VIBration Training in EpicondylitiS (VIBES)
|ClinicalTrials.gov Identifier: NCT01269879|
Recruitment Status : Unknown
Verified January 2011 by Hannover Medical School.
Recruitment status was: Not yet recruiting
First Posted : January 4, 2011
Last Update Posted : January 4, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Epicondylitis Pain Tendinopathy||Device: Flexi-Bar vibration device only Device: Flexi-Bar + XCO-Trainer||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vibration Training in Epicondylitis - a Randomized Trial|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||September 2011|
Active Comparator: Active control (Flexi-Bar only)
Flexi-Bar vibration training only over 12 weeks with three distinct exercises and 10min training twice daily
Device: Flexi-Bar vibration device only
daily vibration training 10min twice
Experimental: Intervention 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)
Device: Flexi-Bar + XCO-Trainer
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
- Pain on a visual analogue scale (VAS 0-10) [ Time Frame: before and 12 weeks after ]Pain on VAS (0=no pain at all, 10= worst pain imaginable) before and 12 weeks after the intervention.
- DASH Score [ Time Frame: before and 12 weeks after ]DASH score (0=no impairment, 100=severe impairment) of daily activities
- Grip strength (JAMAR) [ Time Frame: before and after 12 weeks ]Grip strength (JAMAR) in two elbow positions (0° flexion, 90° flexion) before and after 12 weeks of intervention
- Vibration [ Time Frame: before and 12 weeks after ]Vibration using a 128Hz tuning fork before and 12 weeks after the intervention
- 2-point discrimination [ Time Frame: before and 12 weeks after the intervention ]2-point discrimination (mm) before and after the intervention and the finger tips
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269879
|Contact: Karsten Knobloch, FACS, MD, PhDemail@example.com|
|Hannover Medical School, Plastic, Hand and Reconstructive Surgery||Not yet recruiting|
|Hannover, Germany, 30625|
|Contact: Karsten Knobloch, MD, PhD, FACS +495115328864 firstname.lastname@example.org|
|Principal Investigator: Karsten Knobloch, MD, PhD|
|Principal Investigator:||Karsten Knobloch, FACS, MD, PhD||Hannover Medical School|