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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00554476
Other study ID # RCT-246910-06
Secondary ID
Status Terminated
Phase Phase 4
First received November 5, 2007
Last updated November 5, 2007
Start date January 2003
Est. completion date April 2006

Study information

Verified date November 2007
Source Azad University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Terminated
Enrollment 50
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting


Locations

Country Name City State
Iran, Islamic Republic of Azad University of Medical Sciences, Boo-Ali Hospital Tehran

Sponsors (1)

Lead Sponsor Collaborator
Azad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary visual analogue scale (VAS)
Secondary Patient's satisfaction
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