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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04148144
Enrollment
13
Registered
2019-11-01
Start date
2019-10-18
Completion date
2021-08-20
Last updated
2022-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Low back pain, Adolescent, Parent, Prognosis, General practice

Brief summary

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.

Interventions

No intervention included

Sponsors

University College of Northern Denmark
CollaboratorOTHER
Aalborg University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 19 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Worst low back pain during the week prior to consulting the general practitioner.At 12 monthIs 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

MeasureTime frameDescription
LBP affecting participation in usual daily activitiesAt baseline and every month for 12 monthResponse: yes/no. Only the adolescents with LBP from the primary cohort is asked this question.
Health-related quality of life - psychologic wellbeingAt baseline and after 12 monthQuestion: 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 emotionsAt baseline and after 12 monthQuestion: 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)At baseline and every month for 12 monthQuestion: 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.
LBP frequencyAt baseline and after 12 monthResponse: 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.
Illness perception (parent)At baselineQuestion: 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.
Pain interferenceAt baseline and every month for 12 monthResponse: 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 studyAt baselineResponse: yes/no Only parents from the parallel cohort is asked this question.
Health-related quality of life (parent)At baselineEuroqol 5 dimensions 5 levels (EQ-5D-5L) questionnaire Only parents from the parallel cohort is asked these question.
SleepAt baseline and every month for 12 monthQuestion: How many hours do you sleep on average during the night? Response: hours/night Both adolescents and parents are asked this question.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026