Eccentric Training With or Without Elbow Brace for Epicondylitis

Pain Clinical Trial

— EpiFlex  

Official title:

Eccentric Training With Our Without Elbow Brace for Epicondylitis - a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01273688
• Other study ID #: EpiFlex
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 3, 2011
• Last updated: January 7, 2011
• Start date: February 2011
• Est. completion date: November 2011

Study information

• Verified date: January 2011
• Source: Hannover Medical School
• Contact: Karsten Knobloch, FACS, MD, PhD
• Phone: +495115328864
• Email: knobloch.karsten[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• lateral elbow tendinopathy

• 18-80 years informed consent

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epicondylitis
• Pain
• Tendinopathy

Intervention

Behavioral:
• Eccentric training (Flex-Bar)
6x15 repetitions of supination and pronation daily over 12 weeks

Device:
• EpiHit elbow brace
daily wearing of the EpiHit elbow brace

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

References & 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. — View 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. — View Citation

Knobloch K, Gohritz A. Dr Runge: a German pioneer in sclerosing therapy in epicondylitis in 1873. Br J Sports Med. 2010 Nov 16. [Epub ahead of print] — View Citation

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

Knobloch K, Krämer 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. — View 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. — View 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. Epub 2007 May 11. — View Citation

Knobloch K. [Non-operative therapy in lateral epicondylitis]. MMW Fortschr Med. 2009 Feb 19;151(8):28-30. German. — View 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. — View Citation

Knobloch K. Lateral elbow tendinopathy. Am J Sports Med. 2010 Nov;38(11):NP3; author reply NP3-4. doi: 10.1177/0363546510383492. — View 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. — View Citation

Krämer 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. Review. German. — View Citation

Lorenzen J, Krämer 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. Review. German. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on visual analogue scale (VAS 0-10)	Pain on VAS (0=no pain, 10=worst pain)	12 weeks	No
Secondary	Grip strength (JAMAR)	Grip strength (JAMAR, kg) in two elbow positions: 0° flexion and 90° flexion	12 weeks	No
Secondary	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	12 weeks	No
Secondary	DASH Score [0-100]	DASH score [0=no impairment of daily activities, 100= severe impairment) before and 12 weeks after intervention	12 weeks	No