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

Phase 2

• Conditions: Tennis Elbow; Lateral Epicondylitis
• Interventions: Drug: Corticosteroid Injections; Drug: Prolotherapy; Drug: Placebo Injection; Behavioral: Physical Therapy

• Registration Number: NCT01897259
• Lead Sponsor: Christine M. Kleinert Institute for Hand and Microsurgery

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid Injections	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.
Prolotherapy	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.
Placebo	Placebo Injection	Participants will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).
Physical Therapy	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.

Primary Outcome Measures

Name	Time	Method
Symptom severity in post-intervention assessments	12 months
Symptom Severity in pre intervention assessments	12 months

Secondary Outcome Measures

Name	Time	Method
Functional status score pre-intervention	12 months	The secondary outcome will be by means of functional status score by means of QuickDASH (Disabilities of Arm, Shoulder, and Hand) prior to intervention.
Functional status score severity- post intervention	12 months	The secondary outcome will be the functional status score by means of the QuickDash (Disabilities of Arm, Shoulder and Hand) for post intervention

Trial Locations

Locations (1)

Christine M. Kleinert Institute of Hand and Microsurgery; 🇺🇸 Louisville, Kentucky, United States