Trial record 10 of 39 for:    Open Studies | "Elbow"

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

This study is currently recruiting participants.
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
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 April 17, 2014