Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis

NCT ID: NCT01986465

Last Updated: 2013-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-11-30

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.

Detailed Description

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Conditions

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Lateral Epicondylitis

Keywords

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lateral epicondylitis treatment steroid immobilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Depomedrol

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Depomedrol

Intervention Type DRUG

Placebo

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Amir Moayednia

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamad A Tahririan, MD

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences

Locations

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Kashani University Hospital

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

References

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Ahmad Z, Siddiqui N, Malik SS, Abdus-Samee M, Tytherleigh-Strong G, Rushton N. Lateral epicondylitis: a review of pathology and management. Bone Joint J. 2013 Sep;95-B(9):1158-64. doi: 10.1302/0301-620X.95B9.29285.

Reference Type BACKGROUND
PMID: 23997125 (View on PubMed)

Other Identifiers

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387278

Identifier Type: -

Identifier Source: org_study_id