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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epicondylitis Tendinopathy Pain | Behavioral: Eccentric training (Flex-Bar) Device: EpiHit elbow brace | Phase 3 |
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 (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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Eccentric training only
Eccentric training only active control group (Flex-Bar)
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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:
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- Pain on visual analogue scale (VAS 0-10) [ Time Frame: 12 weeks ]Pain on VAS (0=no pain, 10=worst pain)
- Grip strength (JAMAR) [ Time Frame: 12 weeks ]Grip strength (JAMAR, kg) in two elbow positions: 0° flexion and 90° flexion
- 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
- 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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- lateral elbow tendinopathy
- 18-80 years informed consent
Exclusion Criteria:
- no elbow tendinopathy <18 or > 80 years no informed consent

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
Contact: Karsten Knobloch, FACS, MD, PhD | +495115328864 | knobloch.karsten@mh-hannover.de |
Germany | |
Hannover Medical School | Not yet recruiting |
Hannover, Germany, 30625 | |
Contact: Karsten Knobloch, FACS, MD, PhD, FACS knobloch.karsten@mh-hannover.de |
Principal Investigator: | Karsten Knobloch, FACS, MD, PhD | Hannover Medical School, Germany |
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 |