COMPARISON OF SYSTEMIC INFLAMMATION-RELATED HEMATOLOGICAL PARAMETERS IN ACUTE AND CHRONIC LOW BACK PAIN

May 18, 2021 updated by: Elzem Bolkan Günaydın, Ufuk University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06520
        • Recruiting
        • Ufuk University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erythrocyte sedimentation rate
Time Frame: 1 month
The erythrocyte sedimentation rate value in blood tests at admission examinations.
1 month
C reactive protein
Time Frame: 1 month
The C reactive protein value in blood tests at admission examinations.
1 month
Red blood cell distribution width
Time Frame: 1 month
The red blood cell distribution width value in blood tests at admission examinations.
1 month
Mean platelet volume
Time Frame: 1 month
The mean platelet volume value in blood tests at admission examinations.
1 month
Neutrophils to lymphocytes ratio (NLR)
Time Frame: 1 month
NLR is calculated by dividing the number of neutrophils by the number of lymphocytes.
1 month
Platelets to lymphocytes ratio (PLR)
Time Frame: 1 month
PLR is calculated by dividing the number of platelets by the number of lymphocytes.
1 month
Eosinophils to lymphocytes ratio (ELR)
Time Frame: 1 month
ELR is calculated by dividing the number of eosinophils by the number of lymphocytes.
1 month
Systemic immune inflammation index (SII)
Time Frame: 1 month
SII is calculated by the formula "platelet numberxneutrophil number/lymphocyte number.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ufuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Anticipated)

June 5, 2021

Study Completion (Anticipated)

June 5, 2021

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-06-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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