NCT04148144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

1.8 years

First QC Date

October 24, 2019

Last Update Submit

July 13, 2022

Conditions

Low Back Pain

Keywords

Low back painAdolescentParentPrognosisGeneral practice

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • LBP frequency

    At baseline and after 12 month

  • LBP affecting participation in usual daily activities

    At baseline and every month for 12 month

  • Health-related quality of life - psychologic wellbeing

    At baseline and after 12 month

  • Health-related quality of life - moods and emotions

    At baseline and after 12 month

  • Illness perception (adolescent)

    At baseline and every month for 12 month

  • +5 more secondary outcomes

Study Arms (2)

Adolescents with low back pain

Adolescents aged 8-19 with low back pain.

Other: No intervention included

Parents of included adolescents

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.

Other: No intervention included

Interventions

No intervention includedOTHER

No intervention included

Adolescents with low back painParents of included adolescents

Eligibility Criteria

Age8 Years - 19 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents with low back pain in Danish general practice and their parents.

You may qualify if:

  • 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

You may not qualify if:

  • \- not providing informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for General Practice at Aalborg University

Aalborg, Northern Jutland, 9000, Denmark

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2019

First Posted

November 1, 2019

Study Start

October 18, 2019

Primary Completion

August 20, 2021

Study Completion

August 20, 2021

Last Updated

July 14, 2022

Record last verified: 2022-07

Locations

DK(1)