Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study
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|ClinicalTrials.gov Identifier: NCT01897259|
Recruitment Status : Recruiting
First Posted : July 11, 2013
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tennis Elbow Lateral Epicondylitis||Drug: Placebo Injection Behavioral: Physical Therapy Drug: Corticosteroid Injections Drug: Prolotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
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.
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.
- Symptom Severity in pre intervention assessments [ Time Frame: 12 months ]
- Symptom severity in post-intervention assessments [ Time Frame: 12 months ]
- Functional status score pre-intervention [ Time Frame: 12 months ]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 ]The secondary outcome will be the functional status score by means of the QuickDash (Disabilities of Arm, Shoulder and Hand) for post intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897259
|Contact: Tuna Ozyurekoglu, MDfirstname.lastname@example.org|
|Contact: Millicent L Horn, BSemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Millicent L Horn, BS 502-562-0307 email@example.com|
|Principal Investigator: Tuna Ozyurekoglu, MD|
|Principal Investigator:||Tuna Ozyurekoglu, MD||Christine M. Kleinert Institute for Hand and Microsurgery|