VIBration Training in EpicondylitiS

Study Overview
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Brief Summary
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A number of different therapeutic approaches to treat lateral epicondylitis have been tested partly in randomized trials, such as polidocanol sclerosing injections, botulinom toxin A injections, braces, surgery and topical NO patches. One study indicates that patients with lateral epicondylitis (lateral elbow tendinopathy) have poorer elbow proprioception in contrast to healthy controls (Juul-Kristensen B, et al., J Shoulder Elbow Surg 2008;17(1 Suppl):72S-81S.) Based on a suggested poorer elbow proprioception in lateral elbow tendinopathy, The investigators hypothesize that a dedicated proprioceptive intervention might be able to reduce pain and improve function. As such a RCT is planned with two intervention arms with proprioceptive training using the Flexi-Bar vibration device (www.flexi-bar.co.uk) +/- the XCO-Trainer (www.xco-trainer.co.uk) over twelve weeks.

Detailed Description
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The investigators sought to evaluate the clinical effects of either a vibration training using the Flexi-Bar vibration device (www.flexi-bar.co.uk) +/- the XCO-Trainer (www.xco-trainer.co.uk) in a randomized trial among patients suffering lateral elbow tendinopathy (lateral epicondylitis). Primary outcome measure of this clinical trial is pain on a visual analogue scale (VAS 0-10) before and after 12 weeks of training. Secondary outcome parameters involve DASH score before and after, grip strength (JAMAR), vibration and two-point discrimination (mm).

Official Title
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Vibration Training in Epicondylitis - a Randomized Trial

Conditions
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Epicondylitis, Pain, Tendinopathy

Intervention / Treatment
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* Device: Flexi-Bar vibration device only
* Device: Flexi-Bar + XCO-Trainer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lateral elbow tendinopathy informed consent ability to run at least 40-60min per week with a XCO-Trainer device Exclusion Criteria: other sources of lateral elbow pain (joint instabilities, fractures) no consent no ability to run at least 40-60min per week using a XCO-Trainer device

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Active control (Flexi-Bar only)<br>Flexi-Bar vibration training only over 12 weeks with three distinct exercises and 10min training twice daily | Device: Flexi-Bar vibration device only<br>* daily vibration training 10min twice<br>* Other names: Flexi bar;|
| Experimental: Intervention Flexi-Bar + XCO-Trainer<br>Combination intervention using vibration device Flexi-Bar and XCO-Trainer (oscillating mass witin a tube moved during running 40-60min/week suggested) | Device: Flexi-Bar + XCO-Trainer<br>* XCO-Trainer is a way to overload the cardiovascular system and the core muscles during running. An oscillating mass inside the XCO-Trainer is activated when the XCO is propelled forward and backward with force. The movement of the mass triggers a series of responses from the runners' body. In addition Flexi-Bar vibration training as in the referred active comparator group<br>* Other names: vibration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on a visual analogue scale (VAS 0-10) | Pain on VAS (0=no pain at all, 10= worst pain imaginable) before and 12 weeks after the intervention. | before and 12 weeks after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASH Score | DASH score (0=no impairment, 100=severe impairment) of daily activities | before and 12 weeks after | 
| Grip strength (JAMAR) | Grip strength (JAMAR) in two elbow positions (0° flexion, 90° flexion) before and after 12 weeks of intervention | before and after 12 weeks | 
| Vibration | Vibration using a 128Hz tuning fork before and 12 weeks after the intervention | before and 12 weeks after | 
| 2-point discrimination | 2-point discrimination (mm) before and after the intervention and the finger tips | before and 12 weeks after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epicondylitis, pain, tendon