Clinical trial NCT01269879: VIBration Training in EpicondylitiS
Official title: Vibration Training in Epicondylitis - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Epicondylitis
Pain
Tendinopathy
Keywords: epicondylitis
pain
tendon
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Pain on a visual analogue scale (VAS 0-10)
timeFrame: before and 12 weeks after
Secondary outcomes:
measure: DASH Score
timeFrame: before and 12 weeks after
measure: Grip strength (JAMAR)
timeFrame: before and after 12 weeks
measure: Vibration
timeFrame: before and 12 weeks after
measure: 2-point discrimination
timeFrame: before and 12 weeks after the intervention
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Plastic, Hand and Reconstructive Surgery
Study officials:
affiliation: Hannover Medical School
name: Karsten Knobloch, FACS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Knobloch K. [Non-operative therapy in lateral epicondylitis]. MMW Fortschr Med. 2009 Feb 19;151(8):28-30. No abstract available. German.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.