Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain

NCT05751499 | Unknown DMC FDA Device

• 1 other identifier: Rana Muhammad Tahir
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

• To compare the diagnostic and prognostic blood markers in acute and chronic nonspecific low back pain with healthy controls

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (28)

• CRP

  It measures the level of C-reactive proteins in a sample of blood. CRP is a protein made by lever. It shows inflammation in the body

  0 weeks [at the start of data]

• CRP

  It measures the level of C-reactive proteins in a sample of blood. CRP is a protein made by lever. It shows inflammation in the body

  8th weeks

• CRP

  It measures the level of C-reactive proteins in a sample of blood. CRP is a protein made by lever. It shows inflammation in the body

  16th weeks

• CRP

  It measures the level of C-reactive proteins in a sample of blood. CRP is a protein made by lever. It shows inflammation in the body

  24th weeks

• TNF ALPHA

  TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.

  0 weeks

• TNF ALPHA

  TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.

  8 weeks

• TNF ALPHA

  TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.

  16 weeks

• TNF ALPHA

  TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.

  24 weeks

• IL 1

  Interleukin-1 is a group of 11 cytokines that plays a central role in the regulation of immune and inflammatory response to infections

  0 weeks

• IL 1

  Interleukin-1 is a group of 11 cytokines that plays a central role in the regulation of immune and inflammatory response to infections

  8 weeks

• IL 1

  Interleukin-1 is a group of 11 cytokines that plays a central role in the regulation of immune and inflammatory response to infections

  16 weeks

• IL 1

  Interleukin-1 is a group of 11 cytokines that plays a central role in the regulation of immune and inflammatory response to infections

  24 weeks

• IL 6

  Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.

  0 weeks

• IL 6

  Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.

  8 weeks

• IL 6

  Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.

  16 weeks

• IL 6

  Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.

  24 weeks

• IL-8

  Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions

  0 weeks

• IL-8

  Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions

  8 weeks

• IL-8

  Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions

  16 weeks

• IL-8

  Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions

  24 weeks

• IL-1 BETA

  IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition

  0 weeks

• IL-1 BETA

  IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition

  8 weeks

• IL-1 BETA

  IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition

  16 weeks

• IL-1 BETA

  IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition

  24 weeks

• Fibrinogen

  Fibrinogen is a protein produced by liver, its high levels may occur as a part of normal response to infection or inflammation.

  0 weeks

• Fibrinogen

  Fibrinogen is a protein produced by liver, its high levels may occur as a part of normal response to infection or inflammation.

  8 weeks

• Fibrinogen

  Fibrinogen is a protein produced by liver, its high levels may occur as a part of normal response to infection or inflammation.

  16 weeks

• Fibrinogen

  Fibrinogen is a protein produced by liver, its high levels may occur as a part of normal response to infection or inflammation.

  24 weeks

Secondary Outcomes (64)

• Numeric rating scale

  0 weeks

• Numeric rating scale

  8 weeks

• Numeric rating scale

  16 weeks

• Numeric rating scale

  24 weeks

• Low Back outcome scale

  0 weeks

Other Outcomes (8)

• Gait & Balance App:

  0 weeks

• Gait & Balance App:

  8 weeks

• Gait & Balance App:

  16 weeks

Study Arms (2)

CASE GROUP

1. Both male \& Female patients 2. Age group 18-60 Years 3. Diagnosed with nonspecific low back pain in acute/flared stage

Diagnostic Test: • Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN

CONTROL GROUP

MALE AND FEMALE AGE GROUP 18 TO 60 YEARS NOT SUFFERING FROM LOW BACK PAIN

Diagnostic Test: • Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN

Interventions

• Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN DIAGNOSTIC_TEST

* Low Back Outcome Scale * Center for Epidemiological Studies-Depression Scale (CES-D) * International Physical Activity Questionnaire * Roland-Morris Disability Questionnaire * Force Platform * Pain Self-Efficacy Questionnaire (PSEQ) * Numeric Rating Scale * Job Content Questionnaire * Pits Burgh Sleep Quality Index (PSQI) * Orebo Musculoskeletal Pain Screening Questionnaire * Gait \& Balance App * Keele STarT Back Screening Tool (SBST) * Fear-Avoidance Beliefs Questionnaire (FABQ) * Pain Catastrophizing Scale

CASE GROUP; CONTROL GROUP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

PEOPLE BETWEEN 18 TO 60 YEARS HAVING LOW BACK PAIN WITH NON SPECIFIC REASON

You may qualify if:

• Both male \& Female patients
• Age group 18-60 Years
• Diagnosed with nonspecific low back pain in acute/flared stage

You may not qualify if:

• Any serious conditions like neurological conditions
• Any infection
• Tumor
• Spinal Surgery
• Cognitive Impairments
• Refusal to sign consent
• patients taking any type of psychological management or rheumatologic disease would be excluded

Sponsors & Collaborators

• Riphah International University: lead
• KRL Hospital, Islamabad: collaborator

Study Sites (1)

KRL Hospital

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Waqar A Awan, PhD

  Faculty of Rehabilitation & Allied Health Sciences, Riphah International University

  STUDY DIRECTOR

• IMRAN AMJAD, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana M Tahir, PhD*

CONTACT

+923333727189; Phyranamuhammadtahir@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: March 2, 2023
• Study Start: March 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)