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Study of Cytokines Serum Levels in Chronic Low Back Pain (cytokine)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991042
First Posted: October 7, 2009
Last Update Posted: October 7, 2009
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.
Collaborator:
Federal University of Bahia
Information provided by:
Federal University of São Paulo
  Purpose

The purpose of this study is to:

  • evaluate if there is an association between elevated levels of cytokines and chronic pain due to herniated disk disease
  • measured cytokines levels in chronic low back pain and in healthy subjects.

Condition Intervention Phase
Interleukines Other: blood collect Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Analytical Transversal Study of Cytokines Serum Levels in Chronic Low Back Pain Due to Herniated Disk

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • cytokines levels in patients with chronic low back pain and in healthy subjects [ Time Frame: 30 days after collect ]

Enrollment: 23
Study Start Date: August 2003
Study Completion Date: March 2005
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
cytokine levels
Serum levels of pro-inflammatory cytokines were measured using the Enzyme Linked Immuno Sorbent Assay (ELISA) technique in 23 patients with pain due to herniated disk disease (G1) as well as in 10 control healthy subject
Other: blood collect
Five milliliters of venous blood was drawn in the morning from subjects and immediately centrifuged.
Other Name: serum levels

Detailed Description:

23 patients with at least three months of back pain due to herniated disk disease were selected Diagnosis was confirmed by magnetic resonance imaging (MRI) or computerized tomography (CT) imaging of the spine for all patients. In addition, pain severity had to be ³ 5 points on the Numerical Rating Scale (NRS) ranging from zero (no pain) to 10 (worst imaginable pain).

The exclusion criteria were defined as one or more of the following: psychiatric disorders, systemic or inflammatory disease, history of allergy, presence of motor deficits, history of blood dyscrasia, pregnancy, active infection, tumor, use of analgesic drugs in the week before or inability to come to the hospital for evaluation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 23 patients

    • least three months of back pain due to herniated disk disease
    • pain severity had to be 5 points on the Numerical Rating Scale (NRS)
  • 10 healthy volunteers:

    • without previous history of back pain

Exclusion Criteria:

  • One or more of the following:

    • psychiatric disorders
    • systemic or inflammatory disease
    • history of allergy
    • presence of motor deficits
    • history of blood dyscrasia
    • pregnancy
    • active infection, tumor
    • use of analgesic drugs in the week before
    • inability to come to the hospital for evaluation.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00991042


Locations
Brazil
Universidade Federal da Bahia
Salvador, Bahia, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Federal University of Bahia
Investigators
Principal Investigator: Durval C Kraychet Federal University of Bahia
  More Information

Responsible Party: Durval Campos Kraychete, Universidade Federal da Bahia
ClinicalTrials.gov Identifier: NCT00991042     History of Changes
Other Study ID Numbers: cytokine
First Submitted: October 6, 2009
First Posted: October 7, 2009
Last Update Posted: October 7, 2009
Last Verified: October 2009

Keywords provided by Federal University of São Paulo:
Cytokines
Low back pain
Intervertebral disk displacement
Interleukins
Tumor necrosis factor-alpha

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms


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