NCT04162730

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 8, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

November 12, 2019

Last Update Submit

February 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pain Catastrophization Scale

    1-4 week

  • Pressure Pain Threshold

    One day

Interventions

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

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Knee osteoarthritis patients who have chronic pain

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özgül Öztürk

Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Somatoform DisordersChronic PainOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

Mental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 14, 2019

Study Start

January 8, 2020

Primary Completion

December 28, 2022

Study Completion

December 28, 2022

Last Updated

February 15, 2022

Record last verified: 2022-02

Locations