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

Tracking Information

First Received Date ^ICMJE

January 3, 2011

Last Updated Date

January 7, 2011

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01273688 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Eccentric Training With or Without Elbow Brace for Epicondylitis

Official Title ^ICMJE

Eccentric Training With Our Without Elbow Brace for Epicondylitis - a Randomized Clinical Trial

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.

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Epicondylitis
Tendinopathy
Pain

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2011

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

lateral elbow tendinopathy
18-80 years informed consent

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Karsten Knobloch, FACS, MD, PhD

+495115328864

knobloch.karsten@mh-hannover.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01273688

Other Study ID Numbers ^ICMJE

EpiFlex

Has Data Monitoring Committee

Responsible Party

Hannover Medical School, Karsten Knobloch, FACS, MD, PhD, Hannover Medical School, Plastic, Hand and Reconstructive Surgery

Study Sponsor ^ICMJE

Hannover Medical School

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Karsten Knobloch, FACS, MD, PhD

Hannover Medical School, Germany

Information Provided By

Hannover Medical School

Verification Date

January 2011

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

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