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


Phase 1
20 Years
65 Years
Not Enrolling
Both
Interleukines

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

30 days after collect

Safety Issue:

No

Principal Investigator

Durval C Kraychet

Investigator Role:

Principal Investigator

Investigator Affiliation:

Federal University of Bahia

Authority:

Brazil: Ministry of Health

Study ID:

cytokine

NCT ID:

NCT00991042

Start Date:

August 2003

Completion Date:

March 2005

Related Keywords:

  • Interleukines
  • Cytokines
  • Low back pain
  • Intervertebral disk displacement
  • Interleukins
  • Tumor necrosis factor-alpha
  • Back Pain
  • Low Back Pain

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