Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis

NCT01986465 | Completed Phase 2

• 1 other identifier: 387278
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis

Keywords

lateral epicondylitis; treatment; steroid; immobilization

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Depomedrol

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Depomedrol DRUG

Depomedrol

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 to 65 years
• confirmed lateral epicondylitis
• had not received any treatment prior to enrolment

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Kashani University Hospital

Isfahan, Isfahan, Iran

Location

Related 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.

  PMID: 23997125 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Mohamad A Tahririan, MD

  Isfahan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 18, 2013

Record last verified: 2013-11

Locations

IR (1)