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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05111782
• Other study ID #: REC/1116 Aamer Naeem
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Riphah International University
• Contact: Aamer Naeem, MS
• Phone: +923229781038
• Email: aamerr.naeem[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: June 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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)

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Symptom Modulation Approach, Movement Control Approach, Functional Optimization Approach
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.

Locations

Country	Name	City	State
Pakistan	Foundation university institute of rehabilitation sciences	Islamabad	Federal

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	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	6 months
Primary	Gait & Balance mobile Application	This mobile application will be used to measure the balance of the participants.	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	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).	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	Force Platform	Standing postural control will be assessed using Force Platform.Coordinates of Centre of Pressure will be recorded.	6 months
Primary	Heart rate variability	Heart rate variability will be assessed through Smartwatch.	6 months
Primary	Sleep pattern	Sleep patterns will be assessed through Smartwatch in the form of phases of sleep and duration of sleep.	6 months
Primary	Activity level	Activity level will be assessed through Smartwatch in the form of the number of steps per day.	6 months