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Effectiveness of Thoracic Facet Joint Nerve Blocks
This study is currently recruiting participants.
Study NCT00355706   Information provided by Pain Management Center of Paducah
First Received: July 24, 2006   No Changes Posted

July 24, 2006
July 24, 2006
August 2003
 
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.
Same as current
No Changes Posted
To assess adverse events in all patients
Same as current
 
Effectiveness of Thoracic Facet Joint Nerve Blocks
Effectiveness of Thoracic Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation
  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
 
 
Interventional
Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
Low Back Pain
Procedure: Thoracic facet joint nerve blocks
 
Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Effectiveness of thoracic medial branch blocks in managing chronic pain: a preliminary report of a randomized, double-blind controlled trial. Pain Physician. 2008 Jul-Aug;11(4):491-504.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
July 2006
 

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

Both
18 Years and older
No
Contact: Laxmaiah Manchikanti, MD 270-554-8373 ext 111 drm@thepainmd.com
United States
 
NCT00355706
 
protocol 5
Pain Management Center of Paducah
 
Principal Investigator: Laxmaiah Manchikanti, MD Ambulatory Surgery Center
Pain Management Center of Paducah
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP