NCT04897620

Brief 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 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".

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2021

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

1 month

First QC Date

May 18, 2021

Last Update Submit

May 18, 2021

Conditions

Outcome Measures

Primary Outcomes (8)

  • Erythrocyte sedimentation rate

    The erythrocyte sedimentation rate value in blood tests at admission examinations.

    1 month

  • C reactive protein

    The C reactive protein value in blood tests at admission examinations.

    1 month

  • Red blood cell distribution width

    The red blood cell distribution width value in blood tests at admission examinations.

    1 month

  • Mean platelet volume

    The mean platelet volume value in blood tests at admission examinations.

    1 month

  • Neutrophils to lymphocytes ratio (NLR)

    NLR is calculated by dividing the number of neutrophils by the number of lymphocytes.

    1 month

  • Platelets to lymphocytes ratio (PLR)

    PLR is calculated by dividing the number of platelets by the number of lymphocytes.

    1 month

  • Eosinophils to lymphocytes ratio (ELR)

    ELR is calculated by dividing the number of eosinophils by the number of lymphocytes.

    1 month

  • Systemic immune inflammation index (SII)

    SII is calculated by the formula "platelet numberxneutrophil number/lymphocyte number.

    1 month

Interventions

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"

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University

Ankara, Çankaya, 06520, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Elzem Bolkan Günaydın

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 21, 2021

Study Start

May 5, 2021

Primary Completion

June 5, 2021

Study Completion

June 5, 2021

Last Updated

May 21, 2021

Record last verified: 2021-05

Locations