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

This study has been completed.
Sponsor:
Collaborator:
Federal University of Bahia
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00991042
First received: October 6, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Durval Campos Kraychete, Universidade Federal da Bahia
ClinicalTrials.gov Identifier: NCT00991042     History of Changes
Other Study ID Numbers: cytokine
Study First Received: October 6, 2009
Last Updated: October 6, 2009
Health Authority: Brazil: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013