Chiropractic Treatment of Arthrogenic Torticollis in Infa... | NCT04299139

Studies
Chiropractic Treatment of Arthrogenic Torticollis in Infants; a Retrospective Study on Outcome in 1000 Infants

NCT04299139

Sponsor

Balgrist University Hospital

Status

Completed

Last Update Posted

Jun 9, 2020Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Arthrogenic Torticollis

Interventions

chiropractic treatment

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

Jun 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 1, 2019Actual

Primary Completion Date

Apr 1, 2020Actual

Completion Date

Apr 1, 2020Actual

First Submitted Date

Mar 5, 2020

First Submission Date that Met QC Criteria

Mar 5, 2020

First Posted Date

Mar 6, 2020Actual

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

Jun 8, 2020

Last Update Posted Date

Jun 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Patient data is collected from previously treated patients and entered into the Research Electronic Data Capture (REDCap).

Detailed Description

Already collected patient data (1995-2013) from a privat practice, is screened and entered into a individually design REDCap form.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

9 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
chiropractic treatment	Other	There is no intervention. Data that has been collected during the time a patient was attending a chiropractor. This data will be evaluated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment outcome	Subjective treatment outcome after chiropractic care	3-12 month of age

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

arthrogenic torticollis
male or female age 3-12 month
treatment was conducted between 01/1995-12/2013

Exclusion Criteria:

uncompleted record
decline of further use of patient data

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

12 Months

Standard Ages

Child

Study Population

Children between the age of 3-12 months

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anke Langenfeld, PhD	Balgrist University Hospital	Study Chair

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not yet defined

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided