Low Back Pain Among Care-seeking Families in General Practice

Completed

• Conditions: Low Back Pain
• Interventions: Other: No intervention included

• Registration Number: NCT04148144
• Lead Sponsor: Aalborg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-18
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-01
• Primary Completion: 2021-08-20
• Study Completion: 2021-08-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adolescents with low back pain	No intervention included	Adolescents aged 8-19 with low back pain.
Parents of included adolescents	No intervention included	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.

Primary Outcome Measures

Name	Time	Method
Worst low back pain during the week prior to consulting the general practitioner.	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 Outcome Measures

Name	Time	Method
LBP frequency	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.
Illness perception (adolescent)	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.
Illness perception (parent)	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.
LBP affecting participation in usual daily activities	At baseline and every month for 12 month	Response: yes/no. Only the adolescents with LBP from the primary cohort is asked this question.
Pain interference	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.
Health-related quality of life - psychologic wellbeing	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.
Health-related quality of life - moods and emotions	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.
Sleep	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.
LBP within the week prior to being enrolled in the study	At baseline	Response: yes/no; Only parents from the parallel cohort is asked this question.
Health-related quality of life (parent)	At baseline	Euroqol 5 dimensions 5 levels (EQ-5D-5L) questionnaire; Only parents from the parallel cohort is asked these question.

Trial Locations

Locations (1)

Center for General Practice at Aalborg University; 🇩🇰 Aalborg, Northern Jutland, Denmark