Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain

July 25, 2023 updated by: Riphah International University
• To compare the diagnostic and prognostic blood markers in acute and chronic nonspecific low back pain with healthy controls

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Recruiting
        • KRL Hospital
        • Contact:
        • Principal Investigator:
          • Rana Muhammad Tahir, PhD*

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CASE GROUP
  1. Both male & Female patients
  2. Age group 18-60 Years
  3. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CRP
Time Frame: 0 weeks [at the start of data]
It measures the level of C-reactive proteins in a sample of blood. CRP is a protein made by lever. It shows inflammation in the body
0 weeks [at the start of data]
CRP
Time Frame: 8th weeks
It measures the level of C-reactive proteins in a sample of blood. CRP is a protein made by lever. It shows inflammation in the body
8th weeks
CRP
Time Frame: 16th weeks
It measures the level of C-reactive proteins in a sample of blood. CRP is a protein made by lever. It shows inflammation in the body
16th weeks
CRP
Time Frame: 24th weeks
It measures the level of C-reactive proteins in a sample of blood. CRP is a protein made by lever. It shows inflammation in the body
24th weeks
TNF ALPHA
Time Frame: 0 weeks
TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
0 weeks
TNF ALPHA
Time Frame: 8 weeks
TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
8 weeks
TNF ALPHA
Time Frame: 16 weeks
TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
16 weeks
TNF ALPHA
Time Frame: 24 weeks
TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
24 weeks
IL 1
Time Frame: 0 weeks
Interleukin-1 is a group of 11 cytokines that plays a central role in the regulation of immune and inflammatory response to infections
0 weeks
IL 1
Time Frame: 8 weeks
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
Time Frame: 16 weeks
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
Time Frame: 24 weeks
Interleukin-1 is a group of 11 cytokines that plays a central role in the regulation of immune and inflammatory response to infections
24 weeks
IL 6
Time Frame: 0 weeks
Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
0 weeks
IL 6
Time Frame: 8 weeks
Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
8 weeks
IL 6
Time Frame: 16 weeks
Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
16 weeks
IL 6
Time Frame: 24 weeks
Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
24 weeks
IL-8
Time Frame: 0 weeks
Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions
0 weeks
IL-8
Time Frame: 8 weeks
Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions
8 weeks
IL-8
Time Frame: 16 weeks
Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions
16 weeks
IL-8
Time Frame: 24 weeks
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
Time Frame: 0 weeks
IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
0 weeks
IL-1 BETA
Time Frame: 8 weeks
IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
8 weeks
IL-1 BETA
Time Frame: 16 weeks
IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
16 weeks
IL-1 BETA
Time Frame: 24 weeks
IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
24 weeks
Fibrinogen
Time Frame: 0 weeks
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
Time Frame: 8 weeks
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
Time Frame: 16 weeks
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
Time Frame: 24 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numeric rating scale
Time Frame: 0 weeks
Self-reported pain intensity will be measured using an 11-point NRS ranging from "none" to "worst imaginable pain
0 weeks
Numeric rating scale
Time Frame: 8 weeks
Self-reported pain intensity will be measured using an 11-point NRS ranging from "none" to "worst imaginable pain
8 weeks
Numeric rating scale
Time Frame: 16 weeks
Self-reported pain intensity will be measured using an 11-point NRS ranging from "none" to "worst imaginable pain
16 weeks
Numeric rating scale
Time Frame: 24 weeks
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
Time Frame: 0 weeks
The Low Back outcome scale evaluates pain and physical function. It has a score in the range from 0 to 75 and the higher score indicates better condition. It categorizes patients into a 4-grade classification scheme: excellent ≥65; good 50-64; fair 30-49, and poor 0-29.
0 weeks
Low Back outcome scale
Time Frame: 8 weeks
The Low Back outcome scale evaluates pain and physical function. It has a score in the range from 0 to 75 and the higher score indicates better condition. It categorizes patients into a 4-grade classification scheme: excellent ≥65; good 50-64; fair 30-49, and poor 0-29.
8 weeks
Low Back outcome scale
Time Frame: 16 weeks
The Low Back outcome scale evaluates pain and physical function. It has a score in the range from 0 to 75 and the higher score indicates better condition. It categorizes patients into a 4-grade classification scheme: excellent ≥65; good 50-64; fair 30-49, and poor 0-29.
16 weeks
Low Back outcome scale
Time Frame: 24 weeks
The Low Back outcome scale evaluates pain and physical function. It has a score in the range from 0 to 75 and the higher score indicates better condition. It categorizes patients into a 4-grade classification scheme: excellent ≥65; good 50-64; fair 30-49, and poor 0-29.
24 weeks
Center for Epidemiological Studies-Depression Scale (CES-D):
Time Frame: 0 weeks
Centre for epidemiological studies of depression scale (CES-D) evaluates depressive symptoms. It has score range of 0 to 60 with higher score indicating increased depressive symptoms.
0 weeks
Center for Epidemiological Studies-Depression Scale (CES-D):
Time Frame: 8 weeks
Centre for epidemiological studies of depression scale (CES-D) evaluates depressive symptoms. It has score range of 0 to 60 with higher score indicating increased depressive symptoms.
8 weeks
Center for Epidemiological Studies-Depression Scale (CES-D):
Time Frame: 16 weeks
Centre for epidemiological studies of depression scale (CES-D) evaluates depressive symptoms. It has score range of 0 to 60 with higher score indicating increased depressive symptoms.
16 weeks
Center for Epidemiological Studies-Depression Scale (CES-D):
Time Frame: 24 weeks
Centre for epidemiological studies of depression scale (CES-D) evaluates depressive symptoms. It has score range of 0 to 60 with higher score indicating increased depressive symptoms.
24 weeks
Pain catastrophizing scale
Time Frame: 0 weeks
Pain catastrophizing scale is used for measuring catastrophic thinking related to pain. The total score ranges from 0-52, along with three subscale scores assessing rumination, magnification and helplessness
0 weeks
Pain catastrophizing scale
Time Frame: 8 weeks
Pain catastrophizing scale is used for measuring catastrophic thinking related to pain. The total score ranges from 0-52, along with three subscale scores assessing rumination, magnification and helplessness
8 weeks
Pain catastrophizing scale
Time Frame: 16 weeks
Pain catastrophizing scale is used for measuring catastrophic thinking related to pain. The total score ranges from 0-52, along with three subscale scores assessing rumination, magnification and helplessness
16 weeks
Pain catastrophizing scale
Time Frame: 24 weeks
Pain catastrophizing scale is used for measuring catastrophic thinking related to pain. The total score ranges from 0-52, along with three subscale scores assessing rumination, magnification and helplessness
24 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time Frame: 0 weeks
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient reported questionnaire which measures patients' fear of pain and consequent avoidance of physical activity because of their fear. It is a 7-point Likert scale where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
0 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time Frame: 8 weeks
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient reported questionnaire which measures patients' fear of pain and consequent avoidance of physical activity because of their fear. It is a 7-point Likert scale where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
8 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time Frame: 16 weeks
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient reported questionnaire which measures patients' fear of pain and consequent avoidance of physical activity because of their fear. It is a 7-point Likert scale where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
16 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time Frame: 24 weeks
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient reported questionnaire which measures patients' fear of pain and consequent avoidance of physical activity because of their fear. It is a 7-point Likert scale where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
24 weeks
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: 0 weeks
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain.
0 weeks
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: 8 weeks
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain.
8 weeks
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: 16 weeks
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain.
16 weeks
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: 24 weeks
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain.
24 weeks
Job Content Questionnaire
Time Frame: 0 weeks
It is a questionnaire-based instrument designed to measure the "content" of a respondent's work tasks in a general manner which is applicable to all jobs and jobholders. It consists of 27 items quantified on a four-point Likert scale ranging from 1 (totally disagree) to 4 (totally agree).
0 weeks
Job Content Questionnaire
Time Frame: 8 weeks
It is a questionnaire-based instrument designed to measure the "content" of a respondent's work tasks in a general manner which is applicable to all jobs and jobholders. It consists of 27 items quantified on a four-point Likert scale ranging from 1 (totally disagree) to 4 (totally agree).
8 weeks
Job Content Questionnaire
Time Frame: 16 weeks
It is a questionnaire-based instrument designed to measure the "content" of a respondent's work tasks in a general manner which is applicable to all jobs and jobholders. It consists of 27 items quantified on a four-point Likert scale ranging from 1 (totally disagree) to 4 (totally agree).
16 weeks
Job Content Questionnaire
Time Frame: 24 weeks
It is a questionnaire-based instrument designed to measure the "content" of a respondent's work tasks in a general manner which is applicable to all jobs and jobholders. It consists of 27 items quantified on a four-point Likert scale ranging from 1 (totally disagree) to 4 (totally agree).
24 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 0 week
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. It has a score range of 0-21 where higher score indicates poor sleep.
0 week
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 8 week
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. It has a score range of 0-21 where higher score indicates poor sleep.
8 week
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 16 week
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. It has a score range of 0-21 where higher score indicates poor sleep.
16 week
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 24 week
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. It has a score range of 0-21 where higher score indicates poor sleep.
24 week
International Physical Activity Questionnaire
Time Frame: 0 weeks
IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.
0 weeks
International Physical Activity Questionnaire
Time Frame: 8 weeks
IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.
8 weeks
International Physical Activity Questionnaire
Time Frame: 16 weeks
IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.
16 weeks
International Physical Activity Questionnaire
Time Frame: 24 weeks
IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.
24 weeks
Roland-Morris Disability Questionnaire
Time Frame: 0 weeks
Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain.(18) The score ranges from 0 (no disability) to 11, 18 or 24 (max. disability) depending on the questionnaire that is used.
0 weeks
Roland-Morris Disability Questionnaire
Time Frame: 8 weeks
Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain.(18) The score ranges from 0 (no disability) to 11, 18 or 24 (max. disability) depending on the questionnaire that is used.
8 weeks
Roland-Morris Disability Questionnaire
Time Frame: 16 weeks
Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain.(18) The score ranges from 0 (no disability) to 11, 18 or 24 (max. disability) depending on the questionnaire that is used.
16 weeks
Roland-Morris Disability Questionnaire
Time Frame: 24 weeks
Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain.(18) The score ranges from 0 (no disability) to 11, 18 or 24 (max. disability) depending on the questionnaire that is used.
24 weeks
Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ)
Time Frame: 0 weeks
The ÖMPQ is a screening questionnaire used to predict long term disability and failure to return to work due to personal and environmental factors. The ÖMPQ score is used as a predictor of risk of long-term disability and failed return to work, with a higher score indicating higher risk.
0 weeks
Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ)
Time Frame: 8 weeks
The ÖMPQ is a screening questionnaire used to predict long term disability and failure to return to work due to personal and environmental factors. The ÖMPQ score is used as a predictor of risk of long-term disability and failed return to work, with a higher score indicating higher risk.
8 weeks
Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ)
Time Frame: 16 weeks
The ÖMPQ is a screening questionnaire used to predict long term disability and failure to return to work due to personal and environmental factors. The ÖMPQ score is used as a predictor of risk of long-term disability and failed return to work, with a higher score indicating higher risk.
16 weeks
Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ)
Time Frame: 24 weeks
The ÖMPQ is a screening questionnaire used to predict long term disability and failure to return to work due to personal and environmental factors. The ÖMPQ score is used as a predictor of risk of long-term disability and failed return to work, with a higher score indicating higher risk.
24 weeks
Keele STarT Back Screening Tool (SBST)
Time Frame: 0 weeks
The Keele STarT Back Screening Tool (SBST) (9-item version) is a brief validated tool, designed to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making. It helps primary care clinicians to group patients into three categories of risk of poor outcome - low, medium, and high-risk.
0 weeks
Keele STarT Back Screening Tool (SBST)
Time Frame: 8 weeks
The Keele STarT Back Screening Tool (SBST) (9-item version) is a brief validated tool, designed to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making. It helps primary care clinicians to group patients into three categories of risk of poor outcome - low, medium, and high-risk.
8 weeks
Keele STarT Back Screening Tool (SBST)
Time Frame: 16 weeks
The Keele STarT Back Screening Tool (SBST) (9-item version) is a brief validated tool, designed to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making. It helps primary care clinicians to group patients into three categories of risk of poor outcome - low, medium, and high-risk.
16 weeks
Keele STarT Back Screening Tool (SBST)
Time Frame: 24 weeks
The Keele STarT Back Screening Tool (SBST) (9-item version) is a brief validated tool, designed to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making. It helps primary care clinicians to group patients into three categories of risk of poor outcome - low, medium, and high-risk.
24 weeks
Tampa Scale of Kinesiophobia (TSK)
Time Frame: 0 weeks
It is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale ranges from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.
0 weeks
Tampa Scale of Kinesiophobia (TSK)
Time Frame: 8 weeks
It is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale ranges from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.
8 weeks
Tampa Scale of Kinesiophobia (TSK)
Time Frame: 16 weeks
It is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale ranges from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.
16 weeks
Tampa Scale of Kinesiophobia (TSK)
Time Frame: 24 weeks
It is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale ranges from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.
24 weeks
Coping Strategies Questionnaire
Time Frame: 0 weeks
The Coping Strategies Questionnaire (CSQ) is a 27-item tool which was developed in 1983 and it reflect the coping strategies frequently reported by patients in the management of pain.
0 weeks
Coping Strategies Questionnaire
Time Frame: 8 weeks
The Coping Strategies Questionnaire (CSQ) is a 27-item tool which was developed in 1983 and it reflect the coping strategies frequently reported by patients in the management of pain.
8 weeks
Coping Strategies Questionnaire
Time Frame: 16 weeks
The Coping Strategies Questionnaire (CSQ) is a 27-item tool which was developed in 1983 and it reflect the coping strategies frequently reported by patients in the management of pain.
16 weeks
Coping Strategies Questionnaire
Time Frame: 24 weeks
The Coping Strategies Questionnaire (CSQ) is a 27-item tool which was developed in 1983 and it reflect the coping strategies frequently reported by patients in the management of pain.
24 weeks
Chronic Pain Grade Scale
Time Frame: 0 weeks
The CPGS is a multidimensional measure that assesses 2 dimensions of overall chronic pain severity: pain intensity and pain-related disability. It has 7 items. Subscale scores for pain intensity and disability are combined to calculate a chronic pain grade that enables classification of chronic pain patients into 5 hierarchical categories: grades 0 (no pain) to IV (high disability-severely limiting): grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting
0 weeks
Chronic Pain Grade Scale
Time Frame: 8 weeks
The CPGS is a multidimensional measure that assesses 2 dimensions of overall chronic pain severity: pain intensity and pain-related disability. It has 7 items. Subscale scores for pain intensity and disability are combined to calculate a chronic pain grade that enables classification of chronic pain patients into 5 hierarchical categories: grades 0 (no pain) to IV (high disability-severely limiting): grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting
8 weeks
Chronic Pain Grade Scale
Time Frame: 16 weeks
The CPGS is a multidimensional measure that assesses 2 dimensions of overall chronic pain severity: pain intensity and pain-related disability. It has 7 items. Subscale scores for pain intensity and disability are combined to calculate a chronic pain grade that enables classification of chronic pain patients into 5 hierarchical categories: grades 0 (no pain) to IV (high disability-severely limiting): grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting
16 weeks
Chronic Pain Grade Scale
Time Frame: 24 weeks
The CPGS is a multidimensional measure that assesses 2 dimensions of overall chronic pain severity: pain intensity and pain-related disability. It has 7 items. Subscale scores for pain intensity and disability are combined to calculate a chronic pain grade that enables classification of chronic pain patients into 5 hierarchical categories: grades 0 (no pain) to IV (high disability-severely limiting): grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting
24 weeks
Hospital Anxiety and Depression Scale
Time Frame: 0 weeks
It is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients and measure symptoms of anxiety and depression. The questionnaire comprises seven questions for anxiety and seven questions for depression, and score ranges from 8 (mild) to 21 (severe symptoms).
0 weeks
Hospital Anxiety and Depression Scale
Time Frame: 8 weeks
It is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients and measure symptoms of anxiety and depression. The questionnaire comprises seven questions for anxiety and seven questions for depression, and score ranges from 8 (mild) to 21 (severe symptoms).
8 weeks
Hospital Anxiety and Depression Scale
Time Frame: 16 weeks
It is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients and measure symptoms of anxiety and depression. The questionnaire comprises seven questions for anxiety and seven questions for depression, and score ranges from 8 (mild) to 21 (severe symptoms).
16 weeks
Hospital Anxiety and Depression Scale
Time Frame: 24 weeks
It is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients and measure symptoms of anxiety and depression. The questionnaire comprises seven questions for anxiety and seven questions for depression, and score ranges from 8 (mild) to 21 (severe symptoms).
24 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gait & Balance App:
Time Frame: 0 weeks
Using the Iphone 6 plus, this app will be installed in the phone and it will be used to measure balance and gait parameters. The phone will be fixed to patient's back with a securing balance during the performance of tasks
0 weeks
Gait & Balance App:
Time Frame: 8 weeks
Using the Iphone 6 plus, this app will be installed in the phone and it will be used to measure balance and gait parameters. The phone will be fixed to patient's back with a securing balance during the performance of tasks
8 weeks
Gait & Balance App:
Time Frame: 16 weeks
Using the Iphone 6 plus, this app will be installed in the phone and it will be used to measure balance and gait parameters. The phone will be fixed to patient's back with a securing balance during the performance of tasks
16 weeks
Gait & Balance App:
Time Frame: 24 weeks
Using the Iphone 6 plus, this app will be installed in the phone and it will be used to measure balance and gait parameters. The phone will be fixed to patient's back with a securing balance during the performance of tasks
24 weeks
Force Platform
Time Frame: 0 weeks
Force platform (Pasco PASPORT force platform-PS2141) will be used to analyze the patient's data for standing postural control. This platform has shown good reliability and validity. It will be measured with participants standing barefoot and blindfolded on a force plate for 75s. To test the effect of disruption of proprioception at the calf and lower back, the task will be repeated with vibrators (~ 60 Hz, 1 mm amplitude) attached bilaterally over the Achilles tendon and lumbar paraspinal muscles, separately, in random order. Vibrators will be switched on for 15 s at ~ 15 s after the start of the trial. Coordinates of CoP will be recorded
0 weeks
Force Platform
Time Frame: 8 weeks
Force platform (Pasco PASPORT force platform-PS2141) will be used to analyze the patient's data for standing postural control. This platform has shown good reliability and validity. It will be measured with participants standing barefoot and blindfolded on a force plate for 75s. To test the effect of disruption of proprioception at the calf and lower back, the task will be repeated with vibrators (~ 60 Hz, 1 mm amplitude) attached bilaterally over the Achilles tendon and lumbar paraspinal muscles, separately, in random order. Vibrators will be switched on for 15 s at ~ 15 s after the start of the trial. Coordinates of CoP will be recorded
8 weeks
Force Platform
Time Frame: 16 weeks
Force platform (Pasco PASPORT force platform-PS2141) will be used to analyze the patient's data for standing postural control. This platform has shown good reliability and validity. It will be measured with participants standing barefoot and blindfolded on a force plate for 75s. To test the effect of disruption of proprioception at the calf and lower back, the task will be repeated with vibrators (~ 60 Hz, 1 mm amplitude) attached bilaterally over the Achilles tendon and lumbar paraspinal muscles, separately, in random order. Vibrators will be switched on for 15 s at ~ 15 s after the start of the trial. Coordinates of CoP will be recorded
16 weeks
Force Platform
Time Frame: 24 weeks
Force platform (Pasco PASPORT force platform-PS2141) will be used to analyze the patient's data for standing postural control. This platform has shown good reliability and validity. It will be measured with participants standing barefoot and blindfolded on a force plate for 75s. To test the effect of disruption of proprioception at the calf and lower back, the task will be repeated with vibrators (~ 60 Hz, 1 mm amplitude) attached bilaterally over the Achilles tendon and lumbar paraspinal muscles, separately, in random order. Vibrators will be switched on for 15 s at ~ 15 s after the start of the trial. Coordinates of CoP will be recorded
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KRL Hospital, Islamabad

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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