Chronic Low-back PainNCT05201716
Turkish Validity and Reliability of the UW Concerns About Pain Scale
An observational study of Chronic Low-back Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary: The aim of this study was to determine the Turkish validity and reliability of ''UW Concerns About Pain Scale'' developed by Dr. Amtmann. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Jun 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Chronic low back pain
Who may be able to join
- To be between 18-65 years old
- Having a complaint of low back pain for at least 6 months
- Low back pain severity to be 3 points or above according to the Numerical Graded Pain Scale.
Who cannot join
- Using antidepressant-derived drugs
- Having a history of spinal surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43100
About this study
Brief Summary:
The aim of this study was to determine the Turkish validity and reliability of ''UW Concerns About Pain Scale'' developed by Dr. Amtmann.
Read the detailed description
Chronic pain is a common condition, affecting an estimated 20% of people worldwide. The biopsychosocial model of chronic pain is the most current accepted approach to understanding the complexity of pain and disability. One of the most important psychosocial factors in this approach is pain-related self-efficacy, which is defined as the individual's confidence in their ability to tolerate pain and participate in daily activities despite pain. The aim of this study is to determine the Turkish version, validity, and reliability of ''UW Concerns About Pain Scale''. 60 people with chronic low back pain will include in the study. In order to determine the reliability of the scale, the intraclass correlation coefficient (ICC) will be used to determine the level of the relationship between the results of the first and second measurements. Cronbach's alpha coefficient will be used for the homogeneity of the questions in the scale. For construct validity, the correlation coefficient will be used to determine the agreement between the Turkish version of Pain catastrophizing scale and, Turkish version of "Fear Avoidance Beliefs Questionnaire" and The ''UW Concerns About Pain Scale''.
- Conditions
- Chronic Low-back Pain
- Keywords
- Concerns
What is being measured
The primary outcome is the main question the study is designed to answer.
UW Concerns About Pain
The UW Concerns About Pain is intended measure an individual's level of pain catastrophizing. We will use to 8 item form, in study.
Measured: 8 minutes
Secondary outcomes (2)
Turkish version of Pain Catastrophizing Scale (PCS)
PCS was developed by Sullivan et al. in order to identify the catastrophic thoughts or feelings of the patients about the pain and ineffective coping strategies.The scale is a Likert-type self-assessment scale consisting of 13 items.Each item is scored between 0-4 points.The total score ranges from 0 to 52.High scores indicate a high level of catastrophizing.
Measured: 10 minutes
Turkish version of "Fear Avoidance Beliefs Questionnaire"
FABQ was developed Waddell et al. in 1993. FABQ consists of 16 questions and 2 parts. While the first part of the scale evaluates attitudes about physical activities, the second part evaluates attitudes about occupational work. Scoring of the questionnaire is done with a 7-point Likert type scale. The Physical Activity section is scored between 0-24 and the labor section is scored between 0-36. A high score in KKTS indicates an increased level of fear-avoidance attitudes related to low back pain.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Feb 2022
- Primary completion1 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Saracoglu, Kutahya Health Sciences University
- Investigators
- İsmail SARACOGLU, PhD, Study director, Kutahya Health Sciences UniversityCihan Caner AKSOY, PhD, Principal investigator, Kutahya Health Sciences UniversityLütfiye AKKURT, MSc, Principal investigator, Kutahya Health Sciences UniversityHasan Hüseyin GÖKPINAR, MD, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201716
- Sponsor's protocol ID
- KutahyaHSU2
- Status last verified
- Jul 2022
- First submitted
- 9 Jan 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of the UW Concerns About Pain Scale
- ClinicalTrials.gov ID
- NCT05201716
- Acronym / sponsor ID
- KutahyaHSU2
- Conditions
- Chronic Low-back Pain
- Keywords
- Concerns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 21 Jan 2022 (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.
Brief Summary:
The aim of this study was to determine the Turkish validity and reliability of ''UW Concerns About Pain Scale'' developed by Dr. Amtmann.
Detailed description
Chronic pain is a common condition, affecting an estimated 20% of people worldwide. The biopsychosocial model of chronic pain is the most current accepted approach to understanding the complexity of pain and disability. One of the most important psychosocial factors in this approach is pain-related self-efficacy, which is defined as the individual's confidence in their ability to tolerate pain and participate in daily activities despite pain. The aim of this study is to determine the Turkish version, validity, and reliability of ''UW Concerns About Pain Scale''. 60 people with chronic low back pain will include in the study. In order to determine the reliability of the scale, the intraclass correlation coefficient (ICC) will be used to determine the level of the relationship between the results of the first and second measurements. Cronbach's alpha coefficient will be used for the homogeneity of the questions in the scale. For construct validity, the correlation coefficient will be used to determine the agreement between the Turkish version of Pain catastrophizing scale and, Turkish version of "Fear Avoidance Beliefs Questionnaire" and The ''UW Concerns About Pain Scale''.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with Chronic low back pain
Key inclusion criteria (3 listed)
- To be between 18-65 years old
- Having a complaint of low back pain for at least 6 months
- Low back pain severity to be 3 points or above according to the Numerical Graded Pain Scale.
Key exclusion criteria (2 listed)
- Using antidepressant-derived drugs
- Having a history of spinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
UW Concerns About Pain
Time frame: 8 minutes
The UW Concerns About Pain is intended measure an individual's level of pain catastrophizing. We will use to 8 item form, in study.
2 secondary outcomes
Turkish version of Pain Catastrophizing Scale (PCS)
Time frame: 10 minutes
Turkish version of "Fear Avoidance Beliefs Questionnaire"
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
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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.
İsmail SARACOGLU, PhD study director
Kutahya Health Sciences University
Cihan Caner AKSOY, PhD principal investigator
Kutahya Health Sciences University
Lütfiye AKKURT, MSc principal investigator
Kutahya Health Sciences University
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 Chronic Low-back Pain, run by Kutahya Health Sciences 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 8 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
UW Concerns About Pain (time frame: 8 minutes). 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 8 Jul 2022.