Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis

Phase 2

Completed

• Conditions: Lateral Epicondylitis
• Interventions: Drug: Depomedrol; Drug: Placebo

• Registration Number: NCT01986465
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-11
• Last Update Submitted: 2013-11-11
• Study First Posted: 2013-11-18
• Last Update Posted: 2013-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Depomedrol	Depomedrol	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.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Function	Within the first 24 weeks after therapy	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.
Pain	Within the first 24 weeks after therapy	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.
Social-psychological	Within the first 24 weeks after therapy	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.

Trial Locations

Locations (1)

Kashani University Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of