Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain

Low Back Pain Clinical Trial

Official title:

Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05751499
• Other study ID #: Rana Muhammad Tahir
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: July 2023
• Source: Riphah International University
• Contact: Rana M Tahir, PhD*
• Phone: +923333727189
• Email: Phyranamuhammadtahir[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Diagnostic Test:
• • Blood Markers CRP, TNFa, IL-6, IL-8, IL-1, and IL-1ß 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

Locations

Country	Name	City	State
Pakistan	KRL Hospital	Islamabad

Sponsors (2)

Lead Sponsor	Collaborator
Riphah International University	KRL Hospital, Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gait & Balance App:	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	0 weeks
Other	Gait & Balance App:	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	8 weeks
Other	Gait & Balance App:	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	16 weeks
Other	Gait & Balance App:	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	24 weeks
Other	Force Platform	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	0 weeks
Other	Force Platform	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	8 weeks
Other	Force Platform	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	16 weeks
Other	Force Platform	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	24 weeks
Primary	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]
Primary	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
Primary	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
Primary	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
Primary	TNF ALPHA	TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.	0 weeks
Primary	TNF ALPHA	TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.	8 weeks
Primary	TNF ALPHA	TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.	16 weeks
Primary	TNF ALPHA	TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.	24 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	IL 6	Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.	0 weeks
Primary	IL 6	Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.	8 weeks
Primary	IL 6	Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.	16 weeks
Primary	IL 6	Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.	24 weeks
Primary	IL-8	Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions	0 weeks
Primary	IL-8	Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions	8 weeks
Primary	IL-8	Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions	16 weeks
Primary	IL-8	Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions	24 weeks
Primary	IL-1 BETA	IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition	0 weeks
Primary	IL-1 BETA	IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition	8 weeks
Primary	IL-1 BETA	IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition	16 weeks
Primary	IL-1 BETA	IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition	24 weeks
Primary	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
Primary	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
Primary	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
Primary	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	Numeric rating scale	Self-reported pain intensity will be measured using an 11-point NRS ranging from "none" to "worst imaginable pain	0 weeks
Secondary	Numeric rating scale	Self-reported pain intensity will be measured using an 11-point NRS ranging from "none" to "worst imaginable pain	8 weeks
Secondary	Numeric rating scale	Self-reported pain intensity will be measured using an 11-point NRS ranging from "none" to "worst imaginable pain	16 weeks
Secondary	Numeric rating scale	Self-reported pain intensity will be measured using an 11-point NRS ranging from "none" to "worst imaginable pain	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	International Physical Activity Questionnaire	IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.	0 weeks
Secondary	International Physical Activity Questionnaire	IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.	8 weeks
Secondary	International Physical Activity Questionnaire	IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.	16 weeks
Secondary	International Physical Activity Questionnaire	IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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