Validity, Reliability and Responsiveness of Pain Sensitization Questionnaire

Knee Osteoarthritis Clinical Trial

Official title:

Validity, Reliability and Responsiveness of Pain Sensitization Questionnaire

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04162730
• Other study ID #: ATADEK 2019/17
• Status: Active, not recruiting
• Start date: January 8, 2020
• Est. completion date: December 28, 2022

Study information

• Verified date: February 2022
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 28, 2022
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Knee Osteoarthritis
• Osteoarthritis, Knee
• Pain Syndrome
• Pain, Chronic

Intervention

Other:
• Pressure pain threshold and behavioural data
Pressure pain threshold level of the knee region will be collected and behavioural data will be measured

Locations

Country	Name	City	State
Turkey	Özgül Öztürk	I?stanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Sensitivity Questionnaire	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	Pain Catastrophization Scale	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
Secondary	Pressure Pain Threshold		One day