Low Back Pain Among Care-seeking Families in General Practice

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: No intervention included

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• Denmark
  • Northern Jutland
    • Aalborg, Northern Jutland, Denmark, 9000
      • Center for General Practice at Aalborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adolescents with low back pain in Danish general practice and their parents.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adolescents with low back pain; Adolescents aged 8-19 with low back pain.	Other: No intervention included; No intervention included
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.	Other: No intervention included; No intervention included

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worst low back pain during the week prior to consulting the general practitioner.	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.	At 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LBP frequency	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.	At baseline and after 12 month
LBP affecting participation in usual daily activities	Response: yes/no. Only the adolescents with LBP from the primary cohort is asked this question.	At baseline and every month for 12 month
Health-related quality of life - psychologic wellbeing	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.	At baseline and after 12 month
Health-related quality of life - moods and emotions	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.	At baseline and after 12 month
Illness perception (adolescent)	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.	At baseline and every month for 12 month
Sleep	Question: How many hours do you sleep on average during the night? Response: hours/night Both adolescents and parents are asked this question.	At baseline and every month for 12 month
Pain interference	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.	At baseline and every month for 12 month
LBP within the week prior to being enrolled in the study	Response: yes/no Only parents from the parallel cohort is asked this question.	At baseline
Health-related quality of life (parent)	Euroqol 5 dimensions 5 levels (EQ-5D-5L) questionnaire Only parents from the parallel cohort is asked these question.	At baseline
Illness perception (parent)	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.	At baseline

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: University College of Northern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Actual): August 20, 2021
• Study Completion (Actual): August 20, 2021

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Adolescent; Prognosis; Low back pain; General practice; Parent
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: The YoungBack Project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No