Eccentric Training With or Without Elbow Brace for Epicondylitis

NCT ID: NCT01273688

Last Updated: 2011-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Epicondylitis Tendinopathy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Eccentric training only

Eccentric training only active control group (Flex-Bar)

Group Type ACTIVE_COMPARATOR

Eccentric training (Flex-Bar)

Intervention Type BEHAVIORAL

6x15 repetitions of supination and pronation daily over 12 weeks

Eccentric training and elbow brace

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

Group Type EXPERIMENTAL

Eccentric training (Flex-Bar)

Intervention Type BEHAVIORAL

6x15 repetitions of supination and pronation daily over 12 weeks

EpiHit elbow brace

Intervention Type DEVICE

daily wearing of the EpiHit elbow brace

Interventions

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Eccentric training (Flex-Bar)

6x15 repetitions of supination and pronation daily over 12 weeks

Intervention Type BEHAVIORAL

EpiHit elbow brace

daily wearing of the EpiHit elbow brace

Intervention Type DEVICE

Other Intervention Names

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brace orthosis strap

Eligibility Criteria

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Inclusion Criteria

* lateral elbow tendinopathy
* 18-80 years informed consent

Exclusion Criteria

* no elbow tendinopathy \<18 or \> 80 years no informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Hannover Medical School, Plastic, Hand and Reconstructive Surgery

Principal Investigators

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Karsten Knobloch, FACS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School, Germany

Locations

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Hannover Medical School

Hanover, , Germany

Site Status

Countries

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Germany

Central Contacts

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Karsten Knobloch, FACS, MD, PhD

Role: CONTACT

+495115328864

Facility Contacts

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Karsten Knobloch, FACS, MD, PhD, FACS

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 20363158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21081643 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 19432271 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18978181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20971969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17496066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20108186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19997901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21157656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21157655 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 20725821 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19106784 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18516593 (View on PubMed)

Other Identifiers

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EpiFlex

Identifier Type: -

Identifier Source: org_study_id

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