Age Bias on Biopsychosocial Factors in Persons With Non-specific Low Back Pain.
Primary Purpose
Low Back Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Symptom Modulation Approach, Movement Control Approach, Functional Optimization Approach
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Both male & Female patients
- Age group 20-60 Years
- Diagnosed with nonspecific low back pain for more than 3 months (i.e., pain localized below the costal margin and above the inferior gluteal folds with or without referred leg pain of a nociceptive mechanical nature, not attributable to a recognizable, known specific spinal pathology, for a period of at least twelve weeks)
Exclusion Criteria:
Any serious conditions like neurological conditions which would not allow the patient to fill the questionnaire independently, any infection, tumor, spinal surgery, cognitive impairments, or any other rheumatologic disease would be excluded.
Sites / Locations
- Foundation university institute of rehabilitation sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Group
Healthy Control Group
Arm Description
The treatment group will consist of persons with low back pain. This group will be further divided into groups for each decade.
The control group will consist of healthy controls. This group will be further divided into groups for each decade.
Outcomes
Primary Outcome Measures
Numeric Pain Rating Scale
The Numeric Pain Rating Scale will be used to quantify pain intensity on a scale of 1-10. A higher score represents higher pain.
Örebro Musculoskeletal Pain Screening Questionnaire
Screening for long term disability and failure to return to work will be done through Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ). The total score will range between 1 and 100. A higher score represents a poor outcome.
Keele STarT Back Screening Tool
Screening for primary care patients with low back pain to look for prognostic indicators that are relevant to initial decision making will be done through Keele STarT Back Screening Tool (SBST). Scores range from 0-9 and are produced by adding all positive items; patients who achieve a score of 0-3 are classified into the low-risk subgroup and those with scores of 4-9 into the medium-risk subgroup.
Low Back Outcome Scale
Pain & physical function will be assessed through the Low Back Outcome Scale. The Low Back Outcome Scale ranges from 0 to 75 and the higher score indicates better condition
Gait & Balance mobile Application
This mobile application will be used to measure the balance of the participants.
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality and disturbances will be assessed through Pittsburgh Sleep Quality Index (PSQI). The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The sub-scores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Center for Epidemiological Studies-Depression Scale (CES-D)
Depression symptoms will be evaluated through CES-D. The possible range is 0-60. If more than four questions are missing answers, do not score the CES-D questionnaire. A score of 16 points or more is considered depressed. The possible range is 0-60. A score of 16 points or more is considered depressed.
Fear Avoidance Belief Questionnaire (FABQ)
Fear of pain will be evaluated through FABQ. The score range is between 0 to 96. A higher score indicates strongly held fear-avoidance beliefs.
Job Content Questionnaire
Psychosocial aspects related to the job will be evaluated through the Job Content Questionnaire. The items are quantified on a four-point Likert scale ranging from 1 (totally disagree) to 4 (totally agree).
Roland Morris Disability Questionnaire (RMDQ)
Physical disability due to low back pain will be evaluated through RMDQ. The score can range from 0 to 24. A higher score indicates greater disability.
International Physical Activity Questionnaire (IPAQ)
Physical activity levels will be assessed through IPAQ. Data collected with IPAQ will be reported as a continuous measure and reported as median METminutes. walking is considered to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. A higher score indicates higher levels of physical activity.
Pain catastrophizing scale
Catastrophic thinking related to pain will be evaluated through the pain catastrophizing scale. It consists of 13 items scored from 0 to 4, resulting in a total possible score of 52. A higher score indicates a higher level of catastrophizing.
Pain self-efficacy Questionnaire (PSEQ)
Confidence in dealing with pain will be evaluated through PSEQ. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain.
Force Platform
Standing postural control will be assessed using Force Platform.Coordinates of Centre of Pressure will be recorded.
Heart rate variability
Heart rate variability will be assessed through Smartwatch.
Sleep pattern
Sleep patterns will be assessed through Smartwatch in the form of phases of sleep and duration of sleep.
Activity level
Activity level will be assessed through Smartwatch in the form of the number of steps per day.
Secondary Outcome Measures
Full Information
NCT ID
NCT05111782
First Posted
October 7, 2021
Last Updated
February 4, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05111782
Brief Title
Age Bias on Biopsychosocial Factors in Persons With Non-specific Low Back Pain.
Official Title
Age Bias on Biopsychosocial Factors in Persons With Non-specific Low Back Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 20, 2022 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Low back pain is a debilitating condition experienced by people of all age groups. This study will be completed in two stages in which back pain assessment tools will be first translated to Urdu language and later on age-related bias on biopsychosocial factors will be assessed using various biopsychosocial tools over a period of six months.
Detailed Description
Low back pain (LBP) is an extremely common symptom experienced by people of all ages. The current incidence, prevalence and disability-adjusted life years (DALYs) account for 245.9 million cases/year (15th worldwide cause; 32.4% cases associated with leg pain), 577.0 million cases (15th worldwide cause) and 64.9 million DALYs (6th worldwide cause), respectively. In recent decades, the biopsychosocial model has been applied as a framework for understanding the complexity of low back pain disability in preference to a purely biomedical approach. Considering the large population of patients with LBP and limited medical resources, the development of brief and efficient prognostic clinical tools for use in routine practice is particularly significant. Recent data from epidemiological studies suggest that LBP could affect the physical function of young and older individuals differently. The age-related differ¬ences in the prevalence of some low back pathologies may explain the differential treatment outcomes. The aim of the study is to explore the age bias on biopsychosocial factors in persons with non-specific low back pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
The treatment group will consist of persons with low back pain. This group will be further divided into groups for each decade.
Arm Title
Healthy Control Group
Arm Type
No Intervention
Arm Description
The control group will consist of healthy controls. This group will be further divided into groups for each decade.
Intervention Type
Other
Intervention Name(s)
Symptom Modulation Approach, Movement Control Approach, Functional Optimization Approach
Intervention Description
Based on the patients' symptoms and level of disability, either symptom modulation or movement control or functional optimization exercises will be used. The exercises will be provided on alternate days for a duration of 30 minutes in each session preceded by electrotherapeutic modalities for pain relief and muscle relaxation. These modalities will be given for 15 min in each session. The total no. of sessions will be based on the patient's progress for a maximum of 4 weeks.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
The Numeric Pain Rating Scale will be used to quantify pain intensity on a scale of 1-10. A higher score represents higher pain.
Time Frame
6 months
Title
Örebro Musculoskeletal Pain Screening Questionnaire
Description
Screening for long term disability and failure to return to work will be done through Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ). The total score will range between 1 and 100. A higher score represents a poor outcome.
Time Frame
6 months
Title
Keele STarT Back Screening Tool
Description
Screening for primary care patients with low back pain to look for prognostic indicators that are relevant to initial decision making will be done through Keele STarT Back Screening Tool (SBST). Scores range from 0-9 and are produced by adding all positive items; patients who achieve a score of 0-3 are classified into the low-risk subgroup and those with scores of 4-9 into the medium-risk subgroup.
Time Frame
6 months
Title
Low Back Outcome Scale
Description
Pain & physical function will be assessed through the Low Back Outcome Scale. The Low Back Outcome Scale ranges from 0 to 75 and the higher score indicates better condition
Time Frame
6 months
Title
Gait & Balance mobile Application
Description
This mobile application will be used to measure the balance of the participants.
Time Frame
6 months
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Sleep quality and disturbances will be assessed through Pittsburgh Sleep Quality Index (PSQI). The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The sub-scores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Time Frame
6 months
Title
Center for Epidemiological Studies-Depression Scale (CES-D)
Description
Depression symptoms will be evaluated through CES-D. The possible range is 0-60. If more than four questions are missing answers, do not score the CES-D questionnaire. A score of 16 points or more is considered depressed. The possible range is 0-60. A score of 16 points or more is considered depressed.
Time Frame
6 months
Title
Fear Avoidance Belief Questionnaire (FABQ)
Description
Fear of pain will be evaluated through FABQ. The score range is between 0 to 96. A higher score indicates strongly held fear-avoidance beliefs.
Time Frame
6 months
Title
Job Content Questionnaire
Description
Psychosocial aspects related to the job will be evaluated through the Job Content Questionnaire. The items are quantified on a four-point Likert scale ranging from 1 (totally disagree) to 4 (totally agree).
Time Frame
6 months
Title
Roland Morris Disability Questionnaire (RMDQ)
Description
Physical disability due to low back pain will be evaluated through RMDQ. The score can range from 0 to 24. A higher score indicates greater disability.
Time Frame
6 months
Title
International Physical Activity Questionnaire (IPAQ)
Description
Physical activity levels will be assessed through IPAQ. Data collected with IPAQ will be reported as a continuous measure and reported as median METminutes. walking is considered to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. A higher score indicates higher levels of physical activity.
Time Frame
6 months
Title
Pain catastrophizing scale
Description
Catastrophic thinking related to pain will be evaluated through the pain catastrophizing scale. It consists of 13 items scored from 0 to 4, resulting in a total possible score of 52. A higher score indicates a higher level of catastrophizing.
Time Frame
6 months
Title
Pain self-efficacy Questionnaire (PSEQ)
Description
Confidence in dealing with pain will be evaluated through PSEQ. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain.
Time Frame
6 months
Title
Force Platform
Description
Standing postural control will be assessed using Force Platform.Coordinates of Centre of Pressure will be recorded.
Time Frame
6 months
Title
Heart rate variability
Description
Heart rate variability will be assessed through Smartwatch.
Time Frame
6 months
Title
Sleep pattern
Description
Sleep patterns will be assessed through Smartwatch in the form of phases of sleep and duration of sleep.
Time Frame
6 months
Title
Activity level
Description
Activity level will be assessed through Smartwatch in the form of the number of steps per day.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Both male & Female patients
Age group 20-60 Years
Diagnosed with nonspecific low back pain for more than 3 months (i.e., pain localized below the costal margin and above the inferior gluteal folds with or without referred leg pain of a nociceptive mechanical nature, not attributable to a recognizable, known specific spinal pathology, for a period of at least twelve weeks)
Exclusion Criteria:
Any serious conditions like neurological conditions which would not allow the patient to fill the questionnaire independently, any infection, tumor, spinal surgery, cognitive impairments, or any other rheumatologic disease would be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aamer Naeem, MS
Phone
+923229781038
Email
aamerr.naeem@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
+923324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran Amjad, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation university institute of rehabilitation sciences
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aamer Naeem, MS
Phone
03229781038
Email
aamerr.naeem@gmail.com
First Name & Middle Initial & Last Name & Degree
Aamer Naeem, MS
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22231424
Citation
Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
Results Reference
background
PubMed Identifier
12748896
Citation
Hartvigsen J, Christensen K, Frederiksen H. Back pain remains a common symptom in old age. a population-based study of 4486 Danish twins aged 70-102. Eur Spine J. 2003 Oct;12(5):528-34. doi: 10.1007/s00586-003-0542-y. Epub 2003 May 14.
Results Reference
background
PubMed Identifier
30854609
Citation
Urits I, Burshtein A, Sharma M, Testa L, Gold PA, Orhurhu V, Viswanath O, Jones MR, Sidransky MA, Spektor B, Kaye AD. Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment. Curr Pain Headache Rep. 2019 Mar 11;23(3):23. doi: 10.1007/s11916-019-0757-1.
Results Reference
background
PubMed Identifier
27745712
Citation
Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
Results Reference
background
PubMed Identifier
30496104
Citation
GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. Erratum In: Lancet. 2019 Jun 22;393(10190):e44.
Results Reference
background
PubMed Identifier
23016055
Citation
Hebert JJ, Koppenhaver SL, Walker BF. Subgrouping patients with low back pain: a treatment-based approach to classification. Sports Health. 2011 Nov;3(6):534-42. doi: 10.1177/1941738111415044.
Results Reference
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PubMed Identifier
16395181
Citation
Fritz JM, Brennan GP, Clifford SN, Hunter SJ, Thackeray A. An examination of the reliability of a classification algorithm for subgrouping patients with low back pain. Spine (Phila Pa 1976). 2006 Jan 1;31(1):77-82. doi: 10.1097/01.brs.0000193898.14803.8a.
Results Reference
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Age Bias on Biopsychosocial Factors in Persons With Non-specific Low Back Pain.
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