NCT00554476

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
Last Updated

November 7, 2007

Status Verified

November 1, 2007

First QC Date

November 5, 2007

Last Update Submit

November 5, 2007

Conditions

Lateral Epicondylitis

Keywords

Lateral EpicondylitisTreatmentCorticosteroidElbow CastIcingNSAIDs

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale (VAS)

Secondary Outcomes (1)

  • Patient's satisfaction

Interventions

Triamcinolone Acetonide- Indomethacin-Cryotherapy-CastingDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azad University of Medical Sciences, Boo-Ali Hospital

Tehran, Tehran Province, 13456/7889, Iran

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Jaleh Hassanloo, MD

    Department of Orthopedics, Boo-Ali Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 7, 2007

Study Start

January 1, 2003

Study Completion

April 1, 2006

Last Updated

November 7, 2007

Record last verified: 2007-11

Locations

IR(1)