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

Primary Purpose

Interleukines

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
blood collect
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Interleukines focused on measuring Cytokines, Low back pain, Intervertebral disk displacement, Interleukins, Tumor necrosis factor-alpha

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Federal da Bahia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

cytokine levels

Arm Description

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

Outcomes

Primary Outcome Measures

cytokines levels in patients with chronic low back pain and in healthy subjects

Secondary Outcome Measures

Full Information

First Posted
October 6, 2009
Last Updated
October 6, 2009
Sponsor
Federal University of São Paulo
Collaborators
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT00991042
Brief Title
Study of Cytokines Serum Levels in Chronic Low Back Pain
Acronym
cytokine
Official Title
Analytical Transversal Study of Cytokines Serum Levels in Chronic Low Back Pain Due to Herniated Disk
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo
Collaborators
Federal University of Bahia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interleukines
Keywords
Cytokines, Low back pain, Intervertebral disk displacement, Interleukins, Tumor necrosis factor-alpha

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cytokine levels
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
blood collect
Other Intervention Name(s)
serum levels
Intervention Description
Five milliliters of venous blood was drawn in the morning from subjects and immediately centrifuged.
Primary Outcome Measure Information:
Title
cytokines levels in patients with chronic low back pain and in healthy subjects
Time Frame
30 days after collect

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Durval C Kraychet
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal da Bahia
City
Salvador
State/Province
Bahia
Country
Brazil

12. IPD Sharing Statement

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Study of Cytokines Serum Levels in Chronic Low Back Pain

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