Clinical trial NCT04148144: Low Back Pain Among Care-seeking Families in General Practice
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Low back pain
Adolescent
Parent
Prognosis
General practice
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: University College of Northern Denmark
First posted: 2019-11-01
Enrollment: 13
Sex: ALL
Minimum age (years): 8
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with low back pain in Danish general practice and their parents.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Worst low back pain during the week prior to consulting the general practitioner.
timeFrame: At 12 month
Secondary outcomes:
measure: LBP frequency
timeFrame: At baseline and after 12 month
measure: LBP affecting participation in usual daily activities
timeFrame: At baseline and every month for 12 month
measure: Health-related quality of life - psychologic wellbeing
timeFrame: At baseline and after 12 month
measure: Health-related quality of life - moods and emotions
timeFrame: At baseline and after 12 month
measure: Illness perception (adolescent)
timeFrame: At baseline and every month for 12 month
measure: Sleep
timeFrame: At baseline and every month for 12 month
measure: Pain interference
timeFrame: At baseline and every month for 12 month
measure: LBP within the week prior to being enrolled in the study
timeFrame: At baseline
measure: Health-related quality of life (parent)
timeFrame: At baseline
measure: Illness perception (parent)
timeFrame: At baseline
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Center for General Practice at Aalborg University
state: Northern Jutland
Study officials:
References: