Pain, ChronicNCT04897620
COMPARISON OF SYSTEMIC INFLAMMATION-RELATED HEMATOLOGICAL PARAMETERS IN ACUTE AND CHRONIC LOW BACK PAIN
An observational study of Pain, Chronic, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare the neutrophils to lymphocytes ratio (NLR), platelets to lymphocytes ratio (PLR), eosinophils to lymphocytes ratio (ELR), red blood cell distribution width (RDW), mean platelet volume (MPV), systemic immune inflammation index (SII), erythrocyte sedimentation rate (ESR) and C reactive… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Scanning the blood test results
- How many people
- 450 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2021to 5 Jun 2021
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: The data of patients between the ages of 18-65 who applied to the emergency department with the complaint of acute (less than 4 weeks) low back pain or to the Physical Medicine and Rehabilitation outpatient clinic with the complaint of subacute (lasting 4-12 weeks) or chronic (longer than 12 weeks) non-specific low back pain in the last 3 years will be scanned. The data of patients who applied with complaints other than medical conditions known to be associated with painful conditions and/or inflammatory response will be screened as a control group.
Who may be able to join
- The data of patients who applied to the emergency department with the complaint of acute (less than 4 weeks) low back pain or to the Physical Medicine and Rehabilitation outpatient clinic with the complaint of subacute (lasting 4-12 weeks) or chronic (longer than 12 weeks) non-specific low back pain in the last 3 years.
- The data of patients between the ages of 18-65.
Who cannot join
- Patients who have systemic diseases or internal organ pathologies that may cause low back pain, acute/chronic infection, malignancy, rheumatic disease or systemic diseases that may change the hematological inflammation parameters, which are evaluation parameters,
- Patients who have severe neurological involvement findings in imaging examinations or clinical examination,
- Patients who have a history of surgical procedures for the lumbar region in the last 6 months
- Patients those missing one or more of the parameters planned to be evaluated within the scope of the screened data.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ufuk University
Ankara, Çankaya, 06520
elzem bolkan günaydın, +905309787303, elzembolkan@yahoo.com
About this study
The aim of the study is to compare the neutrophils to lymphocytes ratio (NLR), platelets to lymphocytes ratio (PLR), eosinophils to lymphocytes ratio (ELR), red blood cell distribution width (RDW), mean platelet volume (MPV), systemic immune inflammation index (SII), erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) which are the hematological parameters associated with systemic inflammation in acute and subacute/chronic low back pain. Secondary purpose; evaluation of the prognostic roles of hematological parameters associated with systemic inflammation in low back pain in predicting chronicity.This study is a retrospective case-control study. The data of patients who applied to the emergency department with the complaint of acute (less than 4 weeks) low back pain or to the Physical Medicine and Rehabilitation outpatient clinic with the complaint of subacute (lasting 4-12 weeks) or chronic (longer than 12 weeks) non-specific low back pain in the last 3 years will be scanned. The data of patients who applied with complaints other than medical conditions known to be associated with painful conditions and/or inflammatory response will be screened as a control group. The data of patients between the ages of 18-65 will be included in the study. In conclusion, the data of 150 patients who presented with acute non-specific low back pain, 150 patients who presented with subacute/chronic non-specific low back pain and 150 participants as the control group will be included in the study for use in analysis. Participants' age, gender, duration of low back pain (days), if evaluated, conditions associated with low back pain in cases with subacute/chronic pain, ESR, CRP, RDW, MPV, neutrophil count, lymphocyte count, eosinophil count and platelet count in blood tests at admission examinations will be recorded. NLR will be calculated by dividing the number of neutrophils by the number of lymphocytes, PLR by dividing the number of platelets by the number of lymphocytes, ELR by dividing the number of eosinophils by the number of lymphocytes, and SII by the formula "platelet numberxneutrophil number/lymphocyte number".
- Conditions
- Pain, Chronic
- Being tested
- Scanning the blood test results
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scanning the blood test resultsOther
Participants' age, gender, duration of low back pain (days), if evaluated, conditions associated with low back pain in cases with subacute/chronic pain, ESR, CRP, RDW, MPV, neutrophil count, lymphocyte count, eosinophil count and platelet count in blood tests at admission examinations were recorded. NLR was calculated by dividing the number of neutrophils by the number of lymphocytes, PLR by dividing the number of platelets by the number of lymphocytes, ELR by dividing the number of eosinophils by the number of lymphocytes, and SII by the formula "platelet numberxneutrophil number/lymphocyte number"
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythrocyte sedimentation rate
The erythrocyte sedimentation rate value in blood tests at admission examinations.
Measured: 1 month
C reactive protein
The C reactive protein value in blood tests at admission examinations.
Measured: 1 month
Red blood cell distribution width
The red blood cell distribution width value in blood tests at admission examinations.
Measured: 1 month
Mean platelet volume
The mean platelet volume value in blood tests at admission examinations.
Measured: 1 month
Neutrophils to lymphocytes ratio (NLR)
NLR is calculated by dividing the number of neutrophils by the number of lymphocytes.
Measured: 1 month
Platelets to lymphocytes ratio (PLR)
PLR is calculated by dividing the number of platelets by the number of lymphocytes.
Measured: 1 month
Eosinophils to lymphocytes ratio (ELR)
ELR is calculated by dividing the number of eosinophils by the number of lymphocytes.
Measured: 1 month
Systemic immune inflammation index (SII)
SII is calculated by the formula "platelet numberxneutrophil number/lymphocyte number.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start5 May 2021
- Primary completion5 Jun 2021 (estimated)
- Study completion5 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem Bolkan Günaydın, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897620
- Sponsor's protocol ID
- 2021-06-10
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF SYSTEMIC INFLAMMATION-RELATED HEMATOLOGICAL PARAMETERS IN ACUTE AND CHRONIC LOW BACK PAIN
- ClinicalTrials.gov ID
- NCT04897620
- Acronym / sponsor ID
- 2021-06-10
- Conditions
- Pain, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 5 Jun 2021 (estimated)
- Study completion
- 5 Jun 2021 (estimated)
- First posted
- 21 May 2021 (actual)
- 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 aim of the study is to compare the neutrophils to lymphocytes ratio (NLR), platelets to lymphocytes ratio (PLR), eosinophils to lymphocytes ratio (ELR), red blood cell distribution width (RDW), mean platelet volume (MPV), systemic immune inflammation index (SII), erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) which are the hematological parameters associated with systemic inflammation in acute and subacute/chronic low back pain. Secondary purpose; evaluation of the prognostic roles of hematological parameters associated with systemic inflammation in low back pain in predicting chronicity.This study is a retrospective case-control study. The data of patients who applied to the emergency department with the complaint of acute (less than 4 weeks) low back pain or to the Physical Medicine and Rehabilitation outpatient clinic with the complaint of subacute (lasting 4-12 weeks) or chronic (longer than 12 weeks) non-specific low back pain in the last 3 years will be scanned. The data of patients who applied with complaints other than medical conditions known to be associated with painful conditions and/or inflammatory response will be screened as a control group. The data of patients between the ages of 18-65 will be included in the study. In conclusion, the data of 150 patients who presented with acute non-specific low back pain, 150 patients who presented with subacute/chronic non-specific low back pain and 150 participants as the control group will be included in the study for use in analysis. Participants' age, gender, duration of low back pain (days), if evaluated, conditions associated with low back pain in cases with subacute/chronic pain, ESR, CRP, RDW, MPV, neutrophil count, lymphocyte count, eosinophil count and platelet count in blood tests at admission examinations will be recorded. NLR will be calculated by dividing the number of neutrophils by the number of lymphocytes, PLR by dividing the number of platelets by the number of lymphocytes, ELR by dividing the number of eosinophils by the number of lymphocytes, and SII by the formula "platelet numberxneutrophil number/lymphocyte number".
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The data of patients between the ages of 18-65 who applied to the emergency department with the complaint of acute (less than 4 weeks) low back pain or to the Physical Medicine and Rehabilitation outpatient clinic with the complaint of subacute (lasting 4-12 weeks) or chronic (longer than 12 weeks) non-specific low back pain in the last 3 years will be scanned. The data of patients who applied with complaints other than medical conditions known to be associated with painful conditions and/or inflammatory response will be screened as a control group.
Key inclusion criteria (2 listed)
- The data of patients who applied to the emergency department with the complaint of acute (less than 4 weeks) low back pain or to the Physical Medicine and Rehabilitation outpatient clinic with the complaint of subacute (lasting 4-12 weeks) or chronic (longer than 12 weeks) non-specific low back pain in the last 3 years.
- The data of patients between the ages of 18-65.
Key exclusion criteria (4 listed)
- Patients who have systemic diseases or internal organ pathologies that may cause low back pain, acute/chronic infection, malignancy, rheumatic disease or systemic diseases that may change the hematological inflammation parameters, which are evaluation parameters,
- Patients who have severe neurological involvement findings in imaging examinations or clinical examination,
- Patients who have a history of surgical procedures for the lumbar region in the last 6 months
- Patients those missing one or more of the parameters planned to be evaluated within the scope of the screened data.
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 |
|---|---|---|
| Scanning the blood test resultsParticipants' age, gender, duration of low back pain (days), if evaluated, conditions associated with low back pain in cases with subacute/chronic pain, ESR, CRP, RDW, MPV, neutrophil count, lymphocyte count, eosinophil count and platelet count in blood tests at admission examinations were recorded. NLR was calculated by dividing the number of neutrophils by the number of lymphocytes, PLR by dividing the number of platelets by the number of lymphocytes, ELR by dividing the number of eosinophils by the number of lymphocytes, and SII by the formula "platelet numberxneutrophil number/lymphocyte number" | Other | – |
Primary outcome
Erythrocyte sedimentation rate
Time frame: 1 month
The erythrocyte sedimentation rate value in blood tests at admission examinations.
C reactive protein
Time frame: 1 month
The C reactive protein value in blood tests at admission examinations.
Red blood cell distribution width
Time frame: 1 month
The red blood cell distribution width value in blood tests at admission examinations.
Mean platelet volume
Time frame: 1 month
The mean platelet volume value in blood tests at admission examinations.
Neutrophils to lymphocytes ratio (NLR)
Time frame: 1 month
NLR is calculated by dividing the number of neutrophils by the number of lymphocytes.
Platelets to lymphocytes ratio (PLR)
Time frame: 1 month
PLR is calculated by dividing the number of platelets by the number of lymphocytes.
Eosinophils to lymphocytes ratio (ELR)
Time frame: 1 month
ELR is calculated by dividing the number of eosinophils by the number of lymphocytes.
Systemic immune inflammation index (SII)
Time frame: 1 month
SII is calculated by the formula "platelet numberxneutrophil number/lymphocyte number.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic, run by Ufuk University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 May 2021. 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 Turkey (Türkiye). 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elzem Bolkan Günaydın (05309787303, elzembolkan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythrocyte sedimentation rate (time frame: 1 month). The study lists 8 primary outcomes in all. 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 21 May 2021.