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

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01897259
• Other study ID #: 11.0566
• Status: Recruiting
• Phase: Phase 2
• First received: June 11, 2012
• Last updated: January 23, 2018
• Start date: March 2012
• Est. completion date: June 2019

Study information

• Verified date: January 2018
• Source: Christine M. Kleinert Institute for Hand and Microsurgery
• Contact: Tuna Ozyurekoglu, MD
• Phone: 502-561-4286
• Email: tozyurekoglu[@]kleinertkutz.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• pain over the lateral epicondyle (via palpation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for less than six-months duration prior to enrollment

• conservative treatment of tennis elbow is recommended as standard of care treatment

• over the age of 18 and under the age of 65

• ability to give informed consent

Exclusion Criteria:

• treatment by a health care profession (MD, physicians assistnat, therapist, or nurse practitioner) within the previous 6 months for tennis elbow

• congenital deformities, tendon ruptures, or fractures of the elbow within the previous 12 months

• immobility casts or splints within the last 6 months for tennis elbow

• co-existing elbow diagnosis (i.e. osteoarthritis or instability)

• pregnant women, women trying to get pregnant, or breastfeeding women

• under the age of 18 or over the age of 65

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

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

Locations

Country	Name	City	State
United States	Christine M. Kleinert Institute of Hand and Microsurgery	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Christine M. Kleinert Institute for Hand and Microsurgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Severity in pre intervention assessments		12 months
Primary	Symptom severity in post-intervention assessments		12 months
Secondary	Functional status score pre-intervention	The secondary outcome will be by means of functional status score by means of QuickDASH (Disabilities of Arm, Shoulder, and Hand) prior to intervention.	12 months
Secondary	Functional status score severity- post intervention	The secondary outcome will be the functional status score by means of the QuickDash (Disabilities of Arm, Shoulder and Hand) for post intervention	12 months