NCT01071369

Treatment of Chronic Thoracic and Neck and Upper Extremity Pain

A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Cervical and Thoracic Interlaminar Epidural Injections in Thoracic and Cervical Disc Herniation, Discogenic Pain, and Post-Cervical Laminectomy Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Pain Management Center of Paducah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To study improvements or lack thereof with the interlaminar epidural patients with or without steroids experiences mid back, upper back or neck pain with or without chest wall and upper extremity pain of at least 6-months duration non-responsive to conservative management.

Detailed description

This is a Single-center, prospective, controlled, double-blind, randomized study in thoracic and cervical regions. Patients are studied in 2 groups in each region. * Group I-local anesthetic only. * Group II-local anesthetic with 6 mg of non-particulate Celestone. All patients will be unblinded at 12 or 24 months. Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group, if patient consents. Non-responsive patients may be unblinded and withdrawn from the study at any time.

Conditions

• Back Pain
• Neck Pain

Interventions

Type	Name	Description
DRUG	Xylocaine	0.5% Xylocaine
DRUG	Xylocaine and Celestone	non-particulate Celestone

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-02-01
• Completion: 2012-06-01
• First posted: 2010-02-19
• Last updated: 2017-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study