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

NCT05111782 | Recruiting

• 1 other identifier: REC/1116 Aamer Naeem
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (17)

• 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

• 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

• 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

• 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

• Gait & Balance mobile Application

  This mobile application will be used to measure the balance of the participants.

  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.

  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.

  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.

  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).

  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.

  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.

  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.

  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.

  6 months

• Force Platform

  Standing postural control will be assessed using Force Platform.Coordinates of Centre of Pressure will be recorded.

  6 months

• Heart rate variability

  Heart rate variability will be assessed through Smartwatch.

  6 months

• Sleep pattern

  Sleep patterns will be assessed through Smartwatch in the form of phases of sleep and duration of sleep.

  6 months

• Activity level

  Activity level will be assessed through Smartwatch in the form of the number of steps per day.

  6 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Healthy Control Group

NO INTERVENTION

The control group will consist of healthy controls. This group will be further divided into groups for each decade.

Interventions

Symptom Modulation Approach, Movement Control Approach, Functional Optimization Approach OTHER

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.

Treatment Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Foundation university institute of rehabilitation sciences

Islamabad, Federal, 46000, Pakistan

RECRUITING

Related Publications (7)

• 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.

  PMID: 22231424 BACKGROUND

• 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.

  PMID: 12748896 BACKGROUND

• 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.

  PMID: 30854609 BACKGROUND

• 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.

  PMID: 27745712 BACKGROUND

• 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.

  PMID: 30496104 BACKGROUND

• 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.

  PMID: 23016055 BACKGROUND

• 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.

  PMID: 16395181 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Imran Amjad, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aamer Naeem, MS

CONTACT

+923229781038; aamerr.naeem@gmail.com

Imran Amjad, PhD

CONTACT

+923324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 8, 2021
• Study Start: June 13, 2022
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)