Eccentric Training With or Without Elbow Brace for Epicondylitis

Phase 3

• Conditions: Tendinopathy; Epicondylitis; Pain
• Interventions: Behavioral: Eccentric training (Flex-Bar); Device: EpiHit elbow brace

• Registration Number: NCT01273688
• Lead Sponsor: Hannover Medical School

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 Timeline

• Status Verified: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-07
• Last Update Submitted: 2011-01-07
• Study First Posted: 2011-01-10
• Last Update Posted: 2011-01-10
• Study Start: 2011-02
• Primary Completion: 2011-11
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• lateral elbow tendinopathy
• 18-80 years informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eccentric training only	Eccentric training (Flex-Bar)	Eccentric training only active control group (Flex-Bar)
Eccentric training and elbow brace	Eccentric training (Flex-Bar)	Combined eccentric training (Flex-Bar) and elbow brace (Epi-Hit)
Eccentric training and elbow brace	EpiHit elbow brace	Combined eccentric training (Flex-Bar) and elbow brace (Epi-Hit)

Primary Outcome Measures

Name	Time	Method
Pain on visual analogue scale (VAS 0-10)	12 weeks	Pain on VAS (0=no pain, 10=worst pain)

Secondary Outcome Measures

Name	Time	Method
Grip strength (JAMAR)	12 weeks	Grip strength (JAMAR, kg) in two elbow positions: 0° flexion and 90° flexion
Elbow microcirculation	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]	12 weeks	DASH score \[0=no impairment of daily activities, 100= severe impairment) before and 12 weeks after intervention

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany