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

Federal University of São Paulo

Status and phase: Completed; Phase 1

Conditions: Interleukines

Treatments: Other: blood collect

Study type: Interventional

Funder types: Other

Identifiers

NCT00991042

cytokine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

cytokine levels

Other group

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

Treatment:

Other: blood collect