Study of Cytokines Serum Levels in Chronic Low Back Pain

Interleukines Clinical Trial

— cytokine  

Official title:

Analytical Transversal Study of Cytokines Serum Levels in Chronic Low Back Pain Due to Herniated Disk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991042
• Other study ID #: cytokine
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2009
• Last updated: October 6, 2009
• Start date: August 2003
• Est. completion date: March 2005

Study information

• Verified date: October 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2005
• Est. primary completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Back Pain
• Interleukines
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal da Bahia	Salvador	Bahia

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cytokines levels in patients with chronic low back pain and in healthy subjects		30 days after collect	No