Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Diagnostic Test: • Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN
- Registration Number
- NCT05751499
- Lead Sponsor
- Riphah International University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Both male & Female patients
- Age group 18-60 Years
- Diagnosed with nonspecific low back pain in acute/flared stage
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CASE GROUP • Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN 1. Both male \& Female patients 2. Age group 18-60 Years 3. Diagnosed with nonspecific low back pain in acute/flared stage CONTROL GROUP • Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN MALE AND FEMALE AGE GROUP 18 TO 60 YEARS NOT SUFFERING FROM LOW BACK PAIN
- Primary Outcome Measures
Name Time Method IL 6 24 weeks Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
IL 1 24 weeks Interleukin-1 is a group of 11 cytokines that plays a central role in the regulation of immune and inflammatory response to infections
CRP 24th weeks 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
IL-1 BETA 24 weeks IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
Fibrinogen 24 weeks Fibrinogen is a protein produced by liver, its high levels may occur as a part of normal response to infection or inflammation.
TNF ALPHA 24 weeks TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
IL-8 24 weeks Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions
- Secondary Outcome Measures
Name Time Method Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) 24 weeks The ÖMPQ is a screening questionnaire used to predict long term disability and failure to return to work due to personal and environmental factors. The ÖMPQ score is used as a predictor of risk of long-term disability and failed return to work, with a higher score indicating higher risk.
Numeric rating scale 24 weeks Self-reported pain intensity will be measured using an 11-point NRS ranging from "none" to "worst imaginable pain
Low Back outcome scale 24 weeks The Low Back outcome scale evaluates pain and physical function. It has a score in the range from 0 to 75 and the higher score indicates better condition. It categorizes patients into a 4-grade classification scheme: excellent ≥65; good 50-64; fair 30-49, and poor 0-29.
International Physical Activity Questionnaire 24 weeks IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.
Chronic Pain Grade Scale 24 weeks The CPGS is a multidimensional measure that assesses 2 dimensions of overall chronic pain severity: pain intensity and pain-related disability. It has 7 items. Subscale scores for pain intensity and disability are combined to calculate a chronic pain grade that enables classification of chronic pain patients into 5 hierarchical categories: grades 0 (no pain) to IV (high disability-severely limiting): grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting
Hospital Anxiety and Depression Scale 24 weeks It is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients and measure symptoms of anxiety and depression. The questionnaire comprises seven questions for anxiety and seven questions for depression, and score ranges from 8 (mild) to 21 (severe symptoms).
Pain Self-Efficacy Questionnaire (PSEQ) 24 weeks The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain.
Roland-Morris Disability Questionnaire 24 weeks Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain.(18) The score ranges from 0 (no disability) to 11, 18 or 24 (max. disability) depending on the questionnaire that is used.
Coping Strategies Questionnaire 24 weeks The Coping Strategies Questionnaire (CSQ) is a 27-item tool which was developed in 1983 and it reflect the coping strategies frequently reported by patients in the management of pain.
Center for Epidemiological Studies-Depression Scale (CES-D): 24 weeks Centre for epidemiological studies of depression scale (CES-D) evaluates depressive symptoms. It has score range of 0 to 60 with higher score indicating increased depressive symptoms.
Pain catastrophizing scale 24 weeks Pain catastrophizing scale is used for measuring catastrophic thinking related to pain. The total score ranges from 0-52, along with three subscale scores assessing rumination, magnification and helplessness
Job Content Questionnaire 24 weeks It is a questionnaire-based instrument designed to measure the "content" of a respondent's work tasks in a general manner which is applicable to all jobs and jobholders. It consists of 27 items quantified on a four-point Likert scale ranging from 1 (totally disagree) to 4 (totally agree).
Pittsburgh Sleep Quality Index (PSQI) 24 week The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. It has a score range of 0-21 where higher score indicates poor sleep.
Tampa Scale of Kinesiophobia (TSK) 24 weeks It is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale ranges from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.
Fear-Avoidance Beliefs Questionnaire (FABQ) 24 weeks The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient reported questionnaire which measures patients' fear of pain and consequent avoidance of physical activity because of their fear. It is a 7-point Likert scale where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
Keele STarT Back Screening Tool (SBST) 24 weeks The Keele STarT Back Screening Tool (SBST) (9-item version) is a brief validated tool, designed to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making. It helps primary care clinicians to group patients into three categories of risk of poor outcome - low, medium, and high-risk.
Trial Locations
- Locations (1)
KRL Hospital
🇵🇰Islamabad, Pakistan