Study of Cytokines Serum Levels in Chronic Low Back Pain

Phase 1

Completed

• Conditions: Interleukines
• Interventions: Other: blood collect

• Registration Number: NCT00991042
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2004-09
• Study Completion: 2005-03
• Status Verified: 2009-10
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-06
• Last Update Submitted: 2009-10-06
• Study First Posted: 2009-10-07
• Last Update Posted: 2009-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cytokine levels	blood collect	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

Primary Outcome Measures

Name	Time	Method
cytokines levels in patients with chronic low back pain and in healthy subjects	30 days after collect

Trial Locations

Locations (1)

Universidade Federal da Bahia; 🇧🇷 Salvador, Bahia, Brazil