Clinical trial NCT05751499: Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain
Official title: Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
Collaborators: name: KRL Hospital, Islamabad
First posted: 2023-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PEOPLE BETWEEN 18 TO 60 YEARS HAVING LOW BACK PAIN WITH NON SPECIFIC REASON

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

Detailed description: * To compare the diagnostic and prognostic blood markers in acute and chronic nonspecific low back pain with healthy controls
* To predict the diagnostic and prognostic blood markers on sleep, depression and anxiety in acute and chronic non specific low back pain.
* To compare the effect of physical activity with blood markers in acute and chronic non specific low back pain.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: CRP
timeFrame: 0 weeks [at the start of data]
measure: CRP
timeFrame: 8th weeks
measure: CRP
timeFrame: 16th weeks
measure: CRP
timeFrame: 24th weeks
measure: TNF ALPHA
timeFrame: 0 weeks
measure: TNF ALPHA
timeFrame: 8 weeks
measure: TNF ALPHA
timeFrame: 16 weeks
measure: TNF ALPHA
timeFrame: 24 weeks
measure: IL 1
timeFrame: 0 weeks
measure: IL 1
timeFrame: 8 weeks
measure: IL 1
timeFrame: 16 weeks
measure: IL 1
timeFrame: 24 weeks
measure: IL 6
timeFrame: 0 weeks
measure: IL 6
timeFrame: 8 weeks
measure: IL 6
timeFrame: 16 weeks
measure: IL 6
timeFrame: 24 weeks
measure: IL-8
timeFrame: 0 weeks
measure: IL-8
timeFrame: 8 weeks
measure: IL-8
timeFrame: 16 weeks
measure: IL-8
timeFrame: 24 weeks
measure: IL-1 BETA
timeFrame: 0 weeks
measure: IL-1 BETA
timeFrame: 8 weeks
measure: IL-1 BETA
timeFrame: 16 weeks
measure: IL-1 BETA
timeFrame: 24 weeks
measure: Fibrinogen
timeFrame: 0 weeks
measure: Fibrinogen
timeFrame: 8 weeks
measure: Fibrinogen
timeFrame: 16 weeks
measure: Fibrinogen
timeFrame: 24 weeks
Secondary outcomes:
measure: Numeric rating scale
timeFrame: 0 weeks
measure: Numeric rating scale
timeFrame: 8 weeks
measure: Numeric rating scale
timeFrame: 16 weeks
measure: Numeric rating scale
timeFrame: 24 weeks
measure: Low Back outcome scale
timeFrame: 0 weeks
measure: Low Back outcome scale
timeFrame: 8 weeks
measure: Low Back outcome scale
timeFrame: 16 weeks
measure: Low Back outcome scale
timeFrame: 24 weeks
measure: Center for Epidemiological Studies-Depression Scale (CES-D):
timeFrame: 0 weeks
measure: Center for Epidemiological Studies-Depression Scale (CES-D):
timeFrame: 8 weeks
measure: Center for Epidemiological Studies-Depression Scale (CES-D):
timeFrame: 16 weeks
measure: Center for Epidemiological Studies-Depression Scale (CES-D):
timeFrame: 24 weeks
measure: Pain catastrophizing scale
timeFrame: 0 weeks
measure: Pain catastrophizing scale
timeFrame: 8 weeks
measure: Pain catastrophizing scale
timeFrame: 16 weeks
measure: Pain catastrophizing scale
timeFrame: 24 weeks
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: 0 weeks
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: 8 weeks
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: 16 weeks
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: 24 weeks
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: 0 weeks
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: 8 weeks
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: 16 weeks
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: 24 weeks
measure: Job Content Questionnaire
timeFrame: 0 weeks
measure: Job Content Questionnaire
timeFrame: 8 weeks
measure: Job Content Questionnaire
timeFrame: 16 weeks
measure: Job Content Questionnaire
timeFrame: 24 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 0 week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 16 week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 24 week
measure: International Physical Activity Questionnaire
timeFrame: 0 weeks
measure: International Physical Activity Questionnaire
timeFrame: 8 weeks
measure: International Physical Activity Questionnaire
timeFrame: 16 weeks
measure: International Physical Activity Questionnaire
timeFrame: 24 weeks
measure: Roland-Morris Disability Questionnaire
timeFrame: 0 weeks
measure: Roland-Morris Disability Questionnaire
timeFrame: 8 weeks
measure: Roland-Morris Disability Questionnaire
timeFrame: 16 weeks
measure: Roland-Morris Disability Questionnaire
timeFrame: 24 weeks
measure: Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ)
timeFrame: 0 weeks
measure: Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ)
timeFrame: 8 weeks
measure: Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ)
timeFrame: 16 weeks
measure: Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ)
timeFrame: 24 weeks
measure: Keele STarT Back Screening Tool (SBST)
timeFrame: 0 weeks
measure: Keele STarT Back Screening Tool (SBST)
timeFrame: 8 weeks
measure: Keele STarT Back Screening Tool (SBST)
timeFrame: 16 weeks
measure: Keele STarT Back Screening Tool (SBST)
timeFrame: 24 weeks
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 0 weeks
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 8 weeks
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 16 weeks
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 24 weeks
measure: Coping Strategies Questionnaire
timeFrame: 0 weeks
measure: Coping Strategies Questionnaire
timeFrame: 8 weeks
measure: Coping Strategies Questionnaire
timeFrame: 16 weeks
measure: Coping Strategies Questionnaire
timeFrame: 24 weeks
measure: Chronic Pain Grade Scale
timeFrame: 0 weeks
measure: Chronic Pain Grade Scale
timeFrame: 8 weeks
measure: Chronic Pain Grade Scale
timeFrame: 16 weeks
measure: Chronic Pain Grade Scale
timeFrame: 24 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 0 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 8 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 16 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 24 weeks
Other outcomes:
measure: Gait & Balance App:
timeFrame: 0 weeks
measure: Gait & Balance App:
timeFrame: 8 weeks
measure: Gait & Balance App:
timeFrame: 16 weeks
measure: Gait & Balance App:
timeFrame: 24 weeks
measure: Force Platform
timeFrame: 0 weeks
measure: Force Platform
timeFrame: 8 weeks
measure: Force Platform
timeFrame: 16 weeks
measure: Force Platform
timeFrame: 24 weeks
Locations:
city: Islamabad
country: Pakistan
facility: KRL Hospital
Study officials:
affiliation: Faculty of Rehabilitation & Allied Health Sciences, Riphah International University
name: Waqar A Awan, PhD
role: STUDY_DIRECTOR
affiliation: Riphah International University
name: IMRAN AMJAD, PhD
role: PRINCIPAL_INVESTIGATOR
References: