Pain Clinical Trial
— VIBESOfficial 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.)
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.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Hannover Medical School, Plastic, Hand and Reconstructive Surgery | Hannover |
Lead Sponsor | Collaborator |
---|---|
Hannover Medical School |
Germany,
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. — View Citation
Juul-Kristensen B, Lund H, Hansen K, Christensen H, Danneskiold-Samsøe 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. Epub 2007 Nov 26. — View Citation
Knobloch K, Gohritz A. Dr Runge: a German pioneer in sclerosing therapy in epicondylitis in 1873. Br J Sports Med. 2010 Nov 16. [Epub ahead of print] — View 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. Epub 2007 May 11. — View Citation
Knobloch K. [Eccentric exercise in tendinopathies]. Sportverletz Sportschaden. 2010 Dec;24(4):187. doi: 10.1055/s-0029-1245845. Epub 2010 Dec 14. German. — View Citation
Knobloch K. [Non-operative therapy in lateral epicondylitis]. MMW Fortschr Med. 2009 Feb 19;151(8):28-30. German. — View Citation
Knobloch K. Lateral elbow tendinopathy. Am J Sports Med. 2010 Nov;38(11):NP3; author reply NP3-4. doi: 10.1177/0363546510383492. — View 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. — View 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. — View 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. — View 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | before and 12 weeks after | Yes |
Secondary | DASH Score | DASH score (0=no impairment, 100=severe impairment) of daily activities | before and 12 weeks after | Yes |
Secondary | Grip strength (JAMAR) | Grip strength (JAMAR) in two elbow positions (0° flexion, 90° flexion) before and after 12 weeks of intervention | before and after 12 weeks | No |
Secondary | Vibration | Vibration using a 128Hz tuning fork before and 12 weeks after the intervention | before and 12 weeks after | No |
Secondary | 2-point discrimination | 2-point discrimination (mm) before and after the intervention and the finger tips | before and 12 weeks after the intervention | No |
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