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Eccentric Training With or Without Elbow Brace for Epicondylitis

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01273688
Acronym
EpiFlex
Enrollment
90
Registered
2011-01-10
Start date
2011-02-28
Completion date
2011-11-30
Last updated
2011-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epicondylitis, Pain, Tendinopathy

Keywords

pain, elbow, tendinopathy

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.

Interventions

BEHAVIORALEccentric training (Flex-Bar)

6x15 repetitions of supination and pronation daily over 12 weeks

DEVICEEpiHit elbow brace

daily wearing of the EpiHit elbow brace

Sponsors

Hannover Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Pain on visual analogue scale (VAS 0-10)12 weeksPain on VAS (0=no pain, 10=worst pain)

Secondary

MeasureTime frameDescription
Elbow microcirculation12 weeksOxygen-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]12 weeksDASH score \[0=no impairment of daily activities, 100= severe impairment) before and 12 weeks after intervention
Grip strength (JAMAR)12 weeksGrip strength (JAMAR, kg) in two elbow positions: 0° flexion and 90° flexion

Countries

Germany

Contacts

Primary ContactKarsten Knobloch, FACS, MD, PhD
knobloch.karsten@mh-hannover.de+495115328864

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026