Back PainYoungbackNCT02955342
Back and Neck Pain in Adolescence
An observational study of Back Pain, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
To validate the German version of the Young Spine Questionnaire (G-YSQ) and to study back and neck pain in adolescents between 10 and 16 years during one year by means of G-YSQ. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- How many people
- 244 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2016to 7 Dec 2019
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescents between 10 and 16 years with and without back and neck pain.
Who may be able to join
- 10 to 16 years old
Who cannot join
- younger than 10, older than 16
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Back and Neck Pain in Adolescence: A Prospective Cohort Study Using a German Version of the Young Spine Questionnaire
To validate the German version of the Young Spine Questionnaire (G-YSQ) and to study back and neck pain in adolescents between 10 and 16 years during one year by means of G-YSQ.
Read the detailed description
In two settings (school, clinics) back and neck pain of 10 to 16 years old adolescents will be assessed by the German Version of the Young Spine Questionnaire at 6 points in time during one year.
Validity, reliability and responsiveness of the G-YSQ will be determined and the development of back and neck pain within a year will be described.
- Conditions
- Back Pain
- Being tested
- no intervention
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in a German Version of the Young Spine Questionnaire
Measured: change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion7 Dec 2019
- Study completion7 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barry K Humphreys, Professor, Study director, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955342
- Sponsor's protocol ID
- 2016-00568
- Other IDs
- 2016
- Acronym
- Youngback
- Status last verified
- Apr 2020
- First submitted
- 6 Oct 2016
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lauridsen HH, Hestbaek L. Development of the young spine questionnaire. BMC Musculoskelet Disord. 2013 Jun 12;14:185. doi: 10.1186/1471-2474-14-185.
PubMed 23758965Wirth B, Knecht C, Humphreys K. Spine Day 2012: spinal pain in Swiss school children- epidemiology and risk factors. BMC Pediatr. 2013 Oct 5;13:159. doi: 10.1186/1471-2431-13-159.
PubMed 24094041Wirth B, Humphreys BK. Pain characteristics of adolescent spinal pain. BMC Pediatr. 2015 Apr 17;15:42. doi: 10.1186/s12887-015-0344-5.
PubMed 25886130Nyiro L, Potthoff T, Siegenthaler MH, Riner F, Schweinhardt P, Wirth B. Translation and validation of the German version of the Young Spine Questionnaire. BMC Pediatr. 2021 Aug 24;21(1):359. doi: 10.1186/s12887-021-02804-y.
PubMed 34429090
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back and Neck Pain in Adolescence: A Prospective Cohort Study Using a German Version of the Young Spine Questionnaire
- ClinicalTrials.gov ID
- NCT02955342
- Acronym / sponsor ID
- Youngback / 2016-00568
- Conditions
- Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 7 Dec 2019 (actual)
- Study completion
- 7 Dec 2019 (actual)
- First posted
- 4 Nov 2016 (estimated)
- 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.
To validate the German version of the Young Spine Questionnaire (G-YSQ) and to study back and neck pain in adolescents between 10 and 16 years during one year by means of G-YSQ.
Detailed description
In two settings (school, clinics) back and neck pain of 10 to 16 years old adolescents will be assessed by the German Version of the Young Spine Questionnaire at 6 points in time during one year.
Validity, reliability and responsiveness of the G-YSQ will be determined and the development of back and neck pain within a year will be described.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescents between 10 and 16 years with and without back and neck pain.
Key inclusion criteria (1 listed)
- 10 to 16 years old
Key exclusion criteria (1 listed)
- younger than 10, older than 16
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 interventionno intervention | Other | – |
Primary outcome
Changes in a German Version of the Young Spine Questionnaire
Time frame: change from baseline to 12 months
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 30 Apr 2020.
- Background: PubMed 23758965Lauridsen HH, Hestbaek L. Development of the young spine questionnaire. BMC Musculoskelet Disord. 2013 Jun 12;14:185. doi: 10.1186/1471-2474-14-185.
- Background: PubMed 24094041Wirth B, Knecht C, Humphreys K. Spine Day 2012: spinal pain in Swiss school children- epidemiology and risk factors. BMC Pediatr. 2013 Oct 5;13:159. doi: 10.1186/1471-2431-13-159.
- Background: PubMed 25886130Wirth B, Humphreys BK. Pain characteristics of adolescent spinal pain. BMC Pediatr. 2015 Apr 17;15:42. doi: 10.1186/s12887-015-0344-5.
- Derived from this study: PubMed 34429090Nyiro L, Potthoff T, Siegenthaler MH, Riner F, Schweinhardt P, Wirth B. Translation and validation of the German version of the Young Spine Questionnaire. BMC Pediatr. 2021 Aug 24;21(1):359. doi: 10.1186/s12887-021-02804-y.
- Individual participant dataSharing planned: Undecided
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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.
Barry K Humphreys, Professor study director
Balgrist University Hospital
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 Back Pain, run by Balgrist University Hospital at 1 site in Switzerland.
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 1 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 30 Apr 2020. 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 Switzerland. 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?
Changes in a German Version of the Young Spine Questionnaire (time frame: change from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02955342, which also lists 4 linked publications.
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 30 Apr 2020.