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Completed

NCT Number: NCT04148144

Low Back Pain Among Care-seeking Families in General Practice

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.

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Key information

Conditions

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

Age range

8 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for General Practice at Aalborg University

Aalborg, Northern Jutland, 9000, Denmark

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention included

Other

No intervention included

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. LBP affecting participation in usual daily activities

    Time frame: At baseline and every month for 12 month

    Response: yes/no. Only the adolescents with LBP from the primary cohort is asked this question.

  3. 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.

  4. 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.

  5. Illness perception (adolescent)

    Time frame: At baseline and every month for 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.

  6. Sleep

    Time frame: At baseline and every month for 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.

  7. Pain interference

    Time frame: At baseline and every month for 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • University College of Northern Denmark

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2019
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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