VIBration Training in EpicondylitiS (VIBES)
Recruitment status was Not yet recruiting
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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 |
- 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.
- 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:
|
|
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:
|
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 |
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| Contact: Karsten Knobloch, FACS, MD, PhD | +495115328864 | knobloch.karsten@mh-hannover.de |
| 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 | |
| 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:
|
Tennis Elbow Tendinopathy Musculoskeletal Diseases Arm Injuries |
Wounds and Injuries Muscular Diseases Tendon Injuries |
ClinicalTrials.gov processed this record on May 23, 2013