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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03415737
Other study ID # 776348
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 30, 2018
Est. completion date January 15, 2019

Study information

Verified date May 2019
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 235
Est. completion date January 15, 2019
Est. primary completion date December 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Questionnaire
Profile Fitness Mapping Neck Questionnaire

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
HATICE ÇETIN

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Björklund 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. — View Citation

Outcome

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