search
Back to results

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

Primary Purpose

Epicondylitis, Tendinopathy, Pain

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Eccentric training (Flex-Bar)
EpiHit elbow brace
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epicondylitis focused on measuring pain, elbow, tendinopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • lateral elbow tendinopathy
  • 18-80 years informed consent

Exclusion Criteria:

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

Sites / Locations

  • Hannover Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Eccentric training only

Eccentric training and elbow brace

Arm Description

Eccentric training only active control group (Flex-Bar)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2011
Last Updated
January 7, 2011
Sponsor
Hannover Medical School
search

1. Study Identification

Unique Protocol Identification Number
NCT01273688
Brief Title
Eccentric Training With or Without Elbow Brace for Epicondylitis
Acronym
EpiFlex
Official Title
Eccentric Training With Our Without Elbow Brace for Epicondylitis - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hannover Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis, Tendinopathy, Pain
Keywords
pain, elbow, tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eccentric training only
Arm Type
Active Comparator
Arm Description
Eccentric training only active control group (Flex-Bar)
Arm Title
Eccentric training and elbow brace
Arm Type
Experimental
Arm Description
Combined eccentric training (Flex-Bar) and elbow brace (Epi-Hit)
Intervention Type
Behavioral
Intervention Name(s)
Eccentric training (Flex-Bar)
Intervention Description
6x15 repetitions of supination and pronation daily over 12 weeks
Intervention Type
Device
Intervention Name(s)
EpiHit elbow brace
Other Intervention Name(s)
brace, orthosis, strap
Intervention Description
daily wearing of the EpiHit elbow brace
Primary Outcome Measure Information:
Title
Pain on visual analogue scale (VAS 0-10)
Description
Pain on VAS (0=no pain, 10=worst pain)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Grip strength (JAMAR)
Description
Grip strength (JAMAR, kg) in two elbow positions: 0° flexion and 90° flexion
Time Frame
12 weeks
Title
Elbow microcirculation
Description
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
Time Frame
12 weeks
Title
DASH Score [0-100]
Description
DASH score [0=no impairment of daily activities, 100= severe impairment) before and 12 weeks after intervention
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: lateral elbow tendinopathy 18-80 years informed consent Exclusion Criteria: no elbow tendinopathy <18 or > 80 years no informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karsten Knobloch, FACS, MD, PhD
Phone
+495115328864
Email
knobloch.karsten@mh-hannover.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Knobloch, FACS, MD, PhD
Organizational Affiliation
Hannover Medical School, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karsten Knobloch, FACS, MD, PhD, FACS
Email
knobloch.karsten@mh-hannover.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
20363158
Citation
Garg R, Adamson GJ, Dawson PA, Shankwiler JA, Pink MM. A prospective randomized study comparing a forearm strap brace versus a wrist splint for the treatment of lateral epicondylitis. J Shoulder Elbow Surg. 2010 Jun;19(4):508-12. doi: 10.1016/j.jse.2009.12.015. Epub 2010 Apr 2.
Results Reference
background
PubMed Identifier
21081643
Citation
Knobloch K, Gohritz A. Dr Runge: a German pioneer in sclerosing therapy in epicondylitis in 1873. Br J Sports Med. 2010 Nov 16. doi: 10.1136/bjsm.2008.051326. Online ahead of print. No abstract available.
Results Reference
background
PubMed Identifier
19432271
Citation
Knobloch K. [Non-operative therapy in lateral epicondylitis]. MMW Fortschr Med. 2009 Feb 19;151(8):28-30. No abstract available. German.
Results Reference
background
PubMed Identifier
18978181
Citation
Knobloch K. Re: Radiofrequency microtenotomy: a promising method for treatment of recalcitrant lateral epicondylitis. Am J Sports Med. 2008 Nov;36(11):e2-3; author reply e3. doi: 10.1177/0363546508325661. No abstract available.
Results Reference
background
PubMed Identifier
20971969
Citation
Knobloch K. Lateral elbow tendinopathy. Am J Sports Med. 2010 Nov;38(11):NP3; author reply NP3-4. doi: 10.1177/0363546510383492. No abstract available.
Results Reference
background
PubMed Identifier
17496066
Citation
Knobloch K, Spies M, Busch KH, Vogt PM. Sclerosing therapy and eccentric training in flexor carpi radialis tendinopathy in a tennis player. Br J Sports Med. 2007 Dec;41(12):920-1. doi: 10.1136/bjsm.2007.036558. Epub 2007 May 11.
Results Reference
background
PubMed Identifier
20108186
Citation
Knobloch K, Kramer R, Redeker J, Spies M, Vogt PM. [Scaphoid fracture in motocross riders]. Sportverletz Sportschaden. 2009 Dec;23(4):217-20. doi: 10.1055/s-0028-1109927. Epub 2009 Dec 15. German.
Results Reference
background
PubMed Identifier
19997901
Citation
Knobloch K, Schreibmueller L, Kraemer R, Jagodzinski M, Vogt PM, Redeker J. Gender and eccentric training in Achilles mid-portion tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2010 May;18(5):648-55. doi: 10.1007/s00167-009-1006-7. Epub 2009 Dec 9.
Results Reference
background
PubMed Identifier
21157656
Citation
Kramer R, Lorenzen J, Vogt PM, Knobloch K. [Systematic review about eccentric training in chronic achilles tendinopathy]. Sportverletz Sportschaden. 2010 Dec;24(4):204-11. doi: 10.1055/s-0029-1245820. Epub 2010 Dec 14. German.
Results Reference
background
PubMed Identifier
21157655
Citation
Lorenzen J, Kramer R, Vogt PM, Knobloch K. [Systematic review about eccentric training in chronic patella tendinopathy]. Sportverletz Sportschaden. 2010 Dec;24(4):198-203. doi: 10.1055/s-0029-1245818. Epub 2010 Dec 14. German.
Results Reference
background
PubMed Identifier
20725821
Citation
Knobloch K, Hufner T. [Conservative treatment of Achilles tendinopathy]. Unfallchirurg. 2010 Sep;113(9):705-11. doi: 10.1007/s00113-010-1808-6. German.
Results Reference
background
PubMed Identifier
19106784
Citation
Knobloch K. Eccentric training and the science behind. Med Sci Sports Exerc. 2009 Jan;41(1):251; author reply 252. doi: 10.1249/MSS.0b013e31818cae4b. No abstract available.
Results Reference
background
PubMed Identifier
18516593
Citation
Knobloch K, Gohritz A, Spies M, Vogt PM. Neovascularisation in de Quervain's disease of the wrist: novel combined therapy using sclerosing therapy with polidocanol and eccentric training of the forearms and wrists-a pilot report. Knee Surg Sports Traumatol Arthrosc. 2008 Aug;16(8):803-5. doi: 10.1007/s00167-008-0555-5. Epub 2008 May 31.
Results Reference
background

Learn more about this trial

Eccentric Training With or Without Elbow Brace for Epicondylitis

We'll reach out to this number within 24 hrs