Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
70 participants
INTERVENTIONAL
2011-01-31
2011-09-30
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active control (Flexi-Bar only)
Flexi-Bar vibration training only over 12 weeks with three distinct exercises and 10min training twice daily
Flexi-Bar vibration device only
daily vibration training 10min twice
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)
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
Interventions
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Flexi-Bar vibration device only
daily vibration training 10min twice
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* informed consent
* ability to run at least 40-60min per week with a XCO-Trainer device
Exclusion Criteria
* no consent
* no ability to run at least 40-60min per week using a XCO-Trainer device
18 Years
65 Years
ALL
No
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Hannover Medical School, Plastic, Hand and Reconstructive Surgery
Principal Investigators
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Karsten Knobloch, FACS, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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Hannover Medical School, Plastic, Hand and Reconstructive Surgery
Hanover, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Knobloch K. [Non-operative therapy in lateral epicondylitis]. MMW Fortschr Med. 2009 Feb 19;151(8):28-30. No abstract available. German.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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VIBES-2010
Identifier Type: -
Identifier Source: org_study_id
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