Trial record 4 of 15 for:    Open Studies | "Tennis Elbow"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor:
Information provided by (Responsible Party):
Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:
NCT01897259
First received: June 11, 2012
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Tennis Elbow
Lateral Epicondylitis
Drug: Placebo Injection
Behavioral: Physical Therapy
Drug: Corticosteroid Injections
Drug: Prolotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study

Resource links provided by NLM:


Further study details as provided by Christine M. Kleinert Institute for Hand and Microsurgery:

Primary Outcome Measures:
  • Symptom Severity in pre intervention assessments [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Symptom severity in post-intervention assessments [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional status score pre-intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The secondary outcome will be the functional status score by means of the QuickDash (Disabilities of Arm, Shoulder and Hand) for post intervention


Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897259

Contacts
Contact: Tuna Ozyurekoglu, MD 502-561-4286 tozyurekoglu@kleinertkutz.com
Contact: Ross D Gibson, BA 502-562-0307 rgibson@cmki.org

Locations
United States, Kentucky
Christine M. Kleinert Institute of Hand and Microsurgery Recruiting
Louisville, Kentucky, United States, 40202
Contact: Christina L Kaufman, PhD    502-562-0390    ckaufman@cmki.org   
Contact: Ross D Gibson, BA    502-562-0307    rgibson@cmki.org   
Principal Investigator: Tuna Ozyurekoglu, MD         
Sponsors and Collaborators
Christine M. Kleinert Institute for Hand and Microsurgery
Investigators
Principal Investigator: Tuna Ozyurekoglu, MD Christine M. Kleinert Institute for Hand and Microsurgery
  More Information

No publications provided

Responsible Party: Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier: NCT01897259     History of Changes
Other Study ID Numbers: 11.0566
Study First Received: June 11, 2012
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery:
tennis elbow
lateral epicondylitis

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Sodium Morrhuate
Sclerosing Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014