NCT03415737

Brief Summary

As patients improve on one parametric result, the results on the other parametric may worsen, but the total score may not be affected. For this reason, it would be useful to make measurements that evaluate all the parameters of the patients. Thus, it would be more advantageous to score both pain and symptoms separately, as well as activity limitations. Therefore, neck specific surveys are needed to meet this need. For this reason, this study was planned to determine the validity of the questionnaire named "Profile Fitness Mapping Neck Questionnaire" in patients with neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

January 8, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

January 8, 2018

Last Update Submit

May 23, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Profile Fitness Mapping Neck Questionnaire

    This questionnaire measures symptoms and functional limitations about neck pain.

    Change from Baseline Profile Fitness Mapping Neck Questionnaire score (functional limitation and symptom score) at 1 week.

Secondary Outcomes (3)

  • Neck Disability Index

    All of the participants will assess at baseline with this index.

  • SF-36 health related quality of life questionnaire

    All of the participants will assess at baseline with this questionnaire.

  • Visual Analog Scale

    All of the participants will assess at baseline with this scale.

Interventions

Profile Fitness Mapping Neck Questionnaire

Eligibility Criteria

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

Patients with neck pain

You may qualify if:

  • Neck pain for more than six months during activity or rest
  • Having a problem with the neck based on clinical examination and story

You may not qualify if:

  • Having neurological problems
  • Having vestibular or cerebellar problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Bjorklund M, Hamberg J, Heiden M, Barnekow-Bergkvist M. The ProFitMap-neck--reliability and validity of a questionnaire for measuring symptoms and functional limitations in neck pain. Disabil Rehabil. 2012;34(13):1096-107. doi: 10.3109/09638288.2011.635747. Epub 2011 Dec 12.

    PMID: 22149067BACKGROUND

MeSH Terms

Conditions

PainNeck Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc, Pt

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 30, 2018

Study Start

October 30, 2018

Primary Completion

December 20, 2018

Study Completion

January 15, 2019

Last Updated

May 24, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations