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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Placebo | Placebo Comparator | Participants will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Injection | Drug | Participants in the placebo group will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline). |
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| Measure | Description | Time Frame |
|---|---|---|
| Symptom Severity in pre intervention assessments | 12 months | |
| Symptom severity in post-intervention assessments | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional status score pre-intervention | The secondary outcome will be by means of functional status score by means of QuickDASH (Disabilities of Arm, Shoulder, and Hand) prior to intervention. | 12 months |
| Functional status score severity- post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tuna Ozyurekoglu, MD | Contact | 502-561-4286 | tozyurekoglu@kleinertkutz.com | |
| Millicent L Horn, BS | Contact | 502-562-0307 | mhorn@cmki.org |
| Name | Affiliation | Role |
|---|---|---|
| Tuna Ozyurekoglu, MD | Christine M. Kleinert Institute for Hand and Microsurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christine M. Kleinert Institute of Hand and Microsurgery | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Physical Therapy | Behavioral | Subjects participating in the physical therapy group will attend physical therapy and be prescribed to NSAIDS. No prolotherapy or corticosteroid injections. |
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| 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. |
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| Prolotherapy | Drug | Subjects participating in the prolotherapy group will recieve 1 cc 50% Dextrose and Sodium Morrhuate 1 cc injections. |
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The secondary outcome will be the functional status score by means of the QuickDash (Disabilities of Arm, Shoulder and Hand) for post intervention |
| 12 months |
| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D000075527 | Prolotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000529 | Complementary Therapies |
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