Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Lateral Epicondylitis

Treatments: Drug: Placebo; Drug: Depomedrol

Study type: Interventional

Funder types: Other

Identifiers

NCT01986465

387278

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

Depomedrol

Experimental group

Description:

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.

Treatment:

Drug: Depomedrol

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo