The purpose of the research is to study the effects of two different injection therapies for the treatment of lateral epicondylitis (tennis elbow). Specifically, we will look at which therapy provides better short and long-term relief of pain, which treatment allows better function and less disability, and which treatment gives back better strength in the affected hand. Each subject will receive only one of the two treatments. Although both of these treatments are usually very well tolerated, it is important to make this comparison because it is believed that one of these therapies may have better long term effectiveness, with a lower cost, and smaller number of potential side effects.

Official Title

Prolotherapy vs. Corticosteroid Therapy for the Treatment of Lateral Epicondylitis of the Elbow, A Randomized Controlled Trial.


  • Lateral Epicondylitis

Study Type


Study Design

Treatment, Randomised, Double-Blind, Active Control, Single Group Assignment, Efficacy Study.

Further Details

  Primary Outcome Measures:

  • 10 cm Visual Analogue Scale (VAS)
  • Disabilities of the Arm, Shoulder, and Hand (DASH)

Secondary Outcome Measures:

  • Grip Strength

Study Start

January 2005

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years to 75 Years
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: Yes

Inclusion Criteria:

  • Age criteria >18yo, <75yo, history of pain > 3 months, < 2 years; pain on resisted extension of wrist and/or middle finger test, (resisted extension of middle finger at the MCP joint)
  • Local tenderness to palpation at the lateral epicondyle
  • Subject can read and write in English.

Exclusion Criteria:

  • History of steroid injections within 6 months prior to intervention;
  • Other arm/forearm pathology such as radial nerve compression; pregnancy/nursing;
  • Known thrombocytopenia, coagulopathy, or bleeding diathesis; history of diffuse pain syndrome;
  • History of Inflammatory Arthropathy;
  • Workman’s Compensation (RSI) > 2 years; patients with litigation pending/planned; patients who are unable to return for F/U;
  • Intolerance/allergy to local anesthetics or injection corticosteroids; fear of needles; untreated depression;
  • History of narcotic use for pain management greater than 1 month or history of narcotic abuse problem.

Total Enrolment


Contact Details

Joanne Borg-Stein, MD

Alexios Carayannopoulos, DO, MPH


Spaulding Rehabilitation Hospital
Wellesley Outpatient Center
Wellesley, Massachusetts
United States, 02481