Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain

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

Detailed Description
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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.

Official Title
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Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain

Conditions
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Low Back Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both male & Female patients Age group 18-60 Years 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CASE GROUP<br>Both male & Female patients Age group 18-60 Years 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<br>* 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<br>|
| CONTROL GROUP<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale | Self-reported pain intensity will be measured using an 11-point NRS ranging from none to worst imaginable pain | 0 weeks | 
| Numeric rating scale | Self-reported pain intensity will be measured using an 11-point NRS ranging from none to worst imaginable pain | 8 weeks | 
| Numeric rating scale | Self-reported pain intensity will be measured using an 11-point NRS ranging from none to worst imaginable pain | 16 weeks | 
| Numeric rating scale | Self-reported pain intensity will be measured using an 11-point NRS ranging from none to worst imaginable pain | 24 weeks | 
| Low Back outcome scale | 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. | 0 weeks | 
| Low Back outcome scale | 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. | 8 weeks | 
| Low Back outcome scale | 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. | 16 weeks | 
| Low Back outcome scale | 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. | 24 weeks | 
| Center for Epidemiological Studies-Depression Scale (CES-D): | 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. | 0 weeks | 
| Center for Epidemiological Studies-Depression Scale (CES-D): | 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. | 8 weeks | 
| Center for Epidemiological Studies-Depression Scale (CES-D): | 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. | 16 weeks | 
| Center for Epidemiological Studies-Depression Scale (CES-D): | 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. | 24 weeks | 
| Pain catastrophizing scale | 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 | 0 weeks | 
| Pain catastrophizing scale | 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 | 8 weeks | 
| Pain catastrophizing scale | 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 | 16 weeks | 
| Pain catastrophizing scale | 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 | 24 weeks | 
| Fear-Avoidance Beliefs Questionnaire (FABQ) | 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. | 0 weeks | 
| Fear-Avoidance Beliefs Questionnaire (FABQ) | 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. | 8 weeks | 
| Fear-Avoidance Beliefs Questionnaire (FABQ) | 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. | 16 weeks | 
| Fear-Avoidance Beliefs Questionnaire (FABQ) | 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. | 24 weeks | 
| Pain Self-Efficacy Questionnaire (PSEQ) | 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. | 0 weeks | 
| Pain Self-Efficacy Questionnaire (PSEQ) | 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. | 8 weeks | 
| Pain Self-Efficacy Questionnaire (PSEQ) | 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. | 16 weeks | 
| Pain Self-Efficacy Questionnaire (PSEQ) | 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. | 24 weeks | 
| Job Content Questionnaire | 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). | 0 weeks | 
| Job Content Questionnaire | 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). | 8 weeks | 
| Job Content Questionnaire | 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). | 16 weeks | 
| Job Content Questionnaire | 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). | 24 weeks | 
| Pittsburgh Sleep Quality Index (PSQI) | 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. | 0 week | 
| Pittsburgh Sleep Quality Index (PSQI) | 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. | 8 week | 
| Pittsburgh Sleep Quality Index (PSQI) | 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. | 16 week | 
| Pittsburgh Sleep Quality Index (PSQI) | 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. | 24 week | 
| International Physical Activity Questionnaire | IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity. | 0 weeks | 
| International Physical Activity Questionnaire | IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity. | 8 weeks | 
| International Physical Activity Questionnaire | IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity. | 16 weeks | 
| International Physical Activity Questionnaire | IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity. | 24 weeks | 
| Roland-Morris Disability Questionnaire | 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. | 0 weeks | 
| Roland-Morris Disability Questionnaire | 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. | 8 weeks | 
| Roland-Morris Disability Questionnaire | 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. | 16 weeks | 
| Roland-Morris Disability Questionnaire | 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. | 24 weeks | 
| Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) | 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. | 0 weeks | 
| Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) | 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. | 8 weeks | 
| Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) | 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. | 16 weeks | 
| Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) | 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. | 24 weeks | 
| Keele STarT Back Screening Tool (SBST) | 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. | 0 weeks | 
| Keele STarT Back Screening Tool (SBST) | 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. | 8 weeks | 
| Keele STarT Back Screening Tool (SBST) | 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. | 16 weeks | 
| Keele STarT Back Screening Tool (SBST) | 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. | 24 weeks | 
| Tampa Scale of Kinesiophobia (TSK) | 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. | 0 weeks | 
| Tampa Scale of Kinesiophobia (TSK) | 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. | 8 weeks | 
| Tampa Scale of Kinesiophobia (TSK) | 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. | 16 weeks | 
| Tampa Scale of Kinesiophobia (TSK) | 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. | 24 weeks | 
| Coping Strategies Questionnaire | 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. | 0 weeks | 
| Coping Strategies Questionnaire | 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. | 8 weeks | 
| Coping Strategies Questionnaire | 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. | 16 weeks | 
| Coping Strategies Questionnaire | 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. | 24 weeks | 
| Chronic Pain Grade Scale | 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 | 0 weeks | 
| Chronic Pain Grade Scale | 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 | 8 weeks | 
| Chronic Pain Grade Scale | 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 | 16 weeks | 
| Chronic Pain Grade Scale | 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 | 24 weeks | 
| Hospital Anxiety and Depression Scale | 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). | 0 weeks | 
| Hospital Anxiety and Depression Scale | 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). | 8 weeks | 
| Hospital Anxiety and Depression Scale | 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). | 16 weeks | 
| Hospital Anxiety and Depression Scale | 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). | 24 weeks |