PainNCT03785353
The Effects of Pain Neuroscience Education in a Spanish-Speaking Population
A study testing PNE lecture in people with Pain and Educational Problems, run by Shenandoah University at 1 site in United States.
Trial summary
Pain Neuroscience Education (PNE) has been shown to be effective to alter beliefs and decrease pain among individuals with musculoskeletal pain. Additionally, PNE has been shown to alter beliefs among middle school children. This study plans to assess the effects of PNE within a group of Spanish-speaking individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Educational Problems
- What is being tested?
- PNE lecture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2019to 15 Mar 2021
- 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
- Participants must speak Spanish at least 50% of the time at home OR Spanish must be the first language learned. Participants must also be willing to sit and listen to lecture and fill out quiz before and after.
Who cannot join
- Any individual under the age of 18 will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Pain Neuroscience Education (PNE) has been shown to be effective to alter beliefs and decrease pain among individuals with musculoskeletal pain. Additionally, PNE has been shown to alter beliefs among middle school children. This study plans to assess the effects of PNE within a group of Spanish-speaking individuals.
Read the detailed description
Chronic pain is a topic of discussion that is becoming increasingly prevalent among healthcare professionals. With the ever-growing opioid epidemic, there are a variety of discussions on different modes of treatment other than opioid prescription. Pain neuroscience education, or PNE, is one of these alternative treatment options. PNE focuses on a patient's understanding of pain itself and relates this to the current pain they are experiencing. PNE is often a discussion between provider and patient that utilizes a series of stories, metaphors, and examples where pain is described from a point of view that is not strictly medical. Recent literature suggests there is a lack of knowledge regarding pain in the United States, particularly in the Spanish-speaking population. This population is also less likely to seek a physician's advice for pain management. For these reasons, this study will focus on the Spanish-speaking population within the Winchester community. Due to success within prior PNE studies, this study will be conducted through a classroom lecture. The overarching purpose of this study is to examine the change in knowledge of pain in the Spanish-speaking population immediately following a PNE lecture composed of stories, metaphors, and examples about pain. Because Spanish-speaking individuals are less likely to seek out a medical provider, the study may support an additional treatment option for managing chronic pain. Not only will this provide further research to support the benefits of PNE, but there is the potential to modify a participant's perception of their own pain through this educational lecture.
- Conditions
- Pain, Educational Problems
- Being tested
- PNE lecture
- Keywords
- Pain Neuroscience Education, Spanish-speaking
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNE lectureBehavioural
A translated (from English to Spanish) lecture on Pain Neuroscience Education
| Study group | Role | What they receive |
|---|---|---|
| PNE Group | Experimental | A group of Spanish-speaking individuals will listen to a translated lecture related to PNE (PNE lecture). They will fill out the R-NPQ pre and post the lecture. Receives: Behavioral: PNE lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
R-NPQ
Revised Neuroscience of Pain Questionnaire
Measured: Immediately post-lecture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start26 Mar 2019
- Primary completion27 Mar 2019
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will arrive at a location TBD on the day of data collection. Consent forms will be dispersed to participants, who will be able to ask any questions they may have before signing. A Spanish-speaking researcher will be available to answer those questions. After consent is received, each participant will draw a random number that will be used to link their responses to pre- and post-lecture surveys. After consent is received, a pre-test on pain knowledge and beliefs will be administered. A 30-minute Pain Neuroscience Education (PNE) lecture will be given to participants in Spanish. A post-test on pain knowledge and beliefs will be administered.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenandoah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Hartstein, Shenandoah University
- Investigators
- Sheri A Hale, PT, PhD, ATC, Study director, Shenandoah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785353
- Sponsor's protocol ID
- ShenandoahU(2018-2019)
- Status last verified
- Mar 2021
- First submitted
- 20 Dec 2018
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Louw A, Podalak J, Zimney K, Schmidt S, Puentedura EJ. Can pain beliefs change in middle school students? A study of the effectiveness of pain neuroscience education. Physiother Theory Pract. 2018 Jul;34(7):542-550. doi: 10.1080/09593985.2017.1423142. Epub 2018 Jan 8.
PubMed 29308954Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
PubMed 27351541Louw A, Zimney K, O'Hotto C, Hilton S. The clinical application of teaching people about pain. Physiother Theory Pract. 2016 Jul;32(5):385-95. doi: 10.1080/09593985.2016.1194652. Epub 2016 Jun 28.
PubMed 27351903
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pain Neuroscience Education in a Spanish-Speaking Population
- ClinicalTrials.gov ID
- NCT03785353
- Acronym / sponsor ID
- ShenandoahU(2018-2019)
- Conditions
- Pain, Educational Problems
- Keywords
- Pain Neuroscience Education, Spanish-speaking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shenandoah UniversityUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 24 Dec 2018 (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.
Pain Neuroscience Education (PNE) has been shown to be effective to alter beliefs and decrease pain among individuals with musculoskeletal pain. Additionally, PNE has been shown to alter beliefs among middle school children. This study plans to assess the effects of PNE within a group of Spanish-speaking individuals.
Detailed description
Chronic pain is a topic of discussion that is becoming increasingly prevalent among healthcare professionals. With the ever-growing opioid epidemic, there are a variety of discussions on different modes of treatment other than opioid prescription. Pain neuroscience education, or PNE, is one of these alternative treatment options. PNE focuses on a patient's understanding of pain itself and relates this to the current pain they are experiencing. PNE is often a discussion between provider and patient that utilizes a series of stories, metaphors, and examples where pain is described from a point of view that is not strictly medical. Recent literature suggests there is a lack of knowledge regarding pain in the United States, particularly in the Spanish-speaking population. This population is also less likely to seek a physician's advice for pain management. For these reasons, this study will focus on the Spanish-speaking population within the Winchester community. Due to success within prior PNE studies, this study will be conducted through a classroom lecture. The overarching purpose of this study is to examine the change in knowledge of pain in the Spanish-speaking population immediately following a PNE lecture composed of stories, metaphors, and examples about pain. Because Spanish-speaking individuals are less likely to seek out a medical provider, the study may support an additional treatment option for managing chronic pain. Not only will this provide further research to support the benefits of PNE, but there is the potential to modify a participant's perception of their own pain through this educational lecture.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will arrive at a location TBD on the day of data collection. Consent forms will be dispersed to participants, who will be able to ask any questions they may have before signing. A Spanish-speaking researcher will be available to answer those questions. After consent is received, each participant will draw a random number that will be used to link their responses to pre- and post-lecture surveys. After consent is received, a pre-test on pain knowledge and beliefs will be administered. A 30-minute Pain Neuroscience Education (PNE) lecture will be given to participants in Spanish. A post-test on pain knowledge and beliefs will be administered.
| Arm | Type | Receives |
|---|---|---|
| PNE Group | Experimental | Behavioral: PNE lectureA group of Spanish-speaking individuals will listen to a translated lecture related to PNE (PNE lecture). They will fill out the R-NPQ pre and post the lecture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must speak Spanish at least 50% of the time at home OR Spanish must be the first language learned. Participants must also be willing to sit and listen to lecture and fill out quiz before and after.
Key exclusion criteria (1 listed)
- Any individual under the age of 18 will be excluded from the study.
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 |
|---|---|---|
| PNE lectureA translated (from English to Spanish) lecture on Pain Neuroscience Education | Behavioural | PNE Group |
Primary outcome
R-NPQ
Time frame: Immediately post-lecture
Revised Neuroscience of Pain Questionnaire
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 16 Mar 2021.
- Results publication: PubMed 29308954Louw A, Podalak J, Zimney K, Schmidt S, Puentedura EJ. Can pain beliefs change in middle school students? A study of the effectiveness of pain neuroscience education. Physiother Theory Pract. 2018 Jul;34(7):542-550. doi: 10.1080/09593985.2017.1423142. Epub 2018 Jan 8.
- Results publication: PubMed 27351541Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
- Results publication: PubMed 27351903Louw A, Zimney K, O'Hotto C, Hilton S. The clinical application of teaching people about pain. Physiother Theory Pract. 2016 Jul;32(5):385-95. doi: 10.1080/09593985.2016.1194652. Epub 2016 Jun 28.
- 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.
Sheri A Hale, PT, PhD, ATC study director
Shenandoah 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 PNE lecture in people with Pain and Educational Problems, run by Shenandoah University at 1 site in United States.
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: finished, as of the sponsor's last update on 16 Mar 2021. 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 United States. 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?
R-NPQ (time frame: Immediately post-lecture). 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 NCT03785353, which also lists 3 linked publications.
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 16 Mar 2021.