Low Back Pain Among Care-seeking Families in General Practice

Overview

Background Low back pain (LBP) is the largest cause of years lived with disability worldwide and often associated with low quality of life, inability to work and low physical activity levels. In Danish general practice, LBP accounts for nearly 10% of all yearly consultations, making it the number one reason for consulting a general practitioner in Denmark. An increase in care-seeking children and adolescents with LBP in general practice is seen in the pre-teen-age-years.

At present, no study has investigated on the natural prognosis of LBP among care-seeking adolescents in general practice. Furthermore, the potential impact of patient and parent-related factors on prognosis remains unknown. The aims of the study are to 1) investigate the natural prognosis of LBP and 2) identify patient and parent-related factors which my influence prognosis.

Methods Adolescents aged 8 to 19 years consulting their general practitioner due to LBP will be invited to participate in this prospective cohort study. One parent of each patient will be invited to be a part of the parallel cohort. Online questionnaires will be used to collect data on patient characterises, pain intensity, pain frequency, medication, health-related quality of life, physical activity and illness perception at baseline and at the one-year follow-up. Data on pain intensity and parent-related worries will be collected through biweekly text messages. LBP will be assessed by latent class analysis.

Discussion This study will be the first to uncover the natural prognosis of LBP within a young, care-seeking population in general practice and to investigate if factors related to the patient or parents influence prognosis.

Full Title of Study: “Low Back Pain Among Care-seeking Families in General Practice (The YoungBack Project): a Prospective Parallel Cohort Study in 400 Children and Adolescents and Their Parents”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 30, 2021

Interventions

  • Other: No intervention included
    • No intervention included

Arms, Groups and Cohorts

  • Adolescents with low back pain
    • Adolescents aged 8-19 with low back pain.
  • Parents of included adolescents
    • Parents recruited for the parallel cohort, are required to be a parent or a legal guardian of the included adolescent. Siblings, grandparents or a similar person are not eligible for inclusion in the parallel cohort.

Clinical Trial Outcome Measures

Primary Measures

  • Worst low back pain during the week prior to consulting the general practitioner.
    • Time Frame: At 12 month
    • Is measured on an 100mm visual analogue scale (0mm equals no pain and 100mm equals worst possible pain). Only the adolescents with LBP from the primary cohort is asked this question.

Secondary Measures

  • LBP frequency
    • Time Frame: At baseline and after 12 month
    • Response: 5-point Likert scale (daily, several times per week, weekly, monthly, rarely). Only the adolescents with LBP from the primary cohort is asked this question.
  • LBP affecting participation in usual daily activities
    • Time Frame: At baseline and after 12 month
    • Response: yes/no. Only the adolescents with LBP from the primary cohort is asked this question.
  • Health-related quality of life – psychologic wellbeing
    • Time Frame: At baseline and after 12 month
    • Question: “Have you felt satisfied with your life?” Response: not at all, slightly, moderately, very and extremely Only the adolescents with LBP from the primary cohort is asked this question.
  • Health-related quality of life – moods and emotions
    • Time Frame: At baseline and after 12 month
    • Question: Have you felt under pressure? Response: never, seldom, quite often, very often, always Only the adolescents with LBP from the primary cohort is asked this question.
  • Illness perception (adolescent)
    • Time Frame: At baseline and after 12 month
    • Question: Are you worried about your back pain? Response: 10-point scale with 0 being equal to “not worried at all” whereas 10 will be equal to “very worried”. Only the adolescents with LBP from the primary cohort is asked this question.
  • Sleep
    • Time Frame: At baseline and after 12 month
    • Question: How many hours do you sleep on average during the night? Response: hours/night Both adolescents and parents are asked this question.
  • Pain interference
    • Time Frame: At baseline and after 12 month
    • Response: I have no problems doing my usual activities, I have slight problems doing my usual activities, I have moderate problems doing my usual activities, I have severe problems doing my usual activities or I have extreme problems doing my usual activities. Only the adolescents with LBP from the primary cohort is asked this question.
  • LBP within the week prior to being enrolled in the study
    • Time Frame: At baseline
    • Response: yes/no Only parents from the parallel cohort is asked this question.
  • Health-related quality of life (parent)
    • Time Frame: At baseline
    • Euroqol 5 dimensions 5 levels (EQ-5D-5L) questionnaire Only parents from the parallel cohort is asked these question.
  • Illness perception (parent)
    • Time Frame: At baseline
    • Question: Are you worried about your child’s back pain? Response: 10-point scale with 0 being equal to “not worried at all” whereas 10 will be equal to “very worried”. Only parents from the parallel cohort is asked this question.
  • Biweekly pain rating
    • Time Frame: From two weeks after inclusion and every second week for 52 weeks
    • Biweekly pain ratings will be assessed through text messages with the following question: On a scale from 0 to 10, with 0 indicating no pain at all, and 10 indicating the worst pain imaginable, how much pain did you/your child have in the lower back during the last week when the pain was at its worst? Adolescent older than 18 years of age will receive the text messages themselves. For adolescents younger than 18 years of age, a parent will receive the text messages.
  • Biweekly assessment of LBP limitations
    • Time Frame: From two weeks after inclusion and every second week for 52 weeks
    • Biweekly assessment of LBP limitations will be assessed through text messages with the following question: Are you/Is your child limited during the day because of low back pain? Adolescent older than 18 years of age will receive the text messages themselves. For adolescents younger than 18 years of age, a parent will receive the text messages.

Participating in This Clinical Trial

Inclusion Criteria

For adolescents in the primary cohort:

  • age between 8 and 19
  • experiencing low back pain

For parents in the parallel cohort:

  • parent or legal guardian of included adolescents

Exclusion Criteria

  • not providing informed consent.

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 19 Years

Investigator Details

  • Lead Sponsor
    • Aalborg University
  • Collaborator
    • University College of Northern Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christian Lund Straszek, Principal Investigator – Aalborg University
  • Overall Contact(s)
    • Christian LN Straszek, M.Sc., +45 50 54 78 18, cst@dcm.aau.dk

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