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Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study

NCT01897259 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-01-25

No results posted yet for this study

Summary

This is a prospective study where patients with lateral epicondylitis (tennis elbow) will be randomized into one of 4 possible treatments. The purpose is to individually examine the efficacy of each treatment, and determine if one treatment method is more effective than another. The four treatments are: corticosteriod injections, prolotherapy, NSAIDs (non-steroidal anti-inflammatory drugs) combined with physical therapy, and a placebo.

Conditions

  • Tennis Elbow
  • Lateral Epicondylitis

Interventions

DRUG

Placebo Injection

Participants in the placebo group will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).

BEHAVIORAL

Physical Therapy

Subjects participating in the physical therapy group will attend physical therapy and be prescribed to NSAIDS. No prolotherapy or corticosteroid injections.

DRUG

Corticosteroid Injections

Participants in the corticosteroid group will recieve corticosteroid injections (1 cc Kenalog 10 mg). They will also recieve anesthetic of 1 ml 1% lidocaine.

DRUG

Prolotherapy

Subjects participating in the prolotherapy group will recieve 1 cc 50% Dextrose and Sodium Morrhuate 1 cc injections.

Sponsors & Collaborators

  • Christine M. Kleinert Institute for Hand and Microsurgery

    lead OTHER

Principal Investigators

  • Tuna Ozyurekoglu, MD · Christine M. Kleinert Institute for Hand and Microsurgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01897259 on ClinicalTrials.gov