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Clinical trialNCT01476605CompletedPhase 2Interventional

Efficacy of Injection Therapy for Lateral Epicondylosis

SponsorUniversity of Wisconsin, MadisonEnrollment31Tennis Elbow
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

While evidence does not identify any conventional therapy as definitive for chronic lateral epicondylosis (CLE, tennis elbow), basic science and limited pilot level trials support rigorous assessment of prolotherapy (PrT) and platelet-rich plasma (PRP) as therapy for CLE. The proposed study will conduct a pilot RCT assessing 2 PrT solutions and PRP injections commonly used in the treatment of moderate-to-severe tennis elbow using clinical, biomechanical and radiological outcomes. Data from this study will support a future confirmatory study to find an effective treatment for moderate-to-severe tennis elbow. In support of this goal, the investigators propose the following research questions. Does PrT or PRP, compared to waitlist control: 1. improve pain- and function-dependent, CLE-specific quality of life among adults with CLE, as assessed by a validated questionnaire, the elbow-specific Patient-Rated Tennis Elbow Evaluation? 2. improve upper extremity performance among adults with CLE as assessed by a blinded assessor using elbow-specific, effort-dependent biomechanical measures of grip strength (pain-free and maximal), stiffness, effective mass and damping 3. improve the radiologic appearance of several pathologic features of CLE as evaluated using imaging studies of lateral elbow structures: ultrasound to assess a) neovascularity (color Doppler), b) hypoechogenicity (grayscale US), and c) tendon stiffness ("acousto-elastic strain gauge" technique) using standardized, 0-3 severity scales, and d) MRI to assess the overall common extensor tensor tendon disease severity using a standardized 0-3 scale? 4. provide satisfying treatment to subjects as assessed by a treatment satisfaction survey and a qualitative exit interview?

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Northeast Family Medical Center

    Madison, Wisconsin, United States

  • University of Wisconsin General Clinical Research Center

    Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Jun 2009
Primary completion
1 Nov 2011
Completion
1 Dec 2015
Last update posted
18 Feb 2019
Registered enrollment
31
Registry id
NCT01476605

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.