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

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.

Study Overview

• Status: Unknown
• Conditions: Lateral Epicondylitis; Tennis Elbow
• Intervention / Treatment: Drug: Corticosteroid Injections; Drug: Prolotherapy; Drug: Placebo Injection; Behavioral: Physical Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Christine M. Kleinert Institute of Hand and Microsurgery
      • Contact: Millicent L Horn, BS; Phone Number: 502-562-0307; Email: mhorn@cmki.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	Drug: Prolotherapy; Subjects participating in the prolotherapy group will recieve 1 cc 50% Dextrose and Sodium Morrhuate 1 cc injections.
Placebo Comparator: Placebo; Participants will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).	Drug: Placebo Injection; Participants in the placebo group will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).
Active Comparator: 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.	Behavioral: Physical Therapy; Subjects participating in the physical therapy group will attend physical therapy and be prescribed to NSAIDS. No prolotherapy or corticosteroid injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Symptom Severity in pre intervention assessments	12 months
Symptom severity in post-intervention assessments	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Christine M. Kleinert Institute for Hand and Microsurgery
• Investigators: Principal Investigator: Tuna Ozyurekoglu, MD, Christine M. Kleinert Institute for Hand and Microsurgery

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: June 11, 2012
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: tennis elbow; lateral epicondylitis
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 11.0566