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Treatment of Chronic Thoracic and Neck and Upper Extremity Pain

Information source: Pain Management Center of Paducah
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Back Pain; Neck Pain

Intervention: Xylocaine (Drug); Xylocaine and Celestone (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Pain Management Center of Paducah

Official(s) and/or principal investigator(s):
Laxmaiah Manchikanti, MD, Principal Investigator, Affiliation: Ambulatory Surgery Center, Paducah

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: To demonstrate clinically significant improvements or lack thereof with the interlaminar epidural patients with or without steroids

Secondary outcome:

To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.

To evaluate and compare the adverse event profile in all patients.

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 Non-responsive patients may be unblinded and withdrawn from the study at any time.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Ambulatory Surgery Center, Paducah, Kentucky 42001, United States
Additional Information

Starting date: February 2008
Last updated: June 20, 2013

Page last updated: August 23, 2015

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