Low Back PainNCT06109246
The Patient Enablement Instrument for Back Pain Turkish Version, Validity and Reliability Study
An observational study of Low Back Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Most people experience low back pain at some point in their lives, and most low back pain is classified as nonspecific because the factor causing the pain cannot be identified. Current guidelines recommend self-management interventions for the management of nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Oct 2023to 30 Dec 2023
- 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
- Adult, Older adult
Study population: Individuals who have been experiencing low back pain for at least 3 months and agree to participate in the study
Who may be able to join
- Having low back pain for at least 3 months
Who cannot join
- Having acute pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Tokat Province
About this study
Most people experience low back pain at some point in their lives, and most low back pain is classified as nonspecific because the factor causing the pain cannot be identified. Current guidelines recommend self-management interventions for the management of nonspecific low back pain. The most commonly used assessment measures measure pain, disability, and quality of life. However, it is important to evaluate patients' ability to manage their nonspecific LBP-specific disease.
In 1997, Howie and colleagues introduced the concept of enablement, which represents patients' enablement, understanding of, and ability to cope with their health and illness. They developed the "The Patient Enablement Instrument" to measure patient competence based on the theory that if patients' competence increases, other important outcomes will improve. The Patient Enablement Instrument has since been translated into many languages and has generally demonstrated moderate to good validity and reliability. However, there are limitations to using the Patient Enablement Instrument as an outcome measure.
Inspired by the Patient Enablement Instrument, researchers from Denmark and Sweden developed the Patient Enablement Instrument for Back Pain , which could potentially be used as an outcome measure for interventions aimed at improving self-management in people seeking treatment for low back pain. In 2021, Nielsen et al. The validity and reliability of the scale was determined by and its use was recommended in the population experiencing low back pain. The aim of our study is to culturally adapt the Patient Enablement Instrument for Back Pain into Turkish and to examine its validity and reliability.
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Enablement Instrument for Back Pain
Each question is given a score between 0 and 10, allowing changes in the patient to be measured more sensitively. On a 0-10 numerical rating scale, 0 = "to a very low degree" and 10 = "to a very high degree". The maximum total score that can be obtained is 60, and higher scores indicate higher enablement.
Measured: Baseline
Patient Enablement Instrument for Back Pain
Each question is given a score between 0 and 10, allowing changes in the patient to be measured more sensitively. On a 0-10 numerical rating scale, 0 = "to a very low degree" and 10 = "to a very high degree". The maximum total score that can be obtained is 60, and higher scores indicate higher enablement.
Measured: After 1 week (retest)
The Brief Illness Perception Questionnaire
The scale consists of eight items. The eighth item on the scale questions the causal factors of the disease. The other 7 items in the scale have a Likert-type scoring scale from 0 to 10.
Measured: Baseline
Fear-Avoidance Belief Questionnaire
It is a 16-item scale. It consists of 2 parts; The first part evaluates fear-avoidance attitudes related to physical activity, and the second part evaluates fear-avoidance attitudes related to work. Items with a 7-point Likert type receive a minimum of 0 points when the patient chooses the statement 'I completely disagree' and a maximum of 6 points when the patient chooses the statement 'I completely agree'.
Measured: Baseline
Oswestry Low Back Pain Disability Questionnaire
It is a measurement method that evaluates daily life activities and consists of 10 questions. Questions include pain severity, personal care, weight lifting, walking, sitting, standing, sleep status, sexual and social life, and traveling. Each question consists of six items and is scored between 0-5.
Measured: Baseline
Short Form 36
The subscales of the scale are: physical function (10 items), social function (2 items), role limitations due to physical functions (4 items), role limitations due to emotional problems 31 (3 items), mental health (5 items), energy (4 items). item), pain (2 items) and general perception of health (5 items). Subscales evaluate health between 0 and 100, with 0 indicating the lowest quality of life and 100 indicating the highest quality of life.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start26 Oct 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Erol, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109246
- Sponsor's protocol ID
- GaziosmanpasaU_Erol_09
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Erol E, Arikan H. The patient enablement instrument for back pain turkish version, validity and reliability study. J Back Musculoskelet Rehabil. 2025 Sep;38(5):1044-1050. doi: 10.1177/10538127251322855. Epub 2025 Mar 25.
PubMed 40129386
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient Enablement Instrument for Back Pain Turkish Version, Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT06109246
- Acronym / sponsor ID
- GaziosmanpasaU_Erol_09
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 26 Oct 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 31 Oct 2023 (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.
Most people experience low back pain at some point in their lives, and most low back pain is classified as nonspecific because the factor causing the pain cannot be identified. Current guidelines recommend self-management interventions for the management of nonspecific low back pain. The most commonly used assessment measures measure pain, disability, and quality of life. However, it is important to evaluate patients' ability to manage their nonspecific LBP-specific disease.
In 1997, Howie and colleagues introduced the concept of enablement, which represents patients' enablement, understanding of, and ability to cope with their health and illness. They developed the "The Patient Enablement Instrument" to measure patient competence based on the theory that if patients' competence increases, other important outcomes will improve. The Patient Enablement Instrument has since been translated into many languages and has generally demonstrated moderate to good validity and reliability. However, there are limitations to using the Patient Enablement Instrument as an outcome measure.
Inspired by the Patient Enablement Instrument, researchers from Denmark and Sweden developed the Patient Enablement Instrument for Back Pain , which could potentially be used as an outcome measure for interventions aimed at improving self-management in people seeking treatment for low back pain. In 2021, Nielsen et al. The validity and reliability of the scale was determined by and its use was recommended in the population experiencing low back pain. The aim of our study is to culturally adapt the Patient Enablement Instrument for Back Pain into Turkish and to examine its validity and reliability.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals who have been experiencing low back pain for at least 3 months and agree to participate in the study
Key inclusion criteria (1 listed)
- Having low back pain for at least 3 months
Key exclusion criteria (1 listed)
- Having acute pain
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
Patient Enablement Instrument for Back Pain
Time frame: Baseline
Each question is given a score between 0 and 10, allowing changes in the patient to be measured more sensitively. On a 0-10 numerical rating scale, 0 = "to a very low degree" and 10 = "to a very high degree". The maximum total score that can be obtained is 60, and higher scores indicate higher enablement.
Patient Enablement Instrument for Back Pain
Time frame: After 1 week (retest)
Each question is given a score between 0 and 10, allowing changes in the patient to be measured more sensitively. On a 0-10 numerical rating scale, 0 = "to a very low degree" and 10 = "to a very high degree". The maximum total score that can be obtained is 60, and higher scores indicate higher enablement.
The Brief Illness Perception Questionnaire
Time frame: Baseline
The scale consists of eight items. The eighth item on the scale questions the causal factors of the disease. The other 7 items in the scale have a Likert-type scoring scale from 0 to 10.
Fear-Avoidance Belief Questionnaire
Time frame: Baseline
It is a 16-item scale. It consists of 2 parts; The first part evaluates fear-avoidance attitudes related to physical activity, and the second part evaluates fear-avoidance attitudes related to work. Items with a 7-point Likert type receive a minimum of 0 points when the patient chooses the statement 'I completely disagree' and a maximum of 6 points when the patient chooses the statement 'I completely agree'.
Oswestry Low Back Pain Disability Questionnaire
Time frame: Baseline
It is a measurement method that evaluates daily life activities and consists of 10 questions. Questions include pain severity, personal care, weight lifting, walking, sitting, standing, sleep status, sexual and social life, and traveling. Each question consists of six items and is scored between 0-5.
Short Form 36
Time frame: Baseline
The subscales of the scale are: physical function (10 items), social function (2 items), role limitations due to physical functions (4 items), role limitations due to emotional problems 31 (3 items), mental health (5 items), energy (4 items). item), pain (2 items) and general perception of health (5 items). Subscales evaluate health between 0 and 100, with 0 indicating the lowest quality of life and 100 indicating the highest quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 40129386Erol E, Arikan H. The patient enablement instrument for back pain turkish version, validity and reliability study. J Back Musculoskelet Rehabil. 2025 Sep;38(5):1044-1050. doi: 10.1177/10538127251322855. Epub 2025 Mar 25.
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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.
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 Low Back Pain, run by Tokat Gaziosmanpasa 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 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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?
Contact Erkan Erol (+905547920118, erkanerol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Enablement Instrument for Back Pain (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06109246, which also lists 1 linked publication.
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 31 Oct 2023.