NCT01273688

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 10, 2011

Status Verified

January 1, 2011

Enrollment Period

9 months

First QC Date

January 3, 2011

Last Update Submit

January 7, 2011

Conditions

EpicondylitisTendinopathyPain

Keywords

painelbowtendinopathy

Outcome Measures

Primary Outcomes (1)

  • Pain on visual analogue scale (VAS 0-10)

    Pain on VAS (0=no pain, 10=worst pain)

    12 weeks

Secondary Outcomes (3)

  • Grip strength (JAMAR)

    12 weeks

  • Elbow microcirculation

    12 weeks

  • DASH Score [0-100]

    12 weeks

Study Arms (2)

Eccentric training only

ACTIVE COMPARATOR

Eccentric training only active control group (Flex-Bar)

Behavioral: Eccentric training (Flex-Bar)

Eccentric training and elbow brace

EXPERIMENTAL

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

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

Interventions

Eccentric training (Flex-Bar)BEHAVIORAL

6x15 repetitions of supination and pronation daily over 12 weeks

Eccentric training and elbow braceEccentric training only
EpiHit elbow braceDEVICE

daily wearing of the EpiHit elbow brace

Also known as: brace, orthosis, strap
Eccentric training and elbow brace

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lateral elbow tendinopathy
  • years informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (13)

  • 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.

    PMID: 20363158BACKGROUND

  • 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.

    PMID: 21081643BACKGROUND

  • Knobloch K. [Non-operative therapy in lateral epicondylitis]. MMW Fortschr Med. 2009 Feb 19;151(8):28-30. No abstract available. German.

    PMID: 19432271BACKGROUND

  • 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.

    PMID: 18978181BACKGROUND

  • 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.

    PMID: 20971969BACKGROUND

  • 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.

    PMID: 17496066BACKGROUND

  • 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.

    PMID: 20108186BACKGROUND

  • 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.

    PMID: 19997901BACKGROUND

  • 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.

    PMID: 21157656BACKGROUND

  • 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.

    PMID: 21157655BACKGROUND

  • Knobloch K, Hufner T. [Conservative treatment of Achilles tendinopathy]. Unfallchirurg. 2010 Sep;113(9):705-11. doi: 10.1007/s00113-010-1808-6. German.

    PMID: 20725821BACKGROUND

  • 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.

    PMID: 19106784BACKGROUND

  • 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.

    PMID: 18516593BACKGROUND

MeSH Terms

Conditions

TendinopathyPain

Interventions

BracesOrthotic Devices

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Karsten Knobloch, FACS, MD, PhD

    Hannover Medical School, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karsten Knobloch, FACS, MD, PhD

CONTACT

+495115328864knobloch.karsten@mh-hannover.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 10, 2011

Study Start

February 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

January 10, 2011

Record last verified: 2011-01

Locations

DE(1)