Low Back PainNCT05751499
Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain
An observational study of Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the diagnostic and prognostic blood markers in acute and chronic nonspecific low back pain with healthy controls Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- • Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2023to 31 May 2024
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: PEOPLE BETWEEN 18 TO 60 YEARS HAVING LOW BACK PAIN WITH NON SPECIFIC REASON
Who may be able to join
- Both male \& Female patients
- Age group 18-60 Years
- Diagnosed with nonspecific low back pain in acute/flared stage
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
KRL Hospital
Islamabad, 44000
Rana M Tahir, PhD*, 03333727189, phyranamuhammadtahir@gmail.com
Rana Muhammad Tahir, PhD*
About this study
- To compare the diagnostic and prognostic blood markers in acute and chronic nonspecific low back pain with healthy controls
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- • Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
• Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGENDiagnostic test
- 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
| Study group | Role | What they receive |
|---|---|---|
| CASE GROUP | 1. Both male \& Female patients
2. Age group 18-60 Years
3. Diagnosed with nonspecific low back pain in acute/flared stage Receives: Diagnostic Test: • Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN | |
| CONTROL GROUP | MALE AND FEMALE AGE GROUP 18 TO 60 YEARS NOT SUFFERING FROM LOW BACK PAIN Receives: Diagnostic Test: • Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 24th weeks
TNF ALPHA
TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
Measured: 0 weeks
TNF ALPHA
TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
Measured: 8 weeks
TNF ALPHA
TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
Measured: 16 weeks
TNF ALPHA
TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 weeks
IL 6
Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
Measured: 0 weeks
IL 6
Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
Measured: 8 weeks
IL 6
Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
Measured: 16 weeks
IL 6
Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
Measured: 24 weeks
IL-8
Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions
Measured: 0 weeks
IL-8
Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions
Measured: 8 weeks
IL-8
Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions
Measured: 16 weeks
IL-8
Interleukin-8 is a chemoattractant cytokine produced by variety of tissues and blood cells. It activates neutrophils in inflammatory regions
Measured: 24 weeks
IL-1 BETA
IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
Measured: 0 weeks
IL-1 BETA
IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
Measured: 8 weeks
IL-1 BETA
IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
Measured: 16 weeks
IL-1 BETA
IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Secondary outcomes (64)
Numeric rating scale
Self-reported pain intensity will be measured using an 11-point NRS ranging from "none" to "worst imaginable pain
Measured: 0 weeks
Numeric rating scale
Self-reported pain intensity will be measured using an 11-point NRS ranging from "none" to "worst imaginable pain
Measured: 8 weeks
Numeric rating scale
Self-reported pain intensity will be measured using an 11-point NRS ranging from "none" to "worst imaginable pain
Measured: 16 weeks
Numeric rating scale
Self-reported pain intensity will be measured using an 11-point NRS ranging from "none" to "worst imaginable pain
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 week
International Physical Activity Questionnaire
IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.
Measured: 0 weeks
International Physical Activity Questionnaire
IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.
Measured: 8 weeks
International Physical Activity Questionnaire
IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.
Measured: 16 weeks
International Physical Activity Questionnaire
IPAQ evaluates the health-related physical activity. Higher score indicates increased physical activity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Mar 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Collaborators
- KRL Hospital, Islamabad
- Responsible party
- Sponsor
- Investigators
- Waqar A Awan, PhD, Study director, Faculty of Rehabilitation & Allied Health Sciences, Riphah International UniversityIMRAN AMJAD, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751499
- Sponsor's protocol ID
- Rana Muhammad Tahir
- Status last verified
- Jul 2023
- First submitted
- 17 Dec 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05751499
- Acronym / sponsor ID
- Rana Muhammad Tahir
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Collaborators
- KRL Hospital, Islamabad
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To compare the diagnostic and prognostic blood markers in acute and chronic nonspecific low back pain with healthy controls
Detailed description
- To compare the diagnostic and prognostic blood markers in acute and chronic nonspecific low back pain with healthy controls
- To predict the diagnostic and prognostic blood markers on sleep, depression and anxiety in acute and chronic non specific low back pain.
- To compare the effect of physical activity with blood markers in acute and chronic non specific low back pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CASE GROUP | – | Diagnostic Test: • Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGEN1. Both male \& Female patients 2. Age group 18-60 Years 3. Diagnosed with nonspecific low back pain in acute/flared stage |
| CONTROL GROUP | – | Diagnostic Test: • Blood Markers CRP, TNFα, IL-6, IL-8, IL-1, and IL-1β AND FIBRINOGENMALE AND FEMALE AGE GROUP 18 TO 60 YEARS NOT SUFFERING FROM LOW BACK PAIN |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- PEOPLE BETWEEN 18 TO 60 YEARS HAVING LOW BACK PAIN WITH NON SPECIFIC REASON
Key inclusion criteria (3 listed)
- Both male \& Female patients
- Age group 18-60 Years
- Diagnosed with nonspecific low back pain in acute/flared stage
Key exclusion criteria (7 listed)
- Any serious conditions like neurological conditions
- Any infection
- Tumor
- Spinal Surgery
- Cognitive Impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| • 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 | Diagnostic test | CASE GROUP, CONTROL GROUP |
Primary outcome
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
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
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
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
TNF ALPHA
Time frame: 0 weeks
TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
TNF ALPHA
Time frame: 8 weeks
TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
TNF ALPHA
Time frame: 16 weeks
TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
TNF ALPHA
Time frame: 24 weeks
TNF ALPHA is an adipokine and a cytokine. It is one of the most important pro-inflammatory cytokine.
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
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
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
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
IL 6
Time frame: 0 weeks
Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
IL 6
Time frame: 8 weeks
Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
IL 6
Time frame: 16 weeks
Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
IL 6
Time frame: 24 weeks
Interleukin-6 promptly and transiently produced in response to infections and tissues injuries.
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
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
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
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
IL-1 BETA
Time frame: 0 weeks
IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
IL-1 BETA
Time frame: 8 weeks
IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
IL-1 BETA
Time frame: 16 weeks
IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
IL-1 BETA
Time frame: 24 weeks
IL-1Beta is a pro inflammatory cytokine implicated in pain, inflammation and autoimmune condition
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.
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.
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.
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.
64 secondary outcomes
Numeric rating scale
Time frame: 0 weeks
Numeric rating scale
Time frame: 8 weeks
Numeric rating scale
Time frame: 16 weeks
Numeric rating scale
Time frame: 24 weeks
Low Back outcome scale
Time frame: 0 weeks
Low Back outcome scale
Time frame: 8 weeks
Low Back outcome scale
Time frame: 16 weeks
Low Back outcome scale
Time frame: 24 weeks
Center for Epidemiological Studies-Depression Scale (CES-D):
Time frame: 0 weeks
Center for Epidemiological Studies-Depression Scale (CES-D):
Time frame: 8 weeks
Center for Epidemiological Studies-Depression Scale (CES-D):
Time frame: 16 weeks
Center for Epidemiological Studies-Depression Scale (CES-D):
Time frame: 24 weeks
Pain catastrophizing scale
Time frame: 0 weeks
Pain catastrophizing scale
Time frame: 8 weeks
Pain catastrophizing scale
Time frame: 16 weeks
Pain catastrophizing scale
Time frame: 24 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: 0 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: 8 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: 16 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: 24 weeks
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 0 weeks
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 8 weeks
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 16 weeks
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 24 weeks
Job Content Questionnaire
Time frame: 0 weeks
Job Content Questionnaire
Time frame: 8 weeks
Job Content Questionnaire
Time frame: 16 weeks
Job Content Questionnaire
Time frame: 24 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 0 week
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 week
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 16 week
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 24 week
International Physical Activity Questionnaire
Time frame: 0 weeks
International Physical Activity Questionnaire
Time frame: 8 weeks
International Physical Activity Questionnaire
Time frame: 16 weeks
International Physical Activity Questionnaire
Time frame: 24 weeks
Roland-Morris Disability Questionnaire
Time frame: 0 weeks
Roland-Morris Disability Questionnaire
Time frame: 8 weeks
Roland-Morris Disability Questionnaire
Time frame: 16 weeks
Roland-Morris Disability Questionnaire
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waqar A Awan, PhD study director
Faculty of Rehabilitation & Allied Health Sciences, Riphah International University
IMRAN AMJAD, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana M Tahir, PhD* (+923333727189, Phyranamuhammadtahir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP (time frame: 0 weeks [at the start of data]). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.