Validity, Reliability and Responsiveness of Pain Sensitization Questionnaire

February 14, 2022 updated by: Özgül Öztürk, Acibadem University
The aim of this study was to translate the Pain Sensitivity Questionnaire, which was developed to determine the level of pain sensitivity of individuals, to Turkish and to evaluate the validity and reliability of the Turkish version of the scale on knee osteoarthritis patients, and as well as to perform cultural adaptation. Pain sensitivity assessment is used to predict treatment or surgical outcomes of individuals. IPain Sensitivity Questionnaire is a frequently used scale that correlates with experimental pain tests and is used in studies conducted in different patient groups. We believe that adding this scale to our language will contribute to other studies in this field.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

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
      • İ̇stanbul, Turkey, 34752
        • Özgül Öztürk

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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Knee osteoarthritis patients who have chronic pain

Description

Inclusion Criteria:

  • Not having oral or written communication problems in Turkish,
  • Diagnosis of knee osteoarthritis after clinical examination and radiological imaging,
  • Being 40 years or older,
  • To have neurological competence and cognitive level to answer scale questions.

Exclusion Criteria:

  • To have fibromyalgia syndrome or neurological disease that may affect pain sensitivity levels of individuals,
  • To have undergone surgery involving the knee in the last 1 year,
  • The presence of peripheral neuropathy and neuropathy is therefore to be taking medication.

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
Pain Sensitivity Questionnaire
Time Frame: 1-4 week
The Pain Sensitivity Questionnaire was developed to visualize 17 situations that may feel pain in daily life and to indicate possible pain severity. The patient determines the pain severity level from 0 to 10, with 0 indicates no pain, and 10 indicates the most severe pain. The total score of the Pain Sensitivity Questionnaire and the two subscale scores, PSQ-minor and PSQ-moderate, can be calculated. The PSQ-moderate and PSQ-minor subscales consist of 7 items and the total score is calculated on 14 items. The other 3 items were excluded from the scoring of the scale as they normally indicate painless conditions. Total and subscale scores ranged from 0 to 10, and higher scores indicate increased pain sensitivity.
1-4 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Catastrophization Scale
Time Frame: 1-4 week
It consists of a total of 13 items and is scored between 0-52 points. Higher scores mean higher levels of pain catastrophization.
1-4 week
Pressure Pain Threshold
Time Frame: One day
One day

Collaborators and Investigators

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

Sponsor

Acibadem University

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)

January 8, 2020

Primary Completion (Anticipated)

December 28, 2022

Study Completion (Anticipated)

December 28, 2022

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK 2019/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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