Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effectiveness of steroid injection and immobilization versus no immobilization in treating patients with lateral epicondylitis.

Official Title
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Comparing the Effectiveness of Steroid Injection Versus Placebo and Immobilization Versus no Immobilization in Treating Patients With Lateral Epicondylitis

Conditions
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Lateral Epicondylitis

Intervention / Treatment
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* Drug: Depomedrol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 65 years confirmed lateral epicondylitis had not received any treatment prior to enrolment Exclusion Criteria: symptoms lasting less than 6 weeks history of acute trauma, fracture, and/or surgery within 12 months patients who had received corticosteroid injection, physiotherapy, splint or casting during the past 6 months bilateral involvement and history of cervical disk herniation, radiculopathy or abnormal electrophysiologic study

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Depomedrol<br>The trial pharmacist prepares a series of similar vials containing either 4 mg of Depomedrol or Normal Saline and coded them either 1, 2, 3 or 4, the group assignments are not decoded until the end of the trial when the final analysis is due to take place. Patients take their envelopes to the trial pharmacist who give them a coded vial which they take to the orthopaedic surgeon who make the injection. After the injection the trial clerk take the patients to a technician who give patients in groups 1 and 3 long arm splints. | Drug: Depomedrol<br> <br> |
| Placebo Comparator: Placebo<br>The trial pharmacist prepares a series of similar vials containing either 4 mg of Depomedrol or Normal Saline and coded them either 1, 2, 3 or 4, the group assignments are not decoded until the end of the trial when the final analysis is due to take place. Patients take their envelopes to the trial pharmacist who give them a coded vial which they take to the orthopaedic surgeon who make the injection. After the injection the trial clerk take the patients to a technician who give patients in groups 1 and 3 long arm splints. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function | The trial subjects are evaluated using the Oxford Elbow Scale (OES). They are asked to come to the trial office at 2 weeks, 4 weeks and 24 weeks for follow-up evaluation by administration of OES. | Within the first 24 weeks after therapy | 
| Pain | The trial subjects are evaluated using the Oxford Elbow Scale (OES). They are asked to come to the trial office at 2 weeks, 4 weeks and 24 weeks for follow-up evaluation by administration of OES. | Within the first 24 weeks after therapy | 
| Social-psychological | The trial subjects are evaluated using the Oxford Elbow Scale (OES). They are asked to come to the trial office at 2 weeks, 4 weeks and 24 weeks for follow-up evaluation by administration of OES. | Within the first 24 weeks after therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lateral epicondylitis, treatment, steroid, immobilization