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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03415737
Recruitment Status : Not yet recruiting
First Posted : January 30, 2018
Last Update Posted : October 15, 2018
Information provided by (Responsible Party):
HATİCE ÇETİN, Hacettepe University

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.

Condition or disease Intervention/treatment
Pain Neck Pain Evaluations, Diagnostic Self Assessment, Self Other: Questionnaire

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 [Patient Registry]
Estimated Enrollment : 235 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Validity of the Turkish Version of the Profile Fitness Mapping Neck Questionnaire for Patients With Neck Pain
Estimated Study Start Date : October 30, 2018
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Questionnaire
    Profile Fitness Mapping Neck Questionnaire

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Neck Disability Index [ Time Frame: All of the participants will assess at baseline with this index. ]
    This questionnaire evaluates disability related with neck pain.

  2. 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.

  3. Visual Analog Scale [ Time Frame: All of the participants will assess at baseline with this scale. ]
    This scale evaluates severity of pain.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with neck pain

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

Responsible Party: HATİCE ÇETİN, MSc, Pt, Hacettepe University Identifier: NCT03415737     History of Changes
Other Study ID Numbers: 776348
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neck Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms