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

Christine M. Kleinert Institute for Hand and Microsurgery

Status and phase: Unknown; Phase 2

Conditions: Tennis Elbow; Lateral Epicondylitis

Treatments: Drug: Placebo Injection; Drug: Corticosteroid Injections; Drug: Prolotherapy; Behavioral: Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01897259

11.0566

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups, including a placebo group

Corticosteroid Injections

Active Comparator group

Description:

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.

Treatment:

Drug: Corticosteroid Injections

Prolotherapy

Active Comparator group

Description:

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.

Treatment:

Drug: Prolotherapy

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Injection

Physical Therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physical Therapy