VIBration Training in EpicondylitiS (VIBES)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Hannover Medical School.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01269879
First received: January 3, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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 Intervention Phase
Epicondylitis
Pain
Tendinopathy
Device: Flexi-Bar vibration device only
Device: Flexi-Bar + XCO-Trainer
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vibration Training in Epicondylitis - a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Pain on a visual analogue scale (VAS 0-10) [ Time Frame: before and 12 weeks after ] [ Designated as safety issue: Yes ]
    Pain on VAS (0=no pain at all, 10= worst pain imaginable) before and 12 weeks after the intervention.


Secondary Outcome Measures:
  • DASH Score [ Time Frame: before and 12 weeks after ] [ Designated as safety issue: Yes ]
    DASH score (0=no impairment, 100=severe impairment) of daily activities

  • Grip strength (JAMAR) [ Time Frame: before and after 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    2-point discrimination (mm) before and after the intervention and the finger tips


Estimated Enrollment: 70
Study Start Date: January 2011
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269879

Contacts
Contact: Karsten Knobloch, FACS, MD, PhD +495115328864 knobloch.karsten@mh-hannover.de

Locations
Germany
Hannover Medical School, Plastic, Hand and Reconstructive Surgery Not yet recruiting
Hannover, Germany, 30625
Contact: Karsten Knobloch, MD, PhD, FACS    +495115328864    knobloch.karsten@mh-hannover.de   
Principal Investigator: Karsten Knobloch, MD, PhD         
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Karsten Knobloch, FACS, MD, PhD Hannover Medical School
  More Information

Publications:

Responsible Party: Hannover Medical School, Karsten Knobloch, MD, PHD, FACS, Hannover Medical School, Plastic, Hand and Reconstructive Surgery
ClinicalTrials.gov Identifier: NCT01269879     History of Changes
Other Study ID Numbers: VIBES-2010
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
epicondylitis
pain
tendon

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014