Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986465
• Other study ID #: 387278
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 11, 2013
• Last updated: November 11, 2013
• Start date: May 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Drug:
• Depomedrol

• Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Kashani University Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No