Back and Neck Pain in Adolescence | NCT02955342

Studies
Back and Neck Pain in Adolescence

NCT02955342

Sponsor

Balgrist University Hospital

Status

Completed

Last Update Posted

Apr 30, 2020Actual

Enrollment

244Actual

Phase

Not provided

Conditions

Back Pain

Interventions

no intervention

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Dec 7, 2019Actual

Completion Date

Dec 7, 2019Actual

First Submitted Date

Oct 6, 2016

First Submission Date that Met QC Criteria

Nov 3, 2016

First Posted Date

Nov 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2020

Last Update Posted Date

Apr 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

244Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in a German Version of the Young Spine Questionnaire		change from baseline to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

10 to 16 years old

Exclusion Criteria:

younger than 10, older than 16

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Adolescents between 10 and 16 years with and without back and neck pain.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barry K Humphreys, Professor	Balgrist University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Balgrist University Hospital		Zurich		8008	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23758965	Background	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.
24094041	Background	Wirth 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.

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms