VIBration Training in EpicondylitiS

Phase 3

• Conditions: Epicondylitis; Pain; Tendinopathy
• Interventions: Device: Flexi-Bar + XCO-Trainer; Device: Flexi-Bar vibration device only

• Registration Number: NCT01269879
• Lead Sponsor: Hannover Medical School

Brief Summary

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

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).

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Last Update Submitted: 2011-01-03
• Study First Posted: 2011-01-04
• Last Update Posted: 2011-01-04
• Primary Completion: 2011-09
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Flexi-Bar + XCO-Trainer	Flexi-Bar + XCO-Trainer	Combination intervention using vibration device Flexi-Bar and XCO-Trainer (oscillating mass witin a tube moved during running 40-60min/week suggested)
Active control (Flexi-Bar only)	Flexi-Bar vibration device only	Flexi-Bar vibration training only over 12 weeks with three distinct exercises and 10min training twice daily

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hannover Medical School, Plastic, Hand and Reconstructive Surgery; 🇩🇪 Hannover, Germany