VIBration Training in EpicondylitiS (VIBES)

January 3, 2011 updated by: Hannover Medical School

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 (www.flexi-bar.co.uk) +/- the XCO-Trainer (www.xco-trainer.co.uk) over twelve weeks.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Hannover Medical School, Plastic, Hand and Reconstructive Surgery
        • Contact:
        • Principal Investigator:
          • Karsten Knobloch, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • vibration
  • XCO
  • XCO Trainer
  • Flexibar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before and 12 weeks after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH Score
Time Frame: before and 12 weeks after
DASH score (0=no impairment, 100=severe impairment) of daily activities
before and 12 weeks after
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
before and after 12 weeks
Vibration
Time Frame: before and 12 weeks after
Vibration using a 128Hz tuning fork before and 12 weeks after the intervention
before and 12 weeks after
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
before and 12 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Estimate)

January 4, 2011

Last Update Submitted That Met QC Criteria

January 3, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIBES-2010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Flexi-Bar vibration device only

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe