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

• Sponsor: HATİCE ÇETİN (Other)
• Overall Status: Completed
• CT.gov ID: NCT03415737
• Collaborator: (none)
• Enrollment: 235
• Location: 1
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 92.9

Study Details

Study Description

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	Phase
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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 235 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Validity of the Turkish Version of the Profile Fitness Mapping Neck Questionnaire for Patients With Neck Pain
• Actual Study Start Date: Oct 30, 2018
• Actual Primary Completion Date: Dec 20, 2018
• Actual Study Completion Date: Jan 15, 2019

Outcome Measures

Primary Outcome Measures

1. Profile Fitness Mapping Neck Questionnaire [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 [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 [All of the participants will assess at baseline with this questionnaire.]

   This questionnaire evaluates quality of life.

3. Visual Analog Scale [All of the participants will assess at baseline with this scale.]

   This scale evaluates severity of pain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University	Ankara		Turkey

Sponsors and Collaborators

• HATİCE ÇETİN

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: HATİCE ÇETİN, MSc, Pt, Hacettepe University
• ClinicalTrials.gov Identifier: NCT03415737
• Other Study ID Numbers: 776348
• First Posted: Jan 30, 2018
• Last Update Posted: May 24, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of May 24, 2019