VIBration Training in EpicondylitiS (VIBES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|