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

January 7, 2011 updated by: Hannover Medical School

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • lateral elbow tendinopathy
  • 18-80 years informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on visual analogue scale (VAS 0-10)
Time Frame: 12 weeks
Pain on VAS (0=no pain, 10=worst pain)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip strength (JAMAR)
Time Frame: 12 weeks
Grip strength (JAMAR, kg) in two elbow positions: 0° flexion and 90° flexion
12 weeks
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
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Principal Investigator: Karsten Knobloch, FACS, MD, PhD, Hannover Medical School, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Estimate)

January 10, 2011

Last Update Submitted That Met QC Criteria

January 7, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EpiFlex

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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