NCT02671370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

January 29, 2016

Last Update Submit

May 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cervical Range of Motion (CROM)

    The cervical range of motion will be measured using the CROM device

    Baseline

Secondary Outcomes (3)

  • Neck Disability Index

    Baseline

  • S-ROM-Neck

    Baseline

  • Interviews (personal,semi-structured guided, open-ended questions) in a one-to-one Setting. Recorded with a voice-recorder.

    Baseline

Interventions

There is no intervention. Only measurements and interviews are taken.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with neck pain of any duration

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jaap Swanenburg, PhD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of PT Research

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 2, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

May 9, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

no there is not

Locations