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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

January 3, 2011
January 7, 2011
February 2011
November 2011   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01273688 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Eccentric Training With or Without Elbow Brace for Epicondylitis
Eccentric Training With Our Without Elbow Brace for Epicondylitis - a Randomized Clinical Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Epicondylitis
  • Tendinopathy
  • Pain
  • 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
  • Active Comparator: Eccentric training only
    Eccentric training only active control group (Flex-Bar)
    Intervention: Behavioral: Eccentric training (Flex-Bar)
  • Experimental: Eccentric training and elbow brace
    Combined eccentric training (Flex-Bar) and elbow brace (Epi-Hit)
    Interventions:
    • Behavioral: Eccentric training (Flex-Bar)
    • Device: EpiHit elbow brace

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
90
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • lateral elbow tendinopathy
  • 18-80 years informed consent

Exclusion Criteria:

  • no elbow tendinopathy <18 or > 80 years no informed consent
Both
18 Years to 80 Years
No
Contact: Karsten Knobloch, FACS, MD, PhD +495115328864 knobloch.karsten@mh-hannover.de
Germany
 
NCT01273688
EpiFlex
No
Hannover Medical School, Karsten Knobloch, FACS, MD, PhD, Hannover Medical School, Plastic, Hand and Reconstructive Surgery
Hannover Medical School
Not Provided
Principal Investigator: Karsten Knobloch, FACS, MD, PhD Hannover Medical School, Germany
Hannover Medical School
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP