Principal Investigator: David Rabago, MD

PI Department: Department of Family Medicine

Project Study Title: Prolotherapy for Chronic Tennis Elbow

Study Summary: The study is a 32 week randomized clinical trial of prolotherapy as a treatment for severe lateral epicondylosis (tennis elbow). People between the ages of 18 and 65 who have had tennis elbow for longer than 6 months are eligible. All subjects will be paid for time and travel.

Study Objective: The study will compare treatment with prolotherapy, an injection technique, to 'no treatment' over 16 weeks. Subjects in the no treatment group will have the option to receive prolotherapy at no cost if it proves to be effective.

Other objectives are to determine whether prolotherapy improves biomechanical performance, radiological appearance, tendon stiffness and patient satisfaction compared to waitlist control. Subjects will have the opportunity to have their elbows assessed for strength and appearance with ultrasound and magnetic resonance imaging (MRI).

Study Design: 30 participants will be randomized into one of three groups: 1) dextrose injections, 2) dextrose and sodium morrhuate injections, or 3) 'watchful waiting'.

All groups from Week 0 through Week 16 receive:
1. 3 survey interviews with questions about general health, demographics, elbow pain and function, satisfaction with treatment.
2. 3 clinic visits for biomechanical assessment of function.
3. 3 clinic visits for ultrasound assessments of structural soft tissue changes specific to tennis elbow.

In addition, subjects in the Prolotherapy group receive:
1. 3 sessions of ultrasound guided prolotherapy during weeks 0 through 8
2. Magnetic resonance imaging elbow scans at 0 and 32 weeks
3. 1 additional ultrasound assessment at 32 weeks.

DFM Clinic(s): Northeast Family Medical Center

DFM Contact: Mary Beth Plane, PhD

Study Contact Person:

Jessica Grettie
Senior Research Specialist/Study Coordinator
608-265-4200
jessica.grettie@fammed.wisc.edu

Date of Approval: April 1, 2009

Dates of Study: June, 2009 - September, 2010