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EpicondylitisPhase 3EpiFlexNCT01273688

Eccentric Training With or Without Elbow Brace for Epicondylitis

A Phase 3 study testing Eccentric training (Flex-Bar) and EpiHit elbow brace in people with Epicondylitis and Tendinopathy, run by Hannover Medical School at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Epicondylitis, Tendinopathy, Pain
What is being tested?
Eccentric training (Flex-Bar) and EpiHit elbow brace
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteGermany
Study dates
Feb 2011to Nov 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • lateral elbow tendinopathy
  • 18-80 years informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Karsten Knobloch, FACS, MD, PhD contact

+495115328864

knobloch.karsten@mh-hannover.de

Germany1 site

  • Hannover Medical School

    Hanover, 30625

    Karsten Knobloch, FACS, MD, PhD, FACS, knobloch.karsten@mh-hannover.de

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Eccentric training (Flex-Bar), EpiHit elbow brace
Keywords
pain, elbow, tendinopathy
Medical subject headings
Tendinopathy, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eccentric training (Flex-Bar)Behavioural

    6x15 repetitions of supination and pronation daily over 12 weeks

  • EpiHit elbow braceDevice

    Also called brace, orthosis, strap

    daily wearing of the EpiHit elbow brace

Study groups in NCT01273688
Study groupRoleWhat they receive
Eccentric training onlyActive comparatorEccentric training only active control group (Flex-Bar)
Receives: Behavioral: Eccentric training (Flex-Bar)
Eccentric training and elbow braceExperimentalCombined eccentric training (Flex-Bar) and elbow brace (Epi-Hit)
Receives: Behavioral: Eccentric training (Flex-Bar); Device: EpiHit elbow brace

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain on visual analogue scale (VAS 0-10)

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

    Measured: 12 weeks

Secondary outcomes (3)

  1. Grip strength (JAMAR)

    Grip strength (JAMAR, kg) in two elbow positions: 0° flexion and 90° flexion

    Measured: 12 weeks

  2. 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

    Measured: 12 weeks

  3. DASH Score [0-100]

    DASH score [0=no impairment of daily activities, 100= severe impairment) before and 12 weeks after intervention

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionNov 2011 (estimated)
  4. Study completionNov 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01273688
Sponsor's protocol ID
EpiFlex
Acronym
EpiFlex
Status last verified
Jan 2011
First submitted
3 Jan 2011
Last updated
10 Jan 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20363158

  • 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.

    PubMed 21081643

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

    PubMed 19432271

  • 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.

    PubMed 18978181

  • 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.

    PubMed 20971969

  • 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.

    PubMed 17496066

  • 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.

    PubMed 20108186

  • 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.

    PubMed 19997901

  • 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.

    PubMed 21157656

  • 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.

    PubMed 21157655

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

    PubMed 20725821

  • 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.

    PubMed 19106784

  • 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.

    PubMed 18516593

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eccentric training (Flex-Bar) and EpiHit elbow brace in people with Epicondylitis and Tendinopathy, run by Hannover Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Karsten Knobloch, FACS, MD, PhD (+495115328864, knobloch.karsten@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain on visual analogue scale (VAS 0-10) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01273688, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2011.

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