Low Back PainNCT04148144
Low Back Pain Among Care-seeking Families in General Practice
An observational study of Low Back Pain, run by Aalborg University at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 8 to 19 years
- Conditions the study is for
- Low Back Pain
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Oct 2019to 20 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 19 years
- All sexes
- Child, Adult
Study population: Adolescents with low back pain in Danish general practice and their parents.
Who may be able to join
- 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
Who cannot join
- not providing informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for General Practice at Aalborg University
Aalborg, Northern Jutland, 9000
About this study
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
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.
Read more
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.
- Conditions
- Low Back Pain
- Being tested
- No intervention included
- Keywords
- Low back pain, Adolescent, Parent, Prognosis, General practice
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention includedOther
No intervention included
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with low back pain | Adolescents aged 8-19 with low back pain. Receives: 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. Receives: Other: No intervention included |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 month
Secondary outcomes (10)
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.
Measured: At baseline and after 12 month
LBP affecting participation in usual daily activities
Response: yes/no. Only the adolescents with LBP from the primary cohort is asked this question.
Measured: At baseline and every month for 12 month
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.
Measured: At baseline and after 12 month
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.
Measured: At baseline and after 12 month
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.
Measured: At baseline and every month for 12 month
Sleep
Question: How many hours do you sleep on average during the night? Response: hours/night Both adolescents and parents are asked this question.
Measured: At baseline and every month for 12 month
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.
Measured: At baseline and every month for 12 month
LBP within the week prior to being enrolled in the study
Response: yes/no
Only parents from the parallel cohort is asked this question.
Measured: At baseline
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.
Measured: At baseline
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start18 Oct 2019
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- University College of Northern Denmark
- Responsible party
- Principal investigator, Christian Lund Straszek, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148144
- Sponsor's protocol ID
- The YoungBack Project
- Status last verified
- Jul 2022
- First submitted
- 24 Oct 2019
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04148144
- Acronym / sponsor ID
- The YoungBack Project
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Adolescent, Parent, Prognosis, General practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- University College of Northern Denmark
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents with low back pain | – | Other: No intervention includedAdolescents aged 8-19 with low back pain. |
| Parents of included adolescents | – | Other: No intervention includedParents 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. |
Who may qualify
- Ages
- 8 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Adolescents with low back pain in Danish general practice and their parents.
Key inclusion criteria (5 listed)
- age between 8 and 19
- experiencing low back pain
- parent or legal guardian of included adolescents
Key exclusion criteria (1 listed)
- not providing informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention includedNo intervention included | Other | Adolescents with low back pain, Parents of included adolescents |
Primary outcome
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.
10 secondary outcomes
LBP frequency
Time frame: At baseline and after 12 month
LBP affecting participation in usual daily activities
Time frame: At baseline and every month for 12 month
Health-related quality of life - psychologic wellbeing
Time frame: At baseline and after 12 month
Health-related quality of life - moods and emotions
Time frame: At baseline and after 12 month
Illness perception (adolescent)
Time frame: At baseline and every month for 12 month
Sleep
Time frame: At baseline and every month for 12 month
Pain interference
Time frame: At baseline and every month for 12 month
LBP within the week prior to being enrolled in the study
Time frame: At baseline
Health-related quality of life (parent)
Time frame: At baseline
Illness perception (parent)
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worst low back pain during the week prior to consulting the general practitioner. (time frame: At 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.