Effectiveness of Cervical Facet Joint Nerve Blocks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier:
NCT00332722
First received: May 31, 2006
Last updated: September 27, 2013
Last verified: September 2013

May 31, 2006
September 27, 2013
September 2003
January 2007   (final data collection date for primary outcome measure)
Numeric Rating Scale (NRS) [ Time Frame: over 2 years ] [ Designated as safety issue: No ]
Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable.
To demonstrate a clinically significant difference between the patients treated with adjuvants and those patients randomized to Group I in the pain status, physical, and psychological status and pain at 3, 6, 12, 18and 24 months post treatment;
Complete list of historical versions of study NCT00332722 on ClinicalTrials.gov Archive Site
Neck Disability Index (NDI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
To assess adverse events in all patients.
Not Provided
Not Provided
 
Effectiveness of Cervical Facet Joint Nerve Blocks
Effectiveness of Cervical 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. 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Neck Pain
Procedure: Cervical facet joint nerve blocks
Other Name: Cervical Facet Joint Nerve Blocks
  • 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)
    Intervention: 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)
    Intervention: Procedure: Cervical facet joint nerve blocks
Manchikanti L, Singh V, Falco FJ, Cash KA, Fellows B. Comparative outcomes of a 2-year follow-up of cervical medial branch blocks in management of chronic neck pain: a randomized, double-blind controlled trial. Pain Physician. 2010 Sep-Oct;13(5):437-50.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2007
January 2007   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00332722
Protocol4
Yes
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
Pain Management Center of Paducah
Not Provided
Principal Investigator: Laxmaiah Manchikanti, MD
Pain Management Center of Paducah
September 2013

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