Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain

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

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Diagnostic test: • Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Rana M Tahir, PhD*; Phone Number: +923333727189; Email: Phyranamuhammadtahir@gmail.com

Study Locations

• Pakistan
  • Islamabad, Pakistan, 44000
    • Recruiting
    • KRL Hospital
    • Contact: Rana M Tahir, PhD*; Phone Number: 03333727189; Email: phyranamuhammadtahir@gmail.com
    • Principal Investigator: Rana Muhammad Tahir, PhD*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

PEOPLE BETWEEN 18 TO 60 YEARS HAVING LOW BACK PAIN WITH NON SPECIFIC REASON

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CASE GROUP; 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; 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
CONTROL GROUP; 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; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Collaborators: KRL Hospital, Islamabad
• Investigators: Study Director: Waqar A Awan, PhD, Faculty of Rehabilitation & Allied Health Sciences, Riphah International University; Principal Investigator: Imran Amjad, Phd, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: December 17, 2022
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Rana Muhammad Tahir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes