Recruiting
Phase 2

Conservative Methods

Sponsor:

Christine M. Kleinert Institute for Hand and Microsurgery

Code:

NCT01897259

Conditions

Tennis Elbow

Lateral Epicondylitis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Placebo Injection

Physical Therapy

Corticosteroid Injections

Prolotherapy

Study Details

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 ID

NCT01897259

Start date

Mar, 2012

Status verified date

Jan, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

placebo comparator: Placebo

Participants 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.

Interventions

Placebo Injection

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

Physical Therapy

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

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.

Prolotherapy

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

Primary outcome measure

  • Symptom Severity in pre intervention assessments [ Time Frame: 12 months ]
  • Symptom severity in post-intervention assessments [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Tuna Ozyurekoglu, MD

502-561-4286tozyurekoglu@kleinertkutz.com

Millicent L Horn, BS

502-562-0307mhorn@cmki.org

Locations

Christine M. Kleinert Institute of Hand and Microsurgery

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Christina L Kaufman, PhD

502-562-0390ckaufman@cmki.org

Millicent L Horn, BS

502-562-0307mhorn@cmki.org

Principal Investigator:

Tuna Ozyurekoglu, MD

More Information

Sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

Last update posted

Jan 25, 2018

Last verified

Jan, 2018

Keywords

  • tennis elbow
  • lateral epicondylitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christine M. Kleinert Institute for Hand and Microsurgery on 2018-01-25.