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NCT01476605 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Injection Therapy for Lateral Epicondylosis
A Phase 2 study of Tennis Elbow, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 2
- Study locations
NCT01476605 is a Phase 2 study of Tennis Elbow that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 31 participants, below the 126-participant average among 3 other Tennis Elbow trials with a reported enrollment target (75% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01476605, a Phase 2 study of Tennis Elbow, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 2
- Study locations
Study Summary
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?
Conditions Studied
Interventions
- PROCEDURE Dextrose prolotherapy
- PROCEDURE PrT-DMS
- PROCEDURE Platelet Rich Plasma injection
Study Locations (2)
Wisconsin
- Northeast Family Medical Center - Madison
- University of Wisconsin General Clinical Research Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2009-06 |
| Est. Completion | 2015-12-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01476605
The ClinicalTrials.gov registry entry for NCT01476605 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 126-participant average among 3 other Tennis Elbow trials with a reported enrollment target (75% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tennis Elbow appearing as the primary indexed condition, and to 3 interventions - of which Dextrose prolotherapy is the first listed.
NCT01476605 reports 2 study locations spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01476605 about?
NCT01476605 is a clinical study titled "Efficacy of Injection Therapy for Lateral Epicondylosis". 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 con...
What is the current status of trial NCT01476605?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2009-06. Estimated completion is 2015-12-01.
What conditions does trial NCT01476605 study?
This clinical trial studies the following conditions: Tennis Elbow.
What interventions are being tested in trial NCT01476605?
The interventions under investigation include: Dextrose prolotherapy (PROCEDURE), PrT-DMS (PROCEDURE), Platelet Rich Plasma injection (PROCEDURE).
Who is sponsoring clinical trial NCT01476605?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01476605 being conducted?
This trial has 2 study locations across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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