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

Hannover Medical School (MHH)

Status and phase: Unknown; Phase 3

Conditions: Epicondylitis; Pain; Tendinopathy

Treatments: Behavioral: Eccentric training (Flex-Bar); Device: EpiHit elbow brace

Study type: Interventional

Funder types: Other

Identifiers

NCT01273688

EpiFlex

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• lateral elbow tendinopathy
• 18-80 years informed consent

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Eccentric training only

Active Comparator group

Description:

Eccentric training only active control group (Flex-Bar)

Treatment:

Behavioral: Eccentric training (Flex-Bar)

Eccentric training and elbow brace

Experimental group

Description:

Combined eccentric training (Flex-Bar) and elbow brace (Epi-Hit)

Treatment:

Behavioral: Eccentric training (Flex-Bar)

Device: EpiHit elbow brace