Age Bias on Biopsychosocial Factors in Persons With Non-specific Low Back Pain.

Not Applicable

Recruiting

• Conditions: Low Back Pain
• Interventions: Other: Symptom Modulation Approach, Movement Control Approach, Functional Optimization Approach

• Registration Number: NCT05111782
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-08
• Study Start: 2022-06-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-03-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. Both male & Female patients
2. Age group 20-60 Years
3. 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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Symptom Modulation Approach, Movement Control Approach, Functional Optimization Approach	The treatment group will consist of persons with low back pain. This group will be further divided into groups for each decade.

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	6 months	The Numeric Pain Rating Scale will be used to quantify pain intensity on a scale of 1-10. A higher score represents higher pain.
Fear Avoidance Belief Questionnaire (FABQ)	6 months	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	6 months	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).
Pittsburgh Sleep Quality Index (PSQI)	6 months	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.
Heart rate variability	6 months	Heart rate variability will be assessed through Smartwatch.
Keele STarT Back Screening Tool	6 months	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	6 months	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
Center for Epidemiological Studies-Depression Scale (CES-D)	6 months	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.
Gait & Balance mobile Application	6 months	This mobile application will be used to measure the balance of the participants.
International Physical Activity Questionnaire (IPAQ)	6 months	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	6 months	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.
Force Platform	6 months	Standing postural control will be assessed using Force Platform.Coordinates of Centre of Pressure will be recorded.
Örebro Musculoskeletal Pain Screening Questionnaire	6 months	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.
Roland Morris Disability Questionnaire (RMDQ)	6 months	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.
Activity level	6 months	Activity level will be assessed through Smartwatch in the form of the number of steps per day.
Sleep pattern	6 months	Sleep patterns will be assessed through Smartwatch in the form of phases of sleep and duration of sleep.
Pain self-efficacy Questionnaire (PSEQ)	6 months	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.

Trial Locations

Locations (1)

Foundation university institute of rehabilitation sciences; 🇵🇰 Islamabad, Federal, Pakistan