Efficacy Study of Prolotherapy vs Corticosteroid for Tennis Elbow

NCT00160303 | Completed Phase 3

• 2 other identifiers: 04-15612005P-001080
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis

Keywords

Prolotherapy; Lateral Epicondylitis; Tennis Elbow; Corticosteroid Therapy

Outcome Measures

Primary Outcomes (2)

• 10 cm Visual Analogue Scale (VAS)

• Disabilities of the Arm, Shoulder, and Hand (DASH)

Secondary Outcomes (1)

• Grip Strength

Interventions

Prolotherapy DRUG

Local Corticosteroid Therapy DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital, Wellesley Outpatient Center

Wellesley, Massachusetts, 02481, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Prolotherapy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Joanne P Borg-Stein, MD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

• Alexios G Carayannopoulos, DO, MPH

  Spaulding Rehabilitation Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2005
• Study Completion: December 1, 2006
• Last Updated: July 25, 2011

Record last verified: 2011-07

Locations

US (1)