Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis

Sponsor

Azad University of Medical Sciences (Other)

Overall Status

Terminated

CT.gov ID

NCT00554476

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lateral Epicondylitis	Drug: Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting	Phase 4

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 Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial

Study Start Date :

Jan 1, 2003

Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

visual analogue scale (VAS) []

Secondary Outcome Measures

Patient's satisfaction []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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