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EpicondylitisPhase 3VIBESNCT01269879

VIBration Training in EpicondylitiS

A Phase 3 study testing Flexi-Bar vibration device only and Flexi-Bar + XCO-Trainer in people with Epicondylitis and Pain, run by Hannover Medical School at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Epicondylitis, Pain, Tendinopathy
What is being tested?
Flexi-Bar vibration device only and Flexi-Bar + XCO-Trainer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteGermany
Study dates
Jan 2011to Sep 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • lateral elbow tendinopathy
  • informed consent
  • ability to run at least 40-60min per week with a XCO-Trainer device

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Karsten Knobloch, FACS, MD, PhD contact

+495115328864

knobloch.karsten@mh-hannover.de

Germany1 site

  • Hannover Medical School, Plastic, Hand and Reconstructive Surgery

    Hanover, 30625

    Karsten Knobloch, MD, PhD, FACS, +495115328864, knobloch.karsten@mh-hannover.de

    Karsten Knobloch, MD, PhD

Other trials in Germany

About this study

Official title: 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.)

Read more

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.

Read the 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).

Being tested
Flexi-Bar vibration device only, Flexi-Bar + XCO-Trainer
Keywords
epicondylitis, pain, tendon
Medical subject headings
Pain, Tendinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flexi-Bar vibration device onlyDevice

    Also called vibration, Flexi bar

    daily vibration training 10min twice

  • Flexi-Bar + XCO-TrainerDevice

    Also called XCO, XCO Trainer, Flexibar, vibration

    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

Study groups in NCT01269879
Study groupRoleWhat they receive
Active control (Flexi-Bar only)Active comparatorFlexi-Bar vibration training only over 12 weeks with three distinct exercises and 10min training twice daily
Receives: Device: Flexi-Bar vibration device only
Intervention Flexi-Bar + XCO-TrainerExperimentalCombination intervention using vibration device Flexi-Bar and XCO-Trainer (oscillating mass witin a tube moved during running 40-60min/week suggested)
Receives: Device: Flexi-Bar + XCO-Trainer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain on a visual analogue scale (VAS 0-10)

    Pain on VAS (0=no pain at all, 10= worst pain imaginable) before and 12 weeks after the intervention.

    Measured: before and 12 weeks after

Secondary outcomes (4)

  1. DASH Score

    DASH score (0=no impairment, 100=severe impairment) of daily activities

    Measured: before and 12 weeks after

  2. Grip strength (JAMAR)

    Grip strength (JAMAR) in two elbow positions (0° flexion, 90° flexion) before and after 12 weeks of intervention

    Measured: before and after 12 weeks

  3. Vibration

    Vibration using a 128Hz tuning fork before and 12 weeks after the intervention

    Measured: before and 12 weeks after

  4. 2-point discrimination

    2-point discrimination (mm) before and after the intervention and the finger tips

    Measured: before and 12 weeks after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionSep 2011 (estimated)
  4. Study completionSep 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01269879
Sponsor's protocol ID
VIBES-2010
Acronym
VIBES
Status last verified
Jan 2011
First submitted
3 Jan 2011
Last updated
4 Jan 2011
Results posted
No
Data monitoring committee
No

Publications

  • Knobloch K. Lateral elbow tendinopathy. Am J Sports Med. 2010 Nov;38(11):NP3; author reply NP3-4. doi: 10.1177/0363546510383492. No abstract available.

    PubMed 20971969

  • Knobloch K. [Non-operative therapy in lateral epicondylitis]. MMW Fortschr Med. 2009 Feb 19;151(8):28-30. No abstract available. German.

    PubMed 19432271

  • Knobloch K. Re: Radiofrequency microtenotomy: a promising method for treatment of recalcitrant lateral epicondylitis. Am J Sports Med. 2008 Nov;36(11):e2-3; author reply e3. doi: 10.1177/0363546508325661. No abstract available.

    PubMed 18978181

  • Knobloch K, Spies M, Busch KH, Vogt PM. Sclerosing therapy and eccentric training in flexor carpi radialis tendinopathy in a tennis player. Br J Sports Med. 2007 Dec;41(12):920-1. doi: 10.1136/bjsm.2007.036558. Epub 2007 May 11.

    PubMed 17496066

  • Knobloch K. [Eccentric exercise in tendinopathies]. Sportverletz Sportschaden. 2010 Dec;24(4):187. doi: 10.1055/s-0029-1245845. Epub 2010 Dec 14. No abstract available. German.

    PubMed 21157652

  • Knobloch K, Gohritz A. Dr Runge: a German pioneer in sclerosing therapy in epicondylitis in 1873. Br J Sports Med. 2010 Nov 16. doi: 10.1136/bjsm.2008.051326. Online ahead of print. No abstract available.

    PubMed 21081643

  • Yoon U, Knobloch K. Reporting quality in evidence-based studies. J Am Coll Surg. 2010 Apr;210(4):533. doi: 10.1016/j.jamcollsurg.2009.12.028. No abstract available.

    PubMed 20347748

  • Yoon U, Knobloch K. Quality of reporting in sports injury prevention abstracts according to the CONSORT and STROBE criteria: an analysis of the World Congress of Sports Injury Prevention in 2005 and 2008. Br J Sports Med. 2012 Mar;46(3):202-6. doi: 10.1136/bjsm.2008.053876. Epub 2009 Jul 26.

    PubMed 19656768

  • Juul-Kristensen B, Lund H, Hansen K, Christensen H, Danneskiold-Samsoe B, Bliddal H. Poorer elbow proprioception in patients with lateral epicondylitis than in healthy controls: a cross-sectional study. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1 Suppl):72S-81S. doi: 10.1016/j.jse.2007.07.003. Epub 2007 Nov 26.

    PubMed 18036844

  • Garg R, Adamson GJ, Dawson PA, Shankwiler JA, Pink MM. A prospective randomized study comparing a forearm strap brace versus a wrist splint for the treatment of lateral epicondylitis. J Shoulder Elbow Surg. 2010 Jun;19(4):508-12. doi: 10.1016/j.jse.2009.12.015. Epub 2010 Apr 2.

    PubMed 20363158

  • Mileva KN, Kadr M, Amin N, Bowtell JL. Acute effects of Flexi-bar vs. Sham-bar exercise on muscle electromyography activity and performance. J Strength Cond Res. 2010 Mar;24(3):737-48. doi: 10.1519/JSC.0b013e3181c7c2d8.

    PubMed 20145560

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Flexi-Bar vibration device only and Flexi-Bar + XCO-Trainer in people with Epicondylitis and Pain, run by Hannover Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Karsten Knobloch, FACS, MD, PhD (+495115328864, knobloch.karsten@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain on a visual analogue scale (VAS 0-10) (time frame: before and 12 weeks after). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01269879, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2011.

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