An interventional study of Symptom Modulation Approach, Movement Control Approach, Functional Optimization Approach in Low Back Pain, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Riphah International University · Not applicable, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 280 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.
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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.
The treatment group will consist of persons with low back pain. This group will be further divided into groups for each decade.
Other: Symptom Modulation Approach, Movement Control Approach, Functional Optimization Approach
The control group will consist of healthy controls. This group will be further divided into groups for each decade.
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.
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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
Time frame: 6 months
Gait & Balance mobile Application
This mobile application will be used to measure the balance of the participants.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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).
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
Force Platform
Standing postural control will be assessed using Force Platform.Coordinates of Centre of Pressure will be recorded.
Time frame: 6 months
Heart rate variability
Heart rate variability will be assessed through Smartwatch.
Time frame: 6 months
Sleep pattern
Sleep patterns will be assessed through Smartwatch in the form of phases of sleep and duration of sleep.
Time frame: 6 months
Activity level
Activity level will be assessed through Smartwatch in the form of the number of steps per day.
Time frame: 6 months
Plan to share: No
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