Chronic PainNCT04007679
Pain Neuroscience Education in Students
A study testing Pain neuroscience education in people with Chronic Pain and Educational Problems, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to evaluate the effect of a 70-minute Pain neuroscience education (PNE) session on physiotherapy students' knowledge of pain and their beliefs and attitudes about the treatment of patients with chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Educational Problems
- What is being tested?
- Pain neuroscience education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2018to 30 May 2019
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- participants who study in physiotherapy.
- willing to participate
Who cannot join
- Individuals in years 4 were excluded.
- participants who received an in-depth session about pain previously.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
KutahyaMSU
Kütahya, Kutahya Health Sciences University, 43000
About this study
Official title: The Effects of Pain Neuroscience Education in Undergraduate Physiotherapy
This study was designed to evaluate the effect of a 70-minute Pain neuroscience education (PNE) session on physiotherapy students' knowledge of pain and their beliefs and attitudes about the treatment of patients with chronic pain.
Read the detailed description
To investigate the effect of a 70 minute pain neuroscience education session on physiotherapy students' knowledge of pain and their beliefs and attitudes about the treatment of patients with chronic pain. This study was a single-center, cross-sectional study on the pain knowledge of students in a four-year physiotherapy program and their beliefs and attitudes about patients with back pain.Students were eligible to participate if they were enrolled at physiotherapy undergraduate program at Kütahya Health Sciences University Faculty of Health Sciences. Individuals were excluded if they had previously received in depth-teaching on pain neuroscience. The study was completed with 156 students from different classes (first, second, and third year of the program) who agreed to participate in the study. All participants were informed about the study and signed informed consent forms. Pain neurophysiology questionnaire and Pain Attitudes and Beliefs Scale for Physiotherapists were used to assess pain knowladge and attitudes and beliefs. After recording their demographic information, the participants completed the Neuroscience of Pain Questionnaire (NPQ) and Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT) at three time points: pre-PNE, immediately post-PNE, and 6 months after PNE.
- Conditions
- Chronic Pain, Educational Problems
- Being tested
- Pain neuroscience education
- Keywords
- pain neuroscience education, chronic pain, physiotherapy students
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience educationOther
Pain neuroscience education (PNE) was conducted in physical conditions similar to the university classrooms where the study was performed. The sessions were conducted as 70-minute didactic group lessons with the same content held in separate sessions for students in each class. PowerPoint (Microsoft Corp., Redmond, WA, USA) presentations prepared by the instructor were used in all sessions. Metaphors, anecdotes, graphics, and pictures were used in an attempt to convey the information and messages about pain physiology and theory more permanently and effectively. In the PNE sessions, it was explained that the nervous system can be overprotective and that in addition to the sensitivity of the central nervous system, nociceptive transmission can be affected by an individual's thoughts, beliefs, and surroundings. At the end of the session, the students were given time to ask questions, but group discussion was limited to 15 minutes due to time restrictions.
| Study group | Role | What they receive |
|---|---|---|
| Pain education group | Experimental | Pain education was conducted in physical conditions similar to the university classrooms where the study was performed for all participants. Receives: Other: Pain neuroscience education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurophysiology of Pain Questionnaire (NPQ)
The NPQ was designed to assess pain knowledge and consists of 19 questions with choices of "true", "false", or "I don't know." The questionnaire was developed in 2003 by Moseley , the validity study was conducted by Catley et al. , and it was determined as effective in the evaluation of pain knowledge. The total score is 0-19, with higher score indicating more correct answers. It was reported that the NPQ can be used both with healthcare professionals and with patients after some modifications to make it more comprehensible for patients.
Measured: Baseline and six months
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. In the biomedical treatment orientation, the predominant belief is that the source of pain and disability is a specific pathology and tissue damage, and therefore the main goal is to treat the signs and symptoms of the pathology [19]. In the biopsychosocial treatment orientation, pain and disability can occur in the absence of tissue injury and are affected by psychological and social factors. 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.
Measured: Baseline and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start20 Sep 2018
- Primary completion30 Mar 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 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 AKSOY, Phd, Study director, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007679
- Sponsor's protocol ID
- KutahyaMSUnpq
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pain Neuroscience Education in Undergraduate Physiotherapy
- ClinicalTrials.gov ID
- NCT04007679
- Acronym / sponsor ID
- KutahyaMSUnpq
- Conditions
- Chronic Pain, Educational Problems
- Keywords
- pain neuroscience education, chronic pain, physiotherapy students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 5 Jul 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.
This study was designed to evaluate the effect of a 70-minute Pain neuroscience education (PNE) session on physiotherapy students' knowledge of pain and their beliefs and attitudes about the treatment of patients with chronic pain.
Detailed description
To investigate the effect of a 70 minute pain neuroscience education session on physiotherapy students' knowledge of pain and their beliefs and attitudes about the treatment of patients with chronic pain. This study was a single-center, cross-sectional study on the pain knowledge of students in a four-year physiotherapy program and their beliefs and attitudes about patients with back pain.Students were eligible to participate if they were enrolled at physiotherapy undergraduate program at Kütahya Health Sciences University Faculty of Health Sciences. Individuals were excluded if they had previously received in depth-teaching on pain neuroscience. The study was completed with 156 students from different classes (first, second, and third year of the program) who agreed to participate in the study. All participants were informed about the study and signed informed consent forms. Pain neurophysiology questionnaire and Pain Attitudes and Beliefs Scale for Physiotherapists were used to assess pain knowladge and attitudes and beliefs. After recording their demographic information, the participants completed the Neuroscience of Pain Questionnaire (NPQ) and Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT) at three time points: pre-PNE, immediately post-PNE, and 6 months after PNE.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain education group | Experimental | Other: Pain neuroscience educationPain education was conducted in physical conditions similar to the university classrooms where the study was performed for all participants. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- participants who study in physiotherapy.
- willing to participate
Key exclusion criteria (2 listed)
- Individuals in years 4 were excluded.
- participants who received an in-depth session about pain previously.
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 |
|---|---|---|
| Pain neuroscience educationPain neuroscience education (PNE) was conducted in physical conditions similar to the university classrooms where the study was performed. The sessions were conducted as 70-minute didactic group lessons with the same content held in separate sessions for students in each class. PowerPoint (Microsoft Corp., Redmond, WA, USA) presentations prepared by the instructor were used in all sessions. Metaphors, anecdotes, graphics, and pictures were used in an attempt to convey the information and messages about pain physiology and theory more permanently and effectively. In the PNE sessions, it was explained that the nervous system can be overprotective and that in addition to the sensitivity of the central nervous system, nociceptive transmission can be affected by an individual's thoughts, beliefs, and surroundings. At the end of the session, the students were given time to ask questions, but group discussion was limited to 15 minutes due to time restrictions. | Other | Pain education group |
Primary outcome
Neurophysiology of Pain Questionnaire (NPQ)
Time frame: Baseline and six months
The NPQ was designed to assess pain knowledge and consists of 19 questions with choices of "true", "false", or "I don't know." The questionnaire was developed in 2003 by Moseley , the validity study was conducted by Catley et al. , and it was determined as effective in the evaluation of pain knowledge. The total score is 0-19, with higher score indicating more correct answers. It was reported that the NPQ can be used both with healthcare professionals and with patients after some modifications to make it more comprehensible for patients.
1 secondary outcome
Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT)
Time frame: Baseline and six months
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.
- 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. This study is not recruiting at the moment.
Cihan AKSOY, Phd study director
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?
A study testing Pain neuroscience education in people with Chronic Pain and Educational Problems, 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 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 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?
Neurophysiology of Pain Questionnaire (NPQ) (time frame: Baseline and six months). 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.