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

NCT ID: NCT01897259

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2019-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Corticosteroid Injections

Patients will receive 1 cc Kenalong 10 mg injection to the site every 6 weeks until clinical symptoms have resolved. They will also receive an anesthetic of 1cc 1% lidocaine in conjunction with the corticosteroid injection.

Group Type: ACTIVE_COMPARATOR

Corticosteroid Injections

Intervention Type: DRUG

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

Participants receive 1cc 50% Dextrose and 1 cc Sodium Morrhuate to the site every 6 weeks until symptoms resolve. These participants will also receive an anesthetic of 1cc 1% lidocaine.

Group Type: ACTIVE_COMPARATOR

Prolotherapy

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo Injection

Intervention Type: DRUG

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

Physical Therapy

Participants will be prescribed NSAIDS (Diclofenac 75 mg BID) for 2 weeks. Participants will attend therapy for muscle stretches, soft tissue mobilization, and gradual strengthening.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: BEHAVIORAL

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

Interventions

Placebo Injection

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

Intervention Type: DRUG

Physical Therapy

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Prolotherapy

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Christine M. Kleinert Institute for Hand and Microsurgery

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tuna Ozyurekoglu, MD

Role: PRINCIPAL_INVESTIGATOR

Christine M. Kleinert Institute for Hand and Microsurgery

Locations

Christine M. Kleinert Institute of Hand and Microsurgery

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tuna Ozyurekoglu, MD

Role: CONTACT

tozyurekoglu@kleinertkutz.com

502-561-4286

Millicent L Horn, BS

Role: CONTACT

mhorn@cmki.org

502-562-0307

Facility Contacts

Christina L Kaufman, PhD

Role: primary

ckaufman@cmki.org

502-562-0390

Millicent L Horn, BS

Role: backup

mhorn@cmki.org

502-562-0307

Other Identifiers

11.0566

Identifier Type: -

Identifier Source: org_study_id