.

Official Title
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Eccentric Training With Our Without Elbow Brace for Epicondylitis - a Randomized Clinical Trial

Conditions
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Epicondylitis, Tendinopathy, Pain

Intervention / Treatment
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* Behavioral: Eccentric training (Flex-Bar)
* Device: EpiHit elbow brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lateral elbow tendinopathy 18-80 years informed consent Exclusion Criteria: no elbow tendinopathy <18 or > 80 years no informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eccentric training only<br>Eccentric training only active control group (Flex-Bar) | Behavioral: Eccentric training (Flex-Bar)<br>* 6x15 repetitions of supination and pronation daily over 12 weeks<br>|
| Experimental: Eccentric training and elbow brace<br>Combined eccentric training (Flex-Bar) and elbow brace (Epi-Hit) | Behavioral: Eccentric training (Flex-Bar)<br>* 6x15 repetitions of supination and pronation daily over 12 weeks<br>Device: EpiHit elbow brace<br>* daily wearing of the EpiHit elbow brace<br>* Other names: strap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on visual analogue scale (VAS 0-10) | Pain on VAS (0=no pain, 10=worst pain) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength (JAMAR) | Grip strength (JAMAR, kg) in two elbow positions: 0° flexion and 90° flexion | 12 weeks | 
| Elbow microcirculation | Oxygen-to-see combined Laser-Doppler flowmetry and spektrophotometry system non-invasively analyzing three parameters: tissue oxygen saturation, capillary blood flow, postcapillary venous filling pressure | 12 weeks | 
| DASH Score [0-100] | DASH score [0=no impairment of daily activities, 100= severe impairment) before and 12 weeks after intervention | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, elbow, tendinopathy