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Efficacy Study of Prolotherapy vs Corticosteroid for Tennis Elbow

This study has been completed.
Sponsor:
Information provided by:
Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT00160303
First received: September 8, 2005
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Lateral Epicondylitis
 Drug: Prolotherapy
Drug: Local Corticosteroid Therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prolotherapy vs. Corticosteroid Therapy for the Treatment of Lateral Epicondylitis of the Elbow, A Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spaulding Rehabilitation Hospital:

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

Secondary Outcome Measures:
  • Grip Strength

Estimated Enrollment: 56
Study Start Date: January 2005
Study Completion Date: December 2006
  Show Detailed Description

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160303

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital, Wellesley Outpatient Center
Wellesley, Massachusetts, United States, 02481
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Joanne P Borg-Stein, MD Spaulding Rehabilitation Hospital
Study Director: Alexios G Carayannopoulos, DO, MPH Spaulding Rehabilitation Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00160303     History of Changes
Other Study ID Numbers: 04-1561, 2005P-001080
Study First Received: September 8, 2005
Last Updated: July 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
Prolotherapy
Lateral Epicondylitis
Tennis Elbow
Corticosteroid Therapy

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013