Back to resultsEffectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis
Primary Purpose
Lateral Epicondylitis
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Depomedrol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring lateral epicondylitis, treatment, steroid, immobilization
Eligibility Criteria
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
Sites / Locations
- Kashani University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Depomedrol
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01986465
First Posted
November 11, 2013
Last Updated
November 11, 2013
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01986465
Brief Title
Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis
Official Title
Comparing the Effectiveness of Steroid Injection Versus Placebo and Immobilization Versus no Immobilization in Treating Patients With Lateral Epicondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
lateral epicondylitis, treatment, steroid, immobilization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Depomedrol
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Depomedrol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Function
Description
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.
Time Frame
Within the first 24 weeks after therapy
Title
Pain
Description
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.
Time Frame
Within the first 24 weeks after therapy
Title
Social-psychological
Description
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.
Time Frame
Within the first 24 weeks after therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad A Tahririan, MD
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kashani University Hospital
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23997125
Citation
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.
Results Reference
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Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis
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