Pain, ChronicNCT05359900
The Effect of Pain Education on Chiropractic Students' Understanding of Chronic Pain
A study testing Pain neuroscience education and Red Flag Education in people with Pain, Chronic and Education, run by Teesside University at 4 sites in United Kingdom.
Trial summary
Chronic pain is the leading cause of disability worldwide affecting just under 28 million people in the UK. Chronic pain conditions require a biopsychosocial rather than a biomedical model of care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic, Education
- What is being tested?
- Pain neuroscience education and Red Flag Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 6 Jan 2023to 19 Nov 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current Chiropractic students enrolled at either: Teesside University; The Welsh institute of Chiropractic - University of South Wales; The AECC University College; McTimoney College of Chiropractic; London Southbank University
- Willing to consent to attending two educational sessions followed by completing questionnaires
Who cannot join
- Chiropractic students not actively enrolled at either: Teesside University; The Welsh institute of Chiropractic - University of South Wales; The AECC University College; McTimoney College of Chiropractic; London Southbank University
- Participants will be excluded if they have previously received in depth education on red flags and or pain neurophysiology.
- Students not willing to consent to attending two educational sessions followed by the completion of questionnaires
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
McTimoney College of Chiropractic
Abingdon
The AECC University College
Bournemouth
London Southbank University
London
The Welsh institute of Chiropractic - University of South Wales
Pontypridd
About this study
Official title: The Effect of Pain Education on Chiropractic Students' Understanding of Chronic Pain, Clinical Recommendations and Attitudes Towards People With Chronic Pain
Chronic pain is the leading cause of disability worldwide affecting just under 28 million people in the UK. Chronic pain conditions require a biopsychosocial rather than a biomedical model of care. Biomedical management lacks evidence of effectiveness but also has the potential to exacerbate the condition by raising fears and anxiety about potential pathological abnormalities.
Thus, the pre-registration phase is an important point where an individual's understanding of, and beliefs about, pain and people with pain may be shaped for the future. The need for improved and better education of healthcare professionals to support best practice for low back pain with the aim of integrating professionals' management of low back pain and fostering innovation in practice is well recognised. Pain education research with pre-registration chiropractors is lacking.
Read more
Therefore, this study aims to:
To compare the effect of two pain education intervention, through a multi-site randomised control trial, on the following three questionnaire based outcome measures:
- Knowledge (understanding) of chronic pain
- Attitudes towards chronic pain patients
- Pain management behaviours
Read the detailed description
In 2011 Briggs et al described pain education at undergraduate level for healthcare professionals as 'woefully inadequate'. Pain Neurophysiology Education (PNE) can improve undergraduates' pain understanding/management, however previous RCTs used single discipline groups and immediate follow-up. Investigation of the effectiveness of this education on students across the multi-professional team with medium-to-long-term follow-up will provide important new information on the generalisability of existing data and whether or not any changes in pain understanding/management are maintained over time.
This study aims to contribute to the development of neuromusculoskeletal chiropractic education by identifying whether or not this education, which aims to up skill healthcare professionals of the future, is effective and can change their behaviours in practice to enhance patient care in chronic pain management. PNE has been shown to be useful in patient care in conjunction with other treatment methods. If this intervention is successful in altering pain attitudes and knowledge in keeping with modern science then students may feel more confident and able to manage pain post qualification. The findings of this study will support or refute the addition of PNE into healthcare professional undergraduate programmes
- Conditions
- Pain, Chronic, Education
- Being tested
- Pain neuroscience education, Red Flag Education
- 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 lecture
Red Flag EducationOther
Red Flag education lecture
| Study group | Role | What they receive |
|---|---|---|
| Pain neuroscience education | Experimental | Pain neuroscience education group. One-off, 70 minute duration session delivered by Dr Cormac Ryan. Receives: Other: Pain neuroscience education |
| Red flag education | Active comparator | Red flags education group. One-off 70 minute duration session delivered by Dr Cormac Ryan. Receives: Other: Red Flag Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 12-item Revised Pain Neurophysiology Quiz (change assessed)
This is a validated tool for assessing knowledge of pain physiology. Measures knowledge of pain physiology using a 12 point validated questionnaire. Low score is poor sign. Scores range from 0-12.
Measured: Immediate and 6-month follow-up
The 10-item Red Flags knowledge questionnaire (change assessed)
This is a questionnaire containing 10 yes/no questions to assess participants knowledge of red flags. Low score is a poor sign. Scores range from 0-10.
Measured: Immediate and 6-month follow-up
The 13-item Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS) (change assessed)
this a validated measure of health care professionals attitudes towards the ability of patients with pain to function despite their pain. The Health Care Providers Pain and Impairment Relationship Scale assesses attitudes and beliefs towards pain using a 13 item validated questionnaire. High score is a worse outcome. Scores range from 13-91.
Measured: Immediate and 6-month follow-up
Case vignette (change assessed)
Measures clinical practise behaviours in pain management. A validated proxy measure of clinical behaviour, MCQ weighted as appropriate or inappropriate according to current national clinical guidelines. A low score is considered good, and scores range from 4 to 20.
Measured: Immediate and 6-month follow-up
Secondary outcomes (1)
Semi-structured Interviews
Participants will be invited to take part in a semi-structured interview based in realtion to their knowledge retention and subject understanding.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start6 Jan 2023
- Primary completion30 May 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-site, single-blind two arm, randomised control trial. The study would be conducted an five sites in total: Teesside University; The Welsh institute of Chiropractic - University of South Wales; The AECC University College; McTimoney College of Chiropractic; London Southbank University. Each site will follow the same protocol. Randomisation will occur at each individual site. Data will be pooled for analysis.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- London South Bank University, McTimoney College of Chiropractic, AECC University College, University of South Wales
- Responsible party
- Principal investigator, Paul Chesterton, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359900
- Sponsor's protocol ID
- TeessideUniversity22
- Status last verified
- Nov 2024
- First submitted
- 11 Mar 2022
- Last updated
- 20 Nov 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pain Education on Chiropractic Students' Understanding of Chronic Pain, Clinical Recommendations and Attitudes Towards People With Chronic Pain
- ClinicalTrials.gov ID
- NCT05359900
- Acronym / sponsor ID
- TeessideUniversity22
- Conditions
- Pain, Chronic, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- London South Bank University, McTimoney College of Chiropractic, AECC University College, University of South Wales
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 4 May 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.
Chronic pain is the leading cause of disability worldwide affecting just under 28 million people in the UK. Chronic pain conditions require a biopsychosocial rather than a biomedical model of care. Biomedical management lacks evidence of effectiveness but also has the potential to exacerbate the condition by raising fears and anxiety about potential pathological abnormalities.
Thus, the pre-registration phase is an important point where an individual's understanding of, and beliefs about, pain and people with pain may be shaped for the future. The need for improved and better education of healthcare professionals to support best practice for low back pain with the aim of integrating professionals' management of low back pain and fostering innovation in practice is well recognised. Pain education research with pre-registration chiropractors is lacking.
Therefore, this study aims to:
To compare the effect of two pain education intervention, through a multi-site randomised control trial, on the following three questionnaire based outcome measures:
- Knowledge (understanding) of chronic pain
- Attitudes towards chronic pain patients
- Pain management behaviours
Detailed description
In 2011 Briggs et al described pain education at undergraduate level for healthcare professionals as 'woefully inadequate'. Pain Neurophysiology Education (PNE) can improve undergraduates' pain understanding/management, however previous RCTs used single discipline groups and immediate follow-up. Investigation of the effectiveness of this education on students across the multi-professional team with medium-to-long-term follow-up will provide important new information on the generalisability of existing data and whether or not any changes in pain understanding/management are maintained over time.
This study aims to contribute to the development of neuromusculoskeletal chiropractic education by identifying whether or not this education, which aims to up skill healthcare professionals of the future, is effective and can change their behaviours in practice to enhance patient care in chronic pain management. PNE has been shown to be useful in patient care in conjunction with other treatment methods. If this intervention is successful in altering pain attitudes and knowledge in keeping with modern science then students may feel more confident and able to manage pain post qualification. The findings of this study will support or refute the addition of PNE into healthcare professional undergraduate programmes
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-site, single-blind two arm, randomised control trial. The study would be conducted an five sites in total: Teesside University; The Welsh institute of Chiropractic - University of South Wales; The AECC University College; McTimoney College of Chiropractic; London Southbank University. Each site will follow the same protocol. Randomisation will occur at each individual site. Data will be pooled for analysis.
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience education | Experimental | Other: Pain neuroscience educationPain neuroscience education group. One-off, 70 minute duration session delivered by Dr Cormac Ryan. |
| Red flag education | Active comparator | Other: Red Flag EducationRed flags education group. One-off 70 minute duration session delivered by Dr Cormac Ryan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current Chiropractic students enrolled at either: Teesside University; The Welsh institute of Chiropractic - University of South Wales; The AECC University College; McTimoney College of Chiropractic; London Southbank University
- Willing to consent to attending two educational sessions followed by completing questionnaires
Key exclusion criteria (3 listed)
- Chiropractic students not actively enrolled at either: Teesside University; The Welsh institute of Chiropractic - University of South Wales; The AECC University College; McTimoney College of Chiropractic; London Southbank University
- Participants will be excluded if they have previously received in depth education on red flags and or pain neurophysiology.
- Students not willing to consent to attending two educational sessions followed by the completion of questionnaires
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 lecture | Other | Pain neuroscience education |
| Red Flag EducationRed Flag education lecture | Other | Red flag education |
Primary outcome
The 12-item Revised Pain Neurophysiology Quiz (change assessed)
Time frame: Immediate and 6-month follow-up
This is a validated tool for assessing knowledge of pain physiology. Measures knowledge of pain physiology using a 12 point validated questionnaire. Low score is poor sign. Scores range from 0-12.
The 10-item Red Flags knowledge questionnaire (change assessed)
Time frame: Immediate and 6-month follow-up
This is a questionnaire containing 10 yes/no questions to assess participants knowledge of red flags. Low score is a poor sign. Scores range from 0-10.
The 13-item Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS) (change assessed)
Time frame: Immediate and 6-month follow-up
this a validated measure of health care professionals attitudes towards the ability of patients with pain to function despite their pain. The Health Care Providers Pain and Impairment Relationship Scale assesses attitudes and beliefs towards pain using a 13 item validated questionnaire. High score is a worse outcome. Scores range from 13-91.
Case vignette (change assessed)
Time frame: Immediate and 6-month follow-up
Measures clinical practise behaviours in pain management. A validated proxy measure of clinical behaviour, MCQ weighted as appropriate or inappropriate according to current national clinical guidelines. A low score is considered good, and scores range from 4 to 20.
1 secondary outcome
Semi-structured Interviews
Time frame: 6-month follow-up
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 20 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 and Red Flag Education in people with Pain, Chronic and Education, run by Teesside University at 4 sites in United Kingdom.
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 3 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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 12-item Revised Pain Neurophysiology Quiz (change assessed) (time frame: Immediate and 6-month follow-up). The study lists 4 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 20 Nov 2024.