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Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis

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ClinicalTrials.gov Identifier: NCT01986465
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : November 18, 2013
Sponsor:
Information provided by (Responsible Party):
Amir Moayednia, Isfahan University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Drug: Depomedrol Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Effectiveness of Steroid Injection Versus Placebo and Immobilization Versus no Immobilization in Treating Patients With Lateral Epicondylitis
Study Start Date : May 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013


Arm Intervention/treatment
Experimental: 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.
Drug: Depomedrol
Placebo Comparator: 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.
Drug: Placebo



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986465


Locations
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Iran, Islamic Republic of
Kashani University Hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Principal Investigator: Mohamad A Tahririan, MD Isfahan University of Medical Sciences
Publications:
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Responsible Party: Amir Moayednia, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01986465    
Other Study ID Numbers: 387278
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: November 18, 2013
Last Verified: November 2013
Keywords provided by Amir Moayednia, Isfahan University of Medical Sciences:
lateral epicondylitis
treatment
steroid
immobilization
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents