Study of Cytokines Serum Levels in Chronic Low Back Pain

NCT ID: NCT00991042

Last Updated: 2009-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2005-03-31

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.

Conditions

Interleukines

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

blood collect

Intervention Type: OTHER

Five milliliters of venous blood was drawn in the morning from subjects and immediately centrifuged.

Interventions

blood collect

Five milliliters of venous blood was drawn in the morning from subjects and immediately centrifuged.

Intervention Type: OTHER

Other Intervention Names

serum levels

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Bahia

OTHER

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Universidade Federal da Bahia

Principal Investigators

Durval C Kraychet

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

Locations

Universidade Federal da Bahia

Salvador, Estado de Bahia, Brazil

Countries

Brazil

Other Identifiers

cytokine

Identifier Type: -

Identifier Source: org_study_id