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Effectiveness of Cervical Facet Joint Nerve Blocks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00332722
Recruitment Status : Completed
First Posted : June 2, 2006
Results First Posted : October 1, 2013
Last Update Posted : October 1, 2013
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah

Brief Summary:
  1. To demonstrate whether:

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

    ii. Adjuvant medications (Sarapin and Depo-Medrol) provide additional relief of cervical 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 cervical facet joint nerve block with or without Sarapin and Depo-Medrol (Group II) compared to patients randomized to Group I who receive only local anesthetic blocks.
  3. To determine the adverse event profile in both groups.

Condition or disease Intervention/treatment Phase
Neck Pain Procedure: Cervical facet joint nerve blocks Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Cervical Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation
Study Start Date : September 2003
Actual Primary Completion Date : January 2007
Actual Study Completion Date : March 2007

Arm Intervention/treatment
Active Comparator: Group 1- without steroid
Cervical Facet Joint Nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
Procedure: Cervical facet joint nerve blocks
Active Comparator: Group 2 - with steroid
Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
Procedure: Cervical facet joint nerve blocks

Primary Outcome Measures :
  1. Numeric Rating Scale (NRS) [ Time Frame: over 2 years ]
    Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable.

Secondary Outcome Measures :
  1. Neck Disability Index (NDI) [ Time Frame: 2 years ]
    Neck Disability Index (range 0-50) is represented as 0-4 no disability, 5-14 mild disability, 15 - 24 moderate disability, 25 - 34 severe disability and >34 (35-50) complete disability.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00332722

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

Publications of Results:
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Responsible Party: Laxmaiah Manchikanti, MD, C.E.O, Pain Management Center of Paducah Identifier: NCT00332722    
Other Study ID Numbers: Protocol4
First Posted: June 2, 2006    Key Record Dates
Results First Posted: October 1, 2013
Last Update Posted: October 1, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Neck Pain
Neurologic Manifestations
Signs and Symptoms