NCT01897259

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Christine M. Kleinert Institute for Hand and Microsurgery · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2013-07-11
• Last updated: 2018-01-25

Locations

1 site across 1 country: United States