Comparing the Effectiveness of Steroid Injection Versus Placebo and Immobilization Versus no Immobilization in Treating Patients With Lateral Epicondylitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Depomedrol (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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Amir Moayednia
Dr.
Isfahan University of Medical Sciences