VIBration Training in EpicondylitiS (VIBES)

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)

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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