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Eccentric Training With or Without Elbow Brace for Epicondylitis (EpiFlex)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Hannover Medical School.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
Hannover Medical School
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01273688
First received: January 3, 2011
Last updated: January 7, 2011
Last verified: January 2011
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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 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 |
Resource links provided by NLM:
Further study details as provided by Hannover Medical School:
Primary Outcome Measures:
- Pain on visual analogue scale (VAS 0-10) [ Time Frame: 12 weeks ]Pain on VAS (0=no pain, 10=worst pain)
Secondary Outcome Measures:
- 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
| 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:
|
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) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01273688
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 |
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 21, 2017