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Effectiveness of Thoracic Facet Joint Nerve Blocks
This study is currently recruiting participants.
Verified by Pain Management Center of Paducah, July 2006
Sponsored by: Pain Management Center of Paducah
Information provided by: Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00355706
  Purpose
  1. To demonstrate whether:

    i. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect.

    ii. Addition of Depo-steroid provides additional relief of thoracic facet joint pain when used with facet joint nerve blocks.

  2. To demonstrate whether or not there are clinically significant improvements in function of patients who receive thoracic facet joint nerve block with Depo-steroid compared to patients randomized to Group I who receive only local anesthetic blocks.
  3. To determine the adverse event profile in both groups

Condition Intervention
Low Back Pain
Procedure: Thoracic facet joint nerve blocks

MedlinePlus related topics: Back Pain
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title: Effectiveness of Thoracic Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation

Further study details as provided by Pain Management Center of Paducah:

Primary Outcome Measures:
  • To demonstrate a clinically significant difference between the patients treated with Depo-steroid and those patients randomized to Group I in the pain status, physical, and psychological status and pain at 3, 6, 12, 18 and 24 months post treatment.

Secondary Outcome Measures:
  • To assess adverse events in all patients

Estimated Enrollment: 200
Study Start Date: August 2003
Estimated Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Positive for facet joint pain with comparative local anesthetic blocks

Candidates are over 18 years of age

Subjects with a history of chronic, function limiting neck pain of at least six 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 Investigator, 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 The subject has not had recent surgical procedures within the last three months.

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Exclusion Criteria:

  • Negative or false-positive response to controlled comparative local anesthetic blocks

Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 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 intercranial pressure, pseudotumor cerebri, intercranial 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 hip osteoarthritis, will not be amenable to study 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355706

Contacts
Contact: Laxmaiah Manchikanti, MD 270-554-8373 ext 111 drm@thepainmd.com

Locations
United States, Kentucky
Ambulatory Surgery Center Recruiting
Paducah, Kentucky, United States, 42003
Sponsors and Collaborators
Pain Management Center of Paducah
Investigators
Principal Investigator: Laxmaiah Manchikanti, MD Ambulatory Surgery Center
  More Information

Publications indexed to this study:
Study ID Numbers: protocol 5
Study First Received: July 24, 2006
Last Updated: July 24, 2006
ClinicalTrials.gov Identifier: NCT00355706  
Health Authority: United States: Institutional Review Board

Keywords provided by Pain Management Center of Paducah:
chronic low back pain
thoracic facet joint
nerve block

Study placed in the following topic categories:
Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009