Low Back Pain Among Care-seeking Families in General Practice

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148144
• Other study ID #: The YoungBack Project
• Status: Completed
• Start date: October 18, 2019
• Est. completion date: August 20, 2021

Study information

• Verified date: July 2022
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Gender: All
• Age group: 8 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• No intervention included
No intervention included

Locations

Country	Name	City	State
Denmark	Center for General Practice at Aalborg University	Aalborg	Northern Jutland

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University	University College of Northern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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