Chronic Low-back PainNCT04046419
In Turkish Version "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"
An observational study of Chronic Low-back Pain and Health Personnel Attitude, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the Turkish validity and reliability of ''Health Care Providers and Impairment Relationship Scale HC (HC-PAIRS)'' developed by Dr Rainville. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Chronic Low-back Pain, Health Personnel Attitude
- What is being tested?
- Turkish validity and reliability
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2019to 30 Aug 2020
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be carried out by physiotherapists working in the KSBU Evliya Celebi Hospital or accessible via internet.
Who may be able to join
- Graduate with a bachelor's degree in physiotherapy and rehabilitation
- To have worked in patients with chronic low back pain
Who cannot join
- Not having experience in the clinic about low back pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Validity and Reliability of "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"
The aim of this study was to determine the Turkish validity and reliability of ''Health Care Providers and Impairment Relationship Scale HC (HC-PAIRS)'' developed by Dr Rainville.
Read the detailed description
Low back pain is one of the reasons for applying to health institutions. Low back pain, which seriously affects patients' lives and leads to major financial losses, causes serious deficiencies in both developing and developed countries. Health professionals' perception of pain, factors associated with pain and fear avoidance attitudes of patients affect the success of treatment. The aim of this study is to determine the Turkish version, validity and reliability of ''Health Care Providers and Impairment Relationship Scale (HC-PAIRS)''. 165 physiotherapist working with chronic low back pain were included 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 homogeneity of the questions in the scale. For concurrent validity, correlation coefficient will be used to determine the agreement between the previously validated scales and the Turkish version of HC PAIRS.
- Conditions
- Chronic Low-back Pain, Health Personnel Attitude
- Being tested
- Turkish validity and reliability
- Keywords
- validity, reliability, Turkish version, HC-PAIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish validity and reliabilityOther
- Explanation of the Turkish version of the scale.
- Translating the Turkish version of the scale into English to ensure consistency with the original scale.
- First application of scales to participants.
- Second application of the scales to the participants.
- Statistical analysis and scaling
What is being measured
The primary outcome is the main question the study is designed to answer.
The Health Care Providers' Pain and Impairment Relationship Scale
The Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS) is a questionnaire for assessing the attitudes and beliefs of health care providers about functional expectations for CLBP patients.17 It consists of 15 statements rated on a 6-point Likert scale ranging from "totally disagree" to "totally agree."
Measured: 10 minute
Turkish version of Tampa Scale for Kinesiophobia
TSK was used for the assessment of kinesiophobia. The items are rated on a 4-point Likert-type scale (1=definitely disagree, 4=completely agree) and the total score is between 17 and 68 points. Higher total score indicates higher level of kinesiophobia.
Measured: 10 minute
Secondary outcomes (1)
Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT)
This tool was developed to distinguish between biomedical and biopsychosocial orientations toward the treatment of low back pain in physiotherapists. The scale uses a 6-point Likert-type scale (1=definitely disagree, 6=definitely agree). Treatment orientation is measured on the biomedical (factor 1) and biopsychosocial (factor 2) subscales. Subscale scores are calculated by simply adding the scores corresponding to the selected response for each item. The subscale with the highest score indicates the respondent's dominant treatment orientation
Measured: 10 minute.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start30 Sep 2019
- Primary completion15 Feb 2020
- Study completion30 Aug 2020
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
- 165 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
- Cihan C AKSOY, PhD, Study director, Kutahya Health Science Universityİsmail SARACOGLU, PhD, Principal investigator, Kutahya Health Science UniversityLütfiye AKKURT, MSc, Principal investigator, Kutahya Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046419
- Sponsor's protocol ID
- KutahyaMSUt
- Status last verified
- Mar 2021
- First submitted
- 2 Aug 2019
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"
- ClinicalTrials.gov ID
- NCT04046419
- Acronym / sponsor ID
- KutahyaMSUt
- Conditions
- Chronic Low-back Pain, Health Personnel Attitude
- Keywords
- validity, reliability, Turkish version, HC-PAIRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 6 Aug 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 determine the Turkish validity and reliability of ''Health Care Providers and Impairment Relationship Scale HC (HC-PAIRS)'' developed by Dr Rainville.
Detailed description
Low back pain is one of the reasons for applying to health institutions. Low back pain, which seriously affects patients' lives and leads to major financial losses, causes serious deficiencies in both developing and developed countries. Health professionals' perception of pain, factors associated with pain and fear avoidance attitudes of patients affect the success of treatment. The aim of this study is to determine the Turkish version, validity and reliability of ''Health Care Providers and Impairment Relationship Scale (HC-PAIRS)''. 165 physiotherapist working with chronic low back pain were included 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 homogeneity of the questions in the scale. For concurrent validity, correlation coefficient will be used to determine the agreement between the previously validated scales and the Turkish version of HC PAIRS.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be carried out by physiotherapists working in the KSBU Evliya Celebi Hospital or accessible via internet.
Key inclusion criteria (2 listed)
- Graduate with a bachelor's degree in physiotherapy and rehabilitation
- To have worked in patients with chronic low back pain
Key exclusion criteria (1 listed)
- Not having experience in the clinic about low back pain
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 |
|---|---|---|
| Turkish validity and reliability1. Explanation of the Turkish version of the scale. 2. Translating the Turkish version of the scale into English to ensure consistency with the original scale. 3. First application of scales to participants. 4. Second application of the scales to the participants. 5. Statistical analysis and scaling | Other | – |
Primary outcome
The Health Care Providers' Pain and Impairment Relationship Scale
Time frame: 10 minute
The Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS) is a questionnaire for assessing the attitudes and beliefs of health care providers about functional expectations for CLBP patients.17 It consists of 15 statements rated on a 6-point Likert scale ranging from "totally disagree" to "totally agree."
Turkish version of Tampa Scale for Kinesiophobia
Time frame: 10 minute
TSK was used for the assessment of kinesiophobia. The items are rated on a 4-point Likert-type scale (1=definitely disagree, 4=completely agree) and the total score is between 17 and 68 points. Higher total score indicates higher level of kinesiophobia.
1 secondary outcome
Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT)
Time frame: 10 minute.
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 15 Oct 2024.
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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.
Cihan C AKSOY, PhD study director
Kutahya Health Science University
İsmail SARACOGLU, PhD principal investigator
Kutahya Health Science University
Lütfiye AKKURT, MSc principal investigator
Kutahya Health Science 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 and Health Personnel Attitude, 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 2 inclusion and 1 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 15 Oct 2024. 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?
The Health Care Providers' Pain and Impairment Relationship Scale (time frame: 10 minute). The study lists 2 primary outcomes in all. 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 Oct 2024.