InterleukinesPhase 1cytokineNCT00991042
Study of Cytokines Serum Levels in Chronic Low Back Pain
A Phase 1 study testing blood collect in people with Interleukines, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Interleukines
- What is being tested?
- blood collect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2003to Mar 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- One or more of the following:
- psychiatric disorders
- systemic or inflammatory disease
- history of allergy
- presence of motor deficits
- history of blood dyscrasia
Show all 10Show fewer
- pregnancy
- active infection, tumor
- use of analgesic drugs in the week before
- inability to come to the hospital for evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analytical Transversal Study of Cytokines Serum Levels in Chronic Low Back Pain Due to Herniated Disk
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.
Read the 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.
- Conditions
- Interleukines
- Being tested
- blood collect
- Keywords
- Cytokines, Low back pain, Intervertebral disk displacement, Interleukins, Tumor necrosis factor-alpha
- Medical subject headings
- Low Back Pain, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collectOther
Also called serum levels
Five milliliters of venous blood was drawn in the morning from subjects and immediately centrifuged.
| Study group | Role | What they receive |
|---|---|---|
| cytokine levels | Other | 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 Receives: Other: blood collect |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokines levels in patients with chronic low back pain and in healthy subjects
Measured: 30 days after collect
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startAug 2003
- Primary completionSep 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterleukinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Bahia
- Investigators
- Durval C Kraychet, Principal investigator, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991042
- Sponsor's protocol ID
- cytokine
- Acronym
- cytokine
- Status last verified
- Oct 2009
- First submitted
- 6 Oct 2009
- Last updated
- 7 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytical Transversal Study of Cytokines Serum Levels in Chronic Low Back Pain Due to Herniated Disk
- ClinicalTrials.gov ID
- NCT00991042
- Acronym / sponsor ID
- cytokine / cytokine
- Conditions
- Interleukines
- Keywords
- Cytokines, Low back pain, Intervertebral disk displacement, Interleukins, Tumor necrosis factor-alpha
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Federal University of Bahia
- Study start
- Aug 2003
- Primary completion
- Sep 2004 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cytokine levels | Other | Other: blood collectSerum 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 23 patients
- 10 healthy volunteers:
Key exclusion criteria (10 listed)
- One or more of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood collectAlso: serum levelsFive milliliters of venous blood was drawn in the morning from subjects and immediately centrifuged. | Other | cytokine levels |
Primary outcome
cytokines levels in patients with chronic low back pain and in healthy subjects
Time frame: 30 days after collect
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Durval C Kraychet principal investigator
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing blood collect in people with Interleukines, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytokines levels in patients with chronic low back pain and in healthy subjects (time frame: 30 days after collect). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2009.