Effectiveness of Lumbar Facet Joint Nerve Blocks - Full Text View

Sponsored by:	Pain Management Center of Paducah
Information provided by:	Pain Management Center of Paducah
ClinicalTrials.gov Identifier:	NCT00355914

Purpose

To demonstrate whether:

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

ii. Adjuvant medications (Sarapin and Depo-steroids) provide additional relief of lumbar facet joint pain when used with facet joint nerve blocks.
To demonstrate whether or not there are clinically significant improvements in function of patients who receive lumbar facet joint nerve block with or without Sarapin and Depo-steroids (Group II) compared to patients randomized to Group I who receive only local anesthetic blocks.
To determine the adverse event profile in both groups.

Condition	Intervention
Low Back Pain	Procedure: Lumbar Facet Joint Nerve Block

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Facet Joint Nerve Blocks

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

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 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;

Secondary Outcome Measures:

To assess adverse events in all patients

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

Detailed Description:

Primary Outcome Measure(s) 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;

Secondary Outcome Measure(s) To assess adverse events in all patients.

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 low back 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355914

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
Principal Investigator: Laxmaiah Manchikanti, MD

Sponsors and Collaborators

Pain Management Center of Paducah

Investigators

Principal Investigator:

Laxmaiah Manchikanti, MD

Ambulatory Surgery Center

More Information

No publications provided by Pain Management Center of Paducah

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Lumbar facet joint nerve blocks in managing chronic facet joint pain: one-year follow-up of a randomized, double-blind controlled trial: Clinical Trial NCT00355914. Pain Physician. 2008 Mar-Apr;11(2):121-32.

Manchikanti L, Manchikanti KN, Manchukonda R, Cash KA, Damron KS, Pampati V, McManus CD. Evaluation of lumbar facet joint nerve blocks in the management of chronic low back pain: preliminary report of a randomized, double-blind controlled trial: clinical trial NCT00355914. Pain Physician. 2007 May;10(3):425-40.

Study ID Numbers:	protocol3
Study First Received:	July 24, 2006
Last Updated:	August 23, 2006
ClinicalTrials.gov Identifier:	NCT00355914 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Pain Management Center of Paducah:

Lumbar 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:

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

ClinicalTrials.gov processed this record on July 02, 2009