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VIBration Training in EpicondylitiS (VIBES)

Primary Purpose

Epicondylitis, Pain, Tendinopathy

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Flexi-Bar vibration device only
Flexi-Bar + XCO-Trainer
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epicondylitis focused on measuring epicondylitis, pain, tendon

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hannover Medical School, Plastic, Hand and Reconstructive Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Active control (Flexi-Bar only)

Intervention Flexi-Bar + XCO-Trainer

Arm Description

Flexi-Bar vibration training only over 12 weeks with three distinct exercises and 10min training twice daily

Combination intervention using vibration device Flexi-Bar and XCO-Trainer (oscillating mass witin a tube moved during running 40-60min/week suggested)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

DASH Score
DASH score (0=no impairment, 100=severe impairment) of daily activities
Grip strength (JAMAR)
Grip strength (JAMAR) in two elbow positions (0° flexion, 90° flexion) before and after 12 weeks of intervention
Vibration
Vibration using a 128Hz tuning fork before and 12 weeks after the intervention
2-point discrimination
2-point discrimination (mm) before and after the intervention and the finger tips

Full Information

First Posted
January 3, 2011
Last Updated
January 3, 2011
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01269879
Brief Title
VIBration Training in EpicondylitiS
Acronym
VIBES
Official Title
Vibration Training in Epicondylitis - a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hannover Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis, Pain, Tendinopathy
Keywords
epicondylitis, pain, tendon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active control (Flexi-Bar only)
Arm Type
Active Comparator
Arm Description
Flexi-Bar vibration training only over 12 weeks with three distinct exercises and 10min training twice daily
Arm Title
Intervention Flexi-Bar + XCO-Trainer
Arm Type
Experimental
Arm Description
Combination intervention using vibration device Flexi-Bar and XCO-Trainer (oscillating mass witin a tube moved during running 40-60min/week suggested)
Intervention Type
Device
Intervention Name(s)
Flexi-Bar vibration device only
Other Intervention Name(s)
vibration, Flexi bar
Intervention Description
daily vibration training 10min twice
Intervention Type
Device
Intervention Name(s)
Flexi-Bar + XCO-Trainer
Other Intervention Name(s)
XCO, XCO Trainer, Flexibar, vibration
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain on a visual analogue scale (VAS 0-10)
Description
Pain on VAS (0=no pain at all, 10= worst pain imaginable) before and 12 weeks after the intervention.
Time Frame
before and 12 weeks after
Secondary Outcome Measure Information:
Title
DASH Score
Description
DASH score (0=no impairment, 100=severe impairment) of daily activities
Time Frame
before and 12 weeks after
Title
Grip strength (JAMAR)
Description
Grip strength (JAMAR) in two elbow positions (0° flexion, 90° flexion) before and after 12 weeks of intervention
Time Frame
before and after 12 weeks
Title
Vibration
Description
Vibration using a 128Hz tuning fork before and 12 weeks after the intervention
Time Frame
before and 12 weeks after
Title
2-point discrimination
Description
2-point discrimination (mm) before and after the intervention and the finger tips
Time Frame
before and 12 weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karsten Knobloch, FACS, MD, PhD
Phone
+495115328864
Email
knobloch.karsten@mh-hannover.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Knobloch, FACS, MD, PhD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover Medical School, Plastic, Hand and Reconstructive Surgery
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karsten Knobloch, MD, PhD, FACS
Phone
+495115328864
Email
knobloch.karsten@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Karsten Knobloch, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20971969
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.
Results Reference
background
PubMed Identifier
19432271
Citation
Knobloch K. [Non-operative therapy in lateral epicondylitis]. MMW Fortschr Med. 2009 Feb 19;151(8):28-30. No abstract available. German.
Results Reference
background
PubMed Identifier
18978181
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.
Results Reference
background
PubMed Identifier
17496066
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.
Results Reference
background
PubMed Identifier
21157652
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.
Results Reference
background
PubMed Identifier
21081643
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.
Results Reference
background
PubMed Identifier
20347748
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.
Results Reference
background
PubMed Identifier
19656768
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.
Results Reference
background
PubMed Identifier
18036844
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.
Results Reference
background
PubMed Identifier
20363158
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.
Results Reference
background
PubMed Identifier
20145560
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.
Results Reference
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VIBration Training in EpicondylitiS

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