Chronic Low Back Pain (CLBP)NCT07916597
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
A study testing Patient Education and ChatGPT in people with Chronic Low Back Pain (CLBP), run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to learn if ChatGPT-generated answers can improve pain beliefs, catastrophizing, and self-efficacy in women with chronic low back pain compared to supervised pain education. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Patient Education and ChatGPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be between 30 and 60 years old
- To have pain lasting longer than 3 months
- To have pain intensity greater than 4 out of 10
- Ability to communicate effectively and understand the study procedures
- Ability to conduct video calls via Microsoft Teams and complete questionnaires via Google Forms.
- To be volunteer to participate in the study
Who cannot join
- Having previously received pain neuroscience/education or having asked questions regarding pain to ChatGPT or any other chatbots
- Being pregnant
- Diagnosis of endocrinological, psychiatric, urogenital, neurological, dermatological, cardiorespiratory, or musculoskeletal diseases, and/or sleep disorders that could interfere with the study outcomes
- Currently undergoing other treatments for low back pain (e.g., physical therapy, acupuncture).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Amasya University
Amasya, Amasya, 05100
Kübra Okuyucu, 0(358)2115005 ext. 4879, aybikesenel@hotmail.com
About this study
The goal of this study is to learn if ChatGPT-generated answers can improve pain beliefs, catastrophizing, and self-efficacy in women with chronic low back pain compared to supervised pain education. The main questions it aims to answer are: Does ChatGPT improve pain beliefs, catastrophizing, and self-efficacy in women with chronic low back pain? Is ChatGPT as effective as supervised pain education? Participants will: complete baseline questionnaires online, attend a single 30-60 minute online session (randomly assigned to either a supervised pain education presentation or asking frequently questions about low back pain to ChatGPT)
Read the detailed description
This study aims to investigate the effects of responses provided by ChatGPT to frequently asked questions about low back pain on pain beliefs, catastrophizing, and self-efficacy in women with chronic low back pain, and to compare them with supervised patient education.
Designed as a randomized controlled trial, this research will be conducted with female participants aged 18-65 with a history of low back pain lasting longer than 3 months will be included. Eligible volunteers will be randomly allocated to either the supervised education group or the ChatGPT group. A single 30-minute session will be conducted with participants in both groups. Participants' pain beliefs will be evaluated using the Pain Beliefs Questionnaire, catastrophizing levels using the Pain Catastrophizing Scale, and self-efficacy levels using the Pain Self-Efficacy Questionnaire. Assessments will be administered twice: immediately before and immediately after the session.
Within the scope of this study, the impact of information obtained from ChatGPT-one of today's widely used and easily accessible AI chatbots-on chronic low back pain, will be revealed. Additionally, comparing these effects with those of supervised pain education may provide a significant contribution to health literacy regarding low back pain.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Patient Education, ChatGPT
- Keywords
- patient education, chronic low back pain, artificial intelligence, ChatGPT, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationOther
Responses to frequently asked questions about low back pain will be developed within the framework of Pain Neuroscience Education, based on Butler and Moseley's (2003) book "Explain Pain" and current low back pain management guidelines. The prepared responses will be compiled into a PowerPoint presentation and delivered by one of the researchers via screen sharing on Microsoft Teams. The presentation is planned to last approximately 30-60 minutes. All participants in this group will attend the presentation conducted by the same researcher. Participants will not be allowed to ask any additional questions during the session.
ChatGPTOther
Frequently asked questions about low back pain found in the literature will be sent to participants via email. During screen sharing on Microsoft Teams, participants will be asked to submit these questions one by one to an AI chatbot and carefully read the responses. The same researcher will accompany the participants while they ask all the questions to the AI tool. This process is planned to take approximately 30-60 minutes. Participants will not be allowed to ask any additional questions during the session. However, once all evaluations are completed, a PDF version of the presentation prepared by the researchers will also be shared with participants in this group.
| Study group | Role | What they receive |
|---|---|---|
| Patient Education Group | Active comparator | Not described Receives: Other: Patient Education |
| ChatGPT Group | Active comparator | Not described Receives: Other: ChatGPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Beliefs Questionnaire
Participants' pain beliefs will be evaluated using the Pain Beliefs Questionnaire. The scale uses a 6-point Likert-type rating ranging from 0 to 5 (never, rarely, sometimes, often, almost always, and always) and consists of 12 items. Two subscale scores are obtained from the questionnaire: psychological pain belief and organic pain belief. A higher score indicates a higher pain belief related to that subscale, whereas a lower score indicates a lower pain belief. The validity and reliability study of the scale has been conducted.
Measured: baseline
Pain Catastrophizing Scale
Participants' level of pain catastrophizing will be evaluated using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item Likert-type self-report scale. Each item is rated on a 0-4 scale. The total score ranges from 0 to 52. It comprises three subscales: rumination, magnification, and helplessness. Higher scores indicate higher levels of catastrophizing. The validity and reliability study of the scale has been conducted.
Measured: baseline
Pain Self-Efficacy Questionnaire
Participants' level of pain-related self-efficacy will be evaluated using the Pain Self-Efficacy Questionnaire (PSEQ). Based on Bandura's concept of self-efficacy, the questionnaire is a 10-item self-report tool designed to measure the degree of confidence in performing a range of activities despite pain. Among questionnaires evaluating pain self-efficacy, it is a practical tool due to its brevity, possesses well-proven validity and reliability, and measures multiple domains of self-efficacy related to social and physical functioning. Each item is rated on a 7-point Likert-type scale (0: Not at all confident, 6: Completely confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functionality despite pain. The validity and reliability study of the questionnaire has been conducted.
Measured: baseline
Pain Beliefs Questionnaire
Participants' pain beliefs will be evaluated using the Pain Beliefs Questionnaire. The scale uses a 6-point Likert-type rating ranging from 0 to 5 (never, rarely, sometimes, often, almost always, and always) and consists of 12 items. Two subscale scores are obtained from the questionnaire: psychological pain belief and organic pain belief. A higher score indicates a higher pain belief related to that subscale, whereas a lower score indicates a lower pain belief. The validity and reliability study of the scale has been conducted.
Measured: immediately after intervention
Pain Catastrophizing Scale
Participants' level of pain catastrophizing will be evaluated using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item Likert-type self-report scale. Each item is rated on a 0-4 scale. The total score ranges from 0 to 52. It comprises three subscales: rumination, magnification, and helplessness. Higher scores indicate higher levels of catastrophizing. The validity and reliability study of the scale has been conducted.
Measured: immediately after intervention
Pain Self-Efficacy Questionnaire
Participants' level of pain-related self-efficacy will be evaluated using the Pain Self-Efficacy Questionnaire (PSEQ). Based on Bandura's concept of self-efficacy, the questionnaire is a 10-item self-report tool designed to measure the degree of confidence in performing a range of activities despite pain. Among questionnaires evaluating pain self-efficacy, it is a practical tool due to its brevity, possesses well-proven validity and reliability, and measures multiple domains of self-efficacy related to social and physical functioning. Each item is rated on a 7-point Likert-type scale (0: Not at all confident, 6: Completely confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functionality despite pain. The validity and reliability study of the questionnaire has been conducted.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybike Senel, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916597
- Sponsor's protocol ID
- 20092026-AS
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
- ClinicalTrials.gov ID
- NCT07916597
- Acronym / sponsor ID
- 20092026-AS
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- patient education, chronic low back pain, artificial intelligence, ChatGPT, pain management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 4 Nov 2026 (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 goal of this study is to learn if ChatGPT-generated answers can improve pain beliefs, catastrophizing, and self-efficacy in women with chronic low back pain compared to supervised pain education. The main questions it aims to answer are: Does ChatGPT improve pain beliefs, catastrophizing, and self-efficacy in women with chronic low back pain? Is ChatGPT as effective as supervised pain education? Participants will: complete baseline questionnaires online, attend a single 30-60 minute online session (randomly assigned to either a supervised pain education presentation or asking frequently questions about low back pain to ChatGPT)
Detailed description
This study aims to investigate the effects of responses provided by ChatGPT to frequently asked questions about low back pain on pain beliefs, catastrophizing, and self-efficacy in women with chronic low back pain, and to compare them with supervised patient education.
Designed as a randomized controlled trial, this research will be conducted with female participants aged 18-65 with a history of low back pain lasting longer than 3 months will be included. Eligible volunteers will be randomly allocated to either the supervised education group or the ChatGPT group. A single 30-minute session will be conducted with participants in both groups. Participants' pain beliefs will be evaluated using the Pain Beliefs Questionnaire, catastrophizing levels using the Pain Catastrophizing Scale, and self-efficacy levels using the Pain Self-Efficacy Questionnaire. Assessments will be administered twice: immediately before and immediately after the session.
Within the scope of this study, the impact of information obtained from ChatGPT-one of today's widely used and easily accessible AI chatbots-on chronic low back pain, will be revealed. Additionally, comparing these effects with those of supervised pain education may provide a significant contribution to health literacy regarding low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Education Group | Active comparator | Other: Patient Education |
| ChatGPT Group | Active comparator | Other: ChatGPT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To be between 30 and 60 years old
- To have pain lasting longer than 3 months
- To have pain intensity greater than 4 out of 10
- Ability to communicate effectively and understand the study procedures
- Ability to conduct video calls via Microsoft Teams and complete questionnaires via Google Forms.
Key exclusion criteria (4 listed)
- Having previously received pain neuroscience/education or having asked questions regarding pain to ChatGPT or any other chatbots
- Being pregnant
- Diagnosis of endocrinological, psychiatric, urogenital, neurological, dermatological, cardiorespiratory, or musculoskeletal diseases, and/or sleep disorders that could interfere with the study outcomes
- Currently undergoing other treatments for low back pain (e.g., physical therapy, acupuncture).
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 |
|---|---|---|
| Patient EducationResponses to frequently asked questions about low back pain will be developed within the framework of Pain Neuroscience Education, based on Butler and Moseley's (2003) book "Explain Pain" and current low back pain management guidelines. The prepared responses will be compiled into a PowerPoint presentation and delivered by one of the researchers via screen sharing on Microsoft Teams. The presentation is planned to last approximately 30-60 minutes. All participants in this group will attend the presentation conducted by the same researcher. Participants will not be allowed to ask any additional questions during the session. | Other | Patient Education Group |
| ChatGPTFrequently asked questions about low back pain found in the literature will be sent to participants via email. During screen sharing on Microsoft Teams, participants will be asked to submit these questions one by one to an AI chatbot and carefully read the responses. The same researcher will accompany the participants while they ask all the questions to the AI tool. This process is planned to take approximately 30-60 minutes. Participants will not be allowed to ask any additional questions during the session. However, once all evaluations are completed, a PDF version of the presentation prepared by the researchers will also be shared with participants in this group. | Other | ChatGPT Group |
Primary outcome
Pain Beliefs Questionnaire
Time frame: baseline
Participants' pain beliefs will be evaluated using the Pain Beliefs Questionnaire. The scale uses a 6-point Likert-type rating ranging from 0 to 5 (never, rarely, sometimes, often, almost always, and always) and consists of 12 items. Two subscale scores are obtained from the questionnaire: psychological pain belief and organic pain belief. A higher score indicates a higher pain belief related to that subscale, whereas a lower score indicates a lower pain belief. The validity and reliability study of the scale has been conducted.
Pain Catastrophizing Scale
Time frame: baseline
Participants' level of pain catastrophizing will be evaluated using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item Likert-type self-report scale. Each item is rated on a 0-4 scale. The total score ranges from 0 to 52. It comprises three subscales: rumination, magnification, and helplessness. Higher scores indicate higher levels of catastrophizing. The validity and reliability study of the scale has been conducted.
Pain Self-Efficacy Questionnaire
Time frame: baseline
Participants' level of pain-related self-efficacy will be evaluated using the Pain Self-Efficacy Questionnaire (PSEQ). Based on Bandura's concept of self-efficacy, the questionnaire is a 10-item self-report tool designed to measure the degree of confidence in performing a range of activities despite pain. Among questionnaires evaluating pain self-efficacy, it is a practical tool due to its brevity, possesses well-proven validity and reliability, and measures multiple domains of self-efficacy related to social and physical functioning. Each item is rated on a 7-point Likert-type scale (0: Not at all confident, 6: Completely confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functionality despite pain. The validity and reliability study of the questionnaire has been conducted.
Pain Beliefs Questionnaire
Time frame: immediately after intervention
Participants' pain beliefs will be evaluated using the Pain Beliefs Questionnaire. The scale uses a 6-point Likert-type rating ranging from 0 to 5 (never, rarely, sometimes, often, almost always, and always) and consists of 12 items. Two subscale scores are obtained from the questionnaire: psychological pain belief and organic pain belief. A higher score indicates a higher pain belief related to that subscale, whereas a lower score indicates a lower pain belief. The validity and reliability study of the scale has been conducted.
Pain Catastrophizing Scale
Time frame: immediately after intervention
Participants' level of pain catastrophizing will be evaluated using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item Likert-type self-report scale. Each item is rated on a 0-4 scale. The total score ranges from 0 to 52. It comprises three subscales: rumination, magnification, and helplessness. Higher scores indicate higher levels of catastrophizing. The validity and reliability study of the scale has been conducted.
Pain Self-Efficacy Questionnaire
Time frame: immediately after intervention
Participants' level of pain-related self-efficacy will be evaluated using the Pain Self-Efficacy Questionnaire (PSEQ). Based on Bandura's concept of self-efficacy, the questionnaire is a 10-item self-report tool designed to measure the degree of confidence in performing a range of activities despite pain. Among questionnaires evaluating pain self-efficacy, it is a practical tool due to its brevity, possesses well-proven validity and reliability, and measures multiple domains of self-efficacy related to social and physical functioning. Each item is rated on a 7-point Likert-type scale (0: Not at all confident, 6: Completely confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functionality despite pain. The validity and reliability study of the questionnaire has been conducted.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education and ChatGPT in people with Chronic Low Back Pain (CLBP), run by Amasya 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aybike Şenel, Assistant Professor (0(358)2115005 ext. 4753, aybikesenel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Beliefs Questionnaire (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?
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 4 Nov 2026.