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

NCT01897259 | Unknown Phase 2

• 1 other identifier: 11.0566
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

tennis elbow; lateral epicondylitis

Outcome Measures

Primary Outcomes (2)

• Symptom Severity in pre intervention assessments

  12 months

• Symptom severity in post-intervention assessments

  12 months

Secondary Outcomes (2)

• Functional status score pre-intervention

  12 months

• Functional status score severity- post intervention

  12 months

Study Arms (4)

Corticosteroid Injections

ACTIVE COMPARATOR

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

Prolotherapy

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Injection

Physical Therapy

ACTIVE COMPARATOR

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

Interventions

Placebo Injection DRUG

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

Placebo

Physical Therapy BEHAVIORAL

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

Physical Therapy

Corticosteroid Injections 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.

Corticosteroid Injections

Prolotherapy DRUG

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

Prolotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christine M. Kleinert Institute for Hand and Microsurgery: lead

Study Sites (1)

Christine M. Kleinert Institute of Hand and Microsurgery

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

Physical Therapy Modalities; Prolotherapy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Complementary Therapies

Study Officials

• Tuna Ozyurekoglu, MD

  Christine M. Kleinert Institute for Hand and Microsurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuna Ozyurekoglu, MD

CONTACT

502-561-4286; tozyurekoglu@kleinertkutz.com

Millicent L Horn, BS

CONTACT

502-562-0307; mhorn@cmki.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: July 11, 2013
• Study Start: March 1, 2012
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

US (1)