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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tennis Elbow, Lateral Epicondylitis

Intervention / Treatment
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* Drug: Placebo Injection
* Behavioral: Physical Therapy
* Drug: Corticosteroid Injections
* Drug: Prolotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Corticosteroid Injections<br>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<br>* Participants in the corticosteroid group will recieve corticosteroid injections (1 cc Kenalog 10 mg). They will also recieve anesthetic of 1 ml 1% lidocaine.<br>|
| Active Comparator: Prolotherapy<br>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<br>* Subjects participating in the prolotherapy group will recieve 1 cc 50% Dextrose and Sodium Morrhuate 1 cc injections.<br>|
| Placebo Comparator: Placebo<br>Participants will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline). | Drug: Placebo Injection<br>* Participants in the placebo group will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).<br>|
| Active Comparator: Physical Therapy<br>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<br>* Subjects participating in the physical therapy group will attend physical therapy and be prescribed to NSAIDS. No prolotherapy or corticosteroid injections.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Severity in pre intervention assessments |  | 12 months | 
| Symptom severity in post-intervention assessments |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tennis elbow, lateral epicondylitis