Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis

November 11, 2013 updated by: Amir Moayednia, Isfahan University of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Depomedrol
Placebo Comparator: 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.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function
Time Frame: 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.
Within the first 24 weeks after therapy
Pain
Time Frame: 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.
Within the first 24 weeks after therapy
Social-psychological
Time Frame: 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.
Within the first 24 weeks after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Principal Investigator: Mohamad A Tahririan, MD, Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 11, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Estimate)

November 18, 2013

Last Update Submitted That Met QC Criteria

November 11, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 387278

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lateral Epicondylitis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe