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Completed

NCT Number: NCT00991042

Study of Cytokines Serum Levels in Chronic Low Back Pain

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.

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Key information

Conditions

Interleukines Back Pain Bone Diseases Hernia Intervertebral Disc Displacement Low Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universidade Federal da Bahia

Salvador, Estado de Bahia, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood collect

Other

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

Other names: serum levels

Primary outcomes

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

    Time frame: 30 days after collect

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Federal University of Bahia

Registry information

Official study title

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

Acronym: cytokine

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Oct 7, 2009
Registry last updated
Oct 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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