Low Back Pain
Conditions
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.
Interventions
DIAGNOSTIC_TEST• Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN
* 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
Sponsors
KRL Hospital, Islamabad
Riphah International University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IL-1 BETA | 0 weeks | IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition |
| Fibrinogen | 0 weeks | Fibrinogen is a protein produced by liver, its high levels may occur as a part of normal response to infection or inflammation. |
| CRP | 0 weeks [at the start of data] | 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 |
| TNF ALPHA | 0 weeks | TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine. |
| IL 1 | 0 weeks | Interleukin-1 is a group of 11 cytokines that plays a central role in the regulation of immune and inflammatory response to infections |
| IL 6 | 0 weeks | Interleukin-6 promptly and transiently produced in response to infections and tissues injuries. |
| IL-8 | 0 weeks | Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Job Content Questionnaire | 0 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) | 0 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. |
| International Physical Activity Questionnaire | 0 weeks | IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity. |
| Roland-Morris Disability Questionnaire | 0 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. |
| Keele STarT Back Screening Tool (SBST) | 0 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. |
| Tampa Scale of Kinesiophobia (TSK) | 0 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. |
| Coping Strategies Questionnaire | 0 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. |
| Chronic Pain Grade Scale | 0 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 | 0 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). |
| Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) | 0 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 | 0 weeks | Self-reported pain intensity will be measured using an 11-point NRS ranging from none to worst imaginable pain |
| Low Back outcome scale | 0 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. |
| Center for Epidemiological Studies-Depression Scale (CES-D): | 0 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 | 0 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 |
| Fear-Avoidance Beliefs Questionnaire (FABQ) | 0 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. |
| Pain Self-Efficacy Questionnaire (PSEQ) | 0 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gait & Balance App: | 0 weeks | Using the Iphone 6 plus, this app will be installed in the phone and it will be used to measure balance and gait parameters. The phone will be fixed to patient's back with a securing balance during the performance of tasks |
| Force Platform | 0 weeks | Force platform (Pasco PASPORT force platform-PS2141) will be used to analyze the patient's data for standing postural control. This platform has shown good reliability and validity. It will be measured with participants standing barefoot and blindfolded on a force plate for 75s. To test the effect of disruption of proprioception at the calf and lower back, the task will be repeated with vibrators (\ 60 Hz, 1 mm amplitude) attached bilaterally over the Achilles tendon and lumbar paraspinal muscles, separately, in random order. Vibrators will be switched on for 15 s at \ 15 s after the start of the trial. Coordinates of CoP will be recorded |
Countries
Pakistan
Contacts
Primary ContactRana M Tahir, PhD*
Outcome results
None listed