Trial | NCT01071369  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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.
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 Non-responsive patients may be unblinded and withdrawn from the study at any time.
Study Started
Feb 29
2008
Primary Completion
Feb 29
2008
Study Completion
Jun 30
2012
Last Update
Apr 27
2017

Drug Xylocaine

0.5% Xylocaine

Drug Xylocaine and Celestone

non-particulate Celestone

  • Other names: Celestone

Xylocaine Active Comparator

0.5% Xylocaine

Xylocaine and Celestone Active Comparator

0.5% Xylocaine with 6 mg of non-particulate Celestone.

Criteria 

Inclusion Criteria:

Subjects of at least 18 years of age
Subjects with a history of chronic, function-limiting thoracic or cervical pain with or without upper extremity pain of at least 6 months in duration
Subjects who are able to give voluntary, written informed consent to participate in this investigation
Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
Subjects have not had recent surgical procedures within the last 3 months.

Exclusion Criteria:

Compressive radiculopathy
Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
Uncontrolled major depression or uncontrolled psychiatric disorders
Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease
Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function
Women who are pregnant or lactating
Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
Patients with multiple complaints involving concomitant shoulder osteoarthritis, due to the overlap of pain complaints
Inability to achieve appropriate positioning and inability to understand informed consent and protocol
History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers.
No Results Posted