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Eccentric Training With or Without Elbow Brace for Epicondylitis (EpiFlex)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01273688
Recruitment Status : Unknown
Verified January 2011 by Hannover Medical School.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2011
Last Update Posted : January 10, 2011
Information provided by:
Hannover Medical School

Brief Summary:
Lateral epicondylitis is a painful overuse condition also described as lateral elbow tendinopathy. As at the Achilles tendon or the patella tendon, lateral elbow tendinopathy has striking clinically and histologically similarities. As such, neovascularisation closely related to pain-mediating fibers are encountered. Eccentric painful exercise is of clinical use in Achilles and patella tendinopathy. We sought to evaluate the clinical effect of a painful eccentric training (supination and pronation) with or without a orthopedic elbow brace in lateral epicondylitis.

Condition or disease Intervention/treatment Phase
Epicondylitis Tendinopathy Pain Behavioral: Eccentric training (Flex-Bar) Device: EpiHit elbow brace Phase 3

Detailed Description:

Two study arms are planned with both groups performed a home-based eccentric training using a Thera-Band Flex-Bar device. Supination and pronation are performed with each position on hold for 2s with 15 repetitions. This is repeated in three sets of 15 repetitions each twice daily. In other words, 6x15 repetitions of supination and pronation per day are suggested in the eccentric training using the Thera-Band Flex-Bar.

The combination group performs the same eccentric training. In addition, patients wear a orthopedic elbow brace (Epi-Hit) in order to overcome the elbow pain.

This is a clinical trial, thus pain reduction on a visual analogue scale is the primary outcome parameter. Evaluation will be performed after 12 weeks of intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Eccentric Training With Our Without Elbow Brace for Epicondylitis - a Randomized Clinical Trial
Study Start Date : February 2011
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Active Comparator: Eccentric training only
Eccentric training only active control group (Flex-Bar)
Behavioral: Eccentric training (Flex-Bar)
6x15 repetitions of supination and pronation daily over 12 weeks

Experimental: Eccentric training and elbow brace
Combined eccentric training (Flex-Bar) and elbow brace (Epi-Hit)
Behavioral: Eccentric training (Flex-Bar)
6x15 repetitions of supination and pronation daily over 12 weeks

Device: EpiHit elbow brace
daily wearing of the EpiHit elbow brace
Other Names:
  • brace
  • orthosis
  • strap

Primary Outcome Measures :
  1. Pain on visual analogue scale (VAS 0-10) [ Time Frame: 12 weeks ]
    Pain on VAS (0=no pain, 10=worst pain)

Secondary Outcome Measures :
  1. Grip strength (JAMAR) [ Time Frame: 12 weeks ]
    Grip strength (JAMAR, kg) in two elbow positions: 0° flexion and 90° flexion

  2. Elbow microcirculation [ Time Frame: 12 weeks ]
    Oxygen-to-see combined Laser-Doppler flowmetry and spektrophotometry system non-invasively analyzing three parameters: tissue oxygen saturation, capillary blood flow, postcapillary venous filling pressure

  3. DASH Score [0-100] [ Time Frame: 12 weeks ]
    DASH score [0=no impairment of daily activities, 100= severe impairment) before and 12 weeks after intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • lateral elbow tendinopathy
  • 18-80 years informed consent

Exclusion Criteria:

  • no elbow tendinopathy <18 or > 80 years no informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01273688

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Contact: Karsten Knobloch, FACS, MD, PhD +495115328864

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Hannover Medical School
Hannover, Germany, 30625
Contact: Karsten Knobloch, FACS, MD, PhD, FACS   
Sponsors and Collaborators
Hannover Medical School
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Principal Investigator: Karsten Knobloch, FACS, MD, PhD Hannover Medical School, Germany

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Responsible Party: Hannover Medical School, Karsten Knobloch, FACS, MD, PhD, Hannover Medical School, Plastic, Hand and Reconstructive Surgery Identifier: NCT01273688    
Other Study ID Numbers: EpiFlex
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: January 2011
Keywords provided by Hannover Medical School:
Additional relevant MeSH terms:
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Tennis Elbow
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Elbow Tendinopathy
Arm Injuries