Cervical Range of Motion in Neck Pain Patients: A Mixed M... | NCT02671370

Studies
Cervical Range of Motion in Neck Pain Patients: A Mixed Methods Study

NCT02671370

Sponsor

Balgrist University Hospital

Status

Completed

Last Update Posted

May 9, 2017Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Neck Pain

Interventions

Measurement of the range of motion of the cervical spine

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

May 2017

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

Jan 2016

Primary Completion Date

Apr 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Jan 29, 2016

First Submission Date that Met QC Criteria

Feb 1, 2016

First Posted Date

Feb 2, 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

May 8, 2017

Last Update Posted Date

May 9, 2017Actual

Name	Class
Maastricht University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study there are any associations between objective and subjective outcome measures, measuring the cervical range of motion and if the restriction matter to the patient.

Detailed Description

Objective and subjective outcome measures are frequently used assessments in clinical practice.

The investigators will use different subjective and objective outcome measures to evaluate any possible associations, as well as to investigate if restrictions of movement matters to patients.

Additionally to the assessments tools the investigators will use interviews to extend the scope.

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

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measurement of the range of motion of the cervical spine	Other	There is no intervention. Only measurements and interviews are taken.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cervical Range of Motion (CROM)	The cervical range of motion will be measured using the CROM device	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Neck Disability Index	Questionnaire, measuring the subjective restriction of the participant during activities of daily living	Baseline
S-ROM-Neck	Questionnaire, the participants will be asked to assess their ability to move there neck and if they feel restricted.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with any duration of neck pain
Men and women older than 18 years
Signed informed consent

Exclusion Criteria:

Disc herniation of the cervical spine
Spinal canal stenosis
Acute accidents
Surgery of the cervical spine
Pacemaker and / or defibrillator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants with neck pain of any duration

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaap Swanenburg, PhD	Balgrist University Hospital	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

no there is not

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019547	Neck Pain

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided