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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Hannover Medical School.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01273688
First received: January 3, 2011
Last updated: January 7, 2011
Last verified: January 2011
History of Changes
  Purpose
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 Intervention Phase
Epicondylitis
Tendinopathy
Pain
 Behavioral: Eccentric training (Flex-Bar)
Device: EpiHit elbow brace
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Eccentric Training With Our Without Elbow Brace for Epicondylitis - a Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Tendinitis
U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Pain on visual analogue scale (VAS 0-10) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Pain on VAS (0=no pain, 10=worst pain)


Secondary Outcome Measures:
  • Grip strength (JAMAR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Grip strength (JAMAR, kg) in two elbow positions: 0° flexion and 90° flexion

  • Elbow microcirculation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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

  • DASH Score [0-100] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    DASH score [0=no impairment of daily activities, 100= severe impairment) before and 12 weeks after intervention
Estimated Enrollment: 90
Study Start Date: February 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 
Study First Received: January 3, 2011
Last Updated: January 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Arm Injuries

ClinicalTrials.gov processed this record on September 23, 2016