VIBration Training in EpicondylitiS (VIBES)

H

Hannover Medical School (MHH)

Status and phase

Unknown
Phase 3

Conditions

Epicondylitis
Pain
Tendinopathy

Treatments

Device: Flexi-Bar vibration device only
Device: Flexi-Bar + XCO-Trainer

Study type

Interventional

Funder types

Other

Identifiers

NCT01269879
VIBES-2010

Details and patient eligibility

About

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.

Full 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).

Enrollment

70 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Active control (Flexi-Bar only)
Active Comparator group
Description:
Flexi-Bar vibration training only over 12 weeks with three distinct exercises and 10min training twice daily
Treatment:
Device: Flexi-Bar vibration device only
Intervention Flexi-Bar + XCO-Trainer
Experimental group
Description:
Combination intervention using vibration device Flexi-Bar and XCO-Trainer (oscillating mass witin a tube moved during running 40-60min/week suggested)
Treatment:
Device: Flexi-Bar + XCO-Trainer

Trial contacts and locations

0

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Central trial contact

Karsten Knobloch, FACS, MD, PhD

Data sourced from clinicaltrials.gov

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