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Efficacy Study of Prolotherapy vs Corticosteroid for Tennis Elbow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00160303
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 25, 2011
Information provided by:
Spaulding Rehabilitation Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Drug: Prolotherapy Drug: Local Corticosteroid Therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prolotherapy vs. Corticosteroid Therapy for the Treatment of Lateral Epicondylitis of the Elbow, A Randomized Controlled Trial.
Study Start Date : January 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 10 cm Visual Analogue Scale (VAS)
  2. Disabilities of the Arm, Shoulder, and Hand (DASH)

Secondary Outcome Measures :
  1. Grip Strength

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00160303

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United States, Massachusetts
Spaulding Rehabilitation Hospital, Wellesley Outpatient Center
Wellesley, Massachusetts, United States, 02481
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
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Principal Investigator: Joanne P Borg-Stein, MD Spaulding Rehabilitation Hospital
Study Director: Alexios G Carayannopoulos, DO, MPH Spaulding Rehabilitation Hospital
Layout table for additonal information Identifier: NCT00160303    
Other Study ID Numbers: 04-1561
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011
Keywords provided by Spaulding Rehabilitation Hospital:
Lateral Epicondylitis
Tennis Elbow
Corticosteroid Therapy
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries