Clinical trial NCT05111782: 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
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 280
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 6 months
measure: Örebro Musculoskeletal Pain Screening Questionnaire
timeFrame: 6 months
measure: Keele STarT Back Screening Tool
timeFrame: 6 months
measure: Low Back Outcome Scale
timeFrame: 6 months
measure: Gait & Balance mobile Application
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 months
measure: Center for Epidemiological Studies-Depression Scale (CES-D)
timeFrame: 6 months
measure: Fear Avoidance Belief Questionnaire (FABQ)
timeFrame: 6 months
measure: Job Content Questionnaire
timeFrame: 6 months
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: 6 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 6 months
measure: Pain catastrophizing scale
timeFrame: 6 months
measure: Pain self-efficacy Questionnaire (PSEQ)
timeFrame: 6 months
measure: Force Platform
timeFrame: 6 months
measure: Heart rate variability
timeFrame: 6 months
measure: Sleep pattern
timeFrame: 6 months
measure: Activity level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation university institute of rehabilitation sciences
state: Federal
Study officials:
affiliation: Riphah International University
name: Imran Amjad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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. doi: 10.1016/S0140-6736(19)31047-5.
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.
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.