Effectiveness of Cervical Facet Joint Nerve Blocks

NCT00332722 | Completed Results DMC

• 1 other identifier: Protocol4
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To demonstrate whether:
2. 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. 3.To determine the adverse event profile in both groups.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS)

  Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable.

  over 2 years

Secondary Outcomes (1)

• Neck Disability Index (NDI)

  2 years

Study Arms (2)

Group 1- without steroid

ACTIVE COMPARATOR

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

Group 2 - with steroid

ACTIVE COMPARATOR

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

Interventions

Cervical facet joint nerve blocks PROCEDURE

Group 1- without steroid; Group 2 - with steroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pain Management Center of Paducah: lead

Study Sites (1)

Ambulatory Surgery Center

Paducah, Kentucky, 42003, United States

Location

Related Publications (1)

• 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.

  PMID: 20859313 RESULT

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study limitations include the lack of a placebo group.

Results Point of Contact

• Title: Dr. Laxmaiah Manchikanti, MD
• Organization: Pain Management Center of Paducah

drlm@thepainmd.com

2705548373

Study Officials

• Laxmaiah Manchikanti, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: C.E.O

Study Record Dates

• First Submitted: May 31, 2006
• First Posted: June 2, 2006
• Study Start: September 1, 2003
• Primary Completion: January 1, 2007
• Study Completion: March 1, 2007
• Last Updated: October 1, 2013
• Results First Posted: October 1, 2013

Record last verified: 2013-09

Locations

US (1)