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VIBES: VIBration Training in EpicondylitiS

Sponsor
Hannover Medical School (Other)
Overall Status
Unknown status
CT.gov ID
NCT01269879
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
8
Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Flexi-Bar vibration device only
  • Device: Flexi-Bar + XCO-Trainer
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vibration Training in Epicondylitis - a Randomized Trial
Study Start Date :
Jan 1, 2011
Anticipated Primary Completion Date :
Sep 1, 2011
Anticipated Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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
Other Names:
  • vibration
  • Flexi bar

    		•
    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
    Other Names:
  • XCO
  • XCO Trainer
  • Flexibar
  • vibration

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. DASH Score [before and 12 weeks after]

      DASH score (0=no impairment, 100=severe impairment) of daily activities

    2. 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

    3. Vibration [before and 12 weeks after]

      Vibration using a 128Hz tuning fork before and 12 weeks after the intervention

    4. 2-point discrimination [before and 12 weeks after the intervention]

      2-point discrimination (mm) before and after the intervention and the finger tips

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hannover Medical School, Plastic, Hand and Reconstructive Surgery Hannover Germany 30625

    Sponsors and Collaborators

    • Hannover Medical School

    Investigators

    • Principal Investigator: Karsten Knobloch, FACS, MD, PhD, Hannover Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01269879
    Other Study ID Numbers:
    • VIBES-2010
    First Posted:
    Jan 4, 2011
    Last Update Posted:
    Jan 4, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    epicondylitis
    pain
    tendon
    Additional relevant MeSH terms:
    Tendinopathy
    Tennis Elbow

    Study Results

    No Results Posted as of Jan 4, 2011