NCT00554476TerminatedPhase 4
Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial
Azad University of Medical Sciences2 sites in 2 countries50 target enrollmentStarted: January 1, 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- visual analogue scale (VAS)
Study Overview
Brief Summary
To compare the effectiveness of two combined therapeutic methods including corticosteroid injections with elbow cast versus ice massage and non-steroidal anti inflammatory drugs (NSAIDs).
Detailed Description
Design: Randomized clinical trial. Setting: Boo-Ali and Baqyiatallah Hospital in Tehran. Patients: 50 randomly selected patients, in two groups of 25 subjects. Interventions: Corticosteroid injections with elbow cast versus icing and NSAIDs.
Outcome measures: Patients were evaluated for outcomes, complications and patients' satisfaction at 2nd, 4th, and 12th week after beginning of treatment. We measured the pain severity by Visual Analogue Scale (VAS).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pain at the lateral side of the elbow
- •pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension, or resisted extension of middle finger at the metacarpophalangeal joint
- •pain to be continued for longer than 6 weeks or even with recurrent pain during similar period
Exclusion Criteria
- •previous history of receiving any treatment for lateral epicondylitis within 6 months prior to intervention
- •patients who were unable to return for follow up
- •patients with nerve entrapment
- •pregnancy
- •breast-feeding
- •presence of systemic neuromuscular disorders such as myasthenia gravis
- •upper limb fractures
- •other arm/forearm pathology such as radial nerve compression
- •known thrombocytopenia
- •coagulopathy or bleeding diathesis
- •history of diffuse pain syndrome
- •history of inflammatory arthropathy
- •intolerance/allergy to corticosteroids or NSAIDs or any contraindication for these
- •untreated depression
- •history of narcotic use for pain management greater than 1 month or history of narcotic abuse problem
Outcomes
Primary Outcomes
visual analogue scale (VAS)
Secondary Outcomes
- Patient's satisfaction
Investigators
Study Sites (2)
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