Pain SyndromeNCT04162730
Validity, Reliability and Responsiveness of Pain Sensitization Questionnaire
An observational study of Pain Syndrome and Pain, Chronic, run by Acibadem University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pain Syndrome, Pain, Chronic, Knee Osteoarthritis
- What is being tested?
- Pressure pain threshold and behavioural data
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2020to 28 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Knee osteoarthritis patients who have chronic pain
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pain Syndrome, Pain, Chronic, Knee Osteoarthritis
- Being tested
- Pressure pain threshold and behavioural data
- Medical subject headings
- Somatoform Disorders, Chronic Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure pain threshold and behavioural dataOther
Pressure pain threshold level of the knee region will be collected and behavioural data will be measured
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-4 week
Secondary outcomes (2)
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.
Measured: 1-4 week
Pressure Pain Threshold
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start8 Jan 2020
- Primary completion28 Dec 2022 (estimated)
- Study completion28 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162730
- Sponsor's protocol ID
- ATADEK 2019/17
- Status last verified
- Feb 2022
- First submitted
- 12 Nov 2019
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity, Reliability and Responsiveness of Pain Sensitization Questionnaire
- ClinicalTrials.gov ID
- NCT04162730
- Acronym / sponsor ID
- ATADEK 2019/17
- Conditions
- Pain Syndrome, Pain, Chronic, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 28 Dec 2022 (estimated)
- Study completion
- 28 Dec 2022 (estimated)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Knee osteoarthritis patients who have chronic pain
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure pain threshold and behavioural dataPressure pain threshold level of the knee region will be collected and behavioural data will be measured | Other | – |
Primary outcome
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.
2 secondary outcomes
Pain Catastrophization Scale
Time frame: 1-4 week
Pressure Pain Threshold
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Syndrome and Pain, Chronic, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Sensitivity Questionnaire (time frame: 1-4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.