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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Hannover Medical School

Study Description
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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.


Study Design
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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
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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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


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

Inclusion Criteria:

  • lateral elbow tendinopathy
  • 18-80 years informed consent

Exclusion Criteria:

  • no elbow tendinopathy <18 or > 80 years no informed consent
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01273688


Contacts
Contact: Karsten Knobloch, FACS, MD, PhD +495115328864 knobloch.karsten@mh-hannover.de

Locations
Germany
Hannover Medical School Not yet recruiting
Hannover, Germany, 30625
Contact: Karsten Knobloch, FACS, MD, PhD, FACS       knobloch.karsten@mh-hannover.de   
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Karsten Knobloch, FACS, MD, PhD Hannover Medical School, Germany
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Hannover Medical School, Karsten Knobloch, FACS, MD, PhD, Hannover Medical School, Plastic, Hand and Reconstructive Surgery
ClinicalTrials.gov Identifier: NCT01273688     History of Changes
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:
pain
elbow
tendinopathy

Additional relevant MeSH terms:
Tendinopathy
Tennis Elbow
Muscular Diseases
Musculoskeletal Diseases
 Tendon Injuries
Wounds and Injuries
Elbow Tendinopathy
Arm Injuries