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Efficacy of Injection Therapy for Lateral Epicondylosis

NCT01476605 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-02-18

No results posted yet for this 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

  • Tennis Elbow

Interventions

PROCEDURE

Dextrose prolotherapy

PrT-D solution is 4 mL 50% dextrose, 3 mL normal saline, and 2 mL 2% lidocaine

PROCEDURE

PrT-DMS

PrT-DMS. 1.0 mL 5% morrhuate sodium + 1.5 mL 50% dextrose, 1 mL 2% lidocaine and 3.5 mL normal saline.

PROCEDURE

Platelet Rich Plasma injection

Platelet rich plasma injection therapy (PRP) uses components of autologous blood to promote healing in chronically diseased joint tissues.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • David P Rabago, MD · University of Wisconsin, Department of Family Medicine

  • John Wilson, MD · UW Dept of Family Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-11-01
Completion
2015-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01476605 on ClinicalTrials.gov