Validity of the Turkish Version of the Profile Fitness Mapping Neck Questionnaire for Patients With Neck Pain

May 23, 2019 updated by: HATİCE ÇETİN

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The translation of the original version of "Profile Fitness Mapping Neck Questionnaire" to Turkish will be translated by two independent professional translators. Afterwards, a person without a medical history and a native English speaker will be translated into English again. Once the translation stages are complete, the translators will be brought together to discuss the two versions of the questionnaire. Then the final state will be translated into the main language of the questionnaire and the compliance will be checked.

First of all, people who have been suffering from low back pain for at least six months will complete the "Profile Fitness Mapping NeckQuestionnaire", "Neck Disability Index", "SF-36 health related quality of life questionnaire" and "Visual Analog Scale".

Seven days after the questionnaire, the "Profile Fitness Mapping Neck Questionnaire" will be completed again.

Study Type

Observational

Enrollment (Actual)

235

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with neck pain

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Having neurological problems
  • Having vestibular or cerebellar problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile Fitness Mapping Neck Questionnaire
Time Frame: Change from Baseline Profile Fitness Mapping Neck Questionnaire score (functional limitation and symptom score) at 1 week.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index
Time Frame: All of the participants will assess at baseline with this index.
This questionnaire evaluates disability related with neck pain.
All of the participants will assess at baseline with this index.
SF-36 health related quality of life questionnaire
Time Frame: All of the participants will assess at baseline with this questionnaire.
This questionnaire evaluates quality of life.
All of the participants will assess at baseline with this questionnaire.
Visual Analog Scale
Time Frame: All of the participants will assess at baseline with this scale.
This scale evaluates severity of pain.
All of the participants will assess at baseline with this scale.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HATİCE ÇETİN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2018

Primary Completion (Actual)

December 20, 2018

Study Completion (Actual)

January 15, 2019

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 23, 2018

First Posted (Actual)

January 30, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 776348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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