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Clinical Trials/NCT01269879
NCT01269879
Unknown
Phase 3

Vibration Training in Epicondylitis - a Randomized Trial

Hannover Medical School1 site in 1 country70 target enrollmentJanuary 2011

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Epicondylitis
Sponsor
Hannover Medical School
Enrollment
70
Locations
1
Primary Endpoint
Pain on a visual analogue scale (VAS 0-10)
Last Updated
15 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
September 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • DASH Score(before and 12 weeks after)
  • Grip strength (JAMAR)(before and after 12 weeks)
  • Vibration(before and 12 weeks after)
  • 2-point discrimination(before and 12 weeks after the intervention)

Study Sites (1)

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