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. 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
Information provided by:
Hannover Medical School

January 3, 2011
January 4, 2011
January 4, 2011
January 2011
September 2011   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
VIBration Training in EpicondylitiS
Vibration Training in Epicondylitis - a Randomized Trial

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 ( +/- the XCO-Trainer ( over twelve weeks.

The investigators sought to evaluate the clinical effects of either a vibration training using the Flexi-Bar vibration device ( +/- the XCO-Trainer ( 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).

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Epicondylitis
  • Pain
  • Tendinopathy
  • Device: Flexi-Bar vibration device only
    daily vibration training 10min twice
    Other Names:
    • vibration
    • Flexi bar
  • 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

    Other Names:
    • XCO
    • XCO Trainer
    • Flexibar
    • vibration
  • Active Comparator: Active control (Flexi-Bar only)
    Flexi-Bar vibration training only over 12 weeks with three distinct exercises and 10min training twice daily
    Intervention: Device: Flexi-Bar vibration device only
  • 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)
    Intervention: Device: Flexi-Bar + XCO-Trainer

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Hannover Medical School, Karsten Knobloch, MD, PHD, FACS, Hannover Medical School, Plastic, Hand and Reconstructive Surgery
Hannover Medical School
Not Provided
Principal Investigator: Karsten Knobloch, FACS, MD, PhD Hannover Medical School
Hannover Medical School
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP