Chronic PainNCT03945877
Mixed Methods Study Protocol_Chronic Pain and Marginalized Populations
An observational study of Chronic Pain and Marginalization, Social, run by High Point University at 1 site in United States.
Trial summary
A mixed-methods sequential explanatory design study. The first quantitative phase will be a multi-language survey that includes questions related to pain status, patient beliefs, pain interference/social support, and perspective on healthcare utilization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Marginalization, Social
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 31 Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: English-speaking adults who answer the phone and consent to participate. Spanish and Arabic-speaking adults who consent to participate in an in-person survey.
Who may be able to join
- English, Spanish, and Arabic-speaking adults living in the Piedmont Triad, NC
Who cannot join
- declined to participate
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
High Point University
High Point, North Carolina, 27282
Alicia Emerson, 336-841-9726, aemerson1@highpoint.edu
About this study
Official title: Chronic Musculoskeletal Pain Experiences in Marginalized Populations: A Mixed Methods Study Protocol for Understanding the Impact of Geopolitical, Historical, and Societal Influences
A mixed-methods sequential explanatory design study. The first quantitative phase will be a multi-language survey that includes questions related to pain status, patient beliefs, pain interference/social support, and perspective on healthcare utilization. Latent class analysis (LCA) will be used to generate experience-based subgroups in CMP. The second qualitative phase will use focus group will elucidate, confirm, and more richly describe the findings from the first phase.
Read the detailed description
Background: The global epidemic of chronic musculoskeletal pain (CMP) is an intractable issue adversely impacting gross domestic products and costing billions in lost productivity. The expansion of CMP occurs concurrently with historical global mass population movements. Geopolitical negative and racist rhetoric have arisen in response to increased immigration rates. CMP is an invisible disease decoupled from normal tissue healing and results from the complex interplay of biological and psychological processing. Different theoretical models of CMP development now include potential demographic and socio-cultural factors. CMP occurs disproportionately in populations at risk for marginalization, including women, non-Caucasians, immigrants, and people experiencing increased socioeconomic deprivation. The same marginalized populations also are at greater risk for limited access to healthcare and demonstrate worse functional limitations, outcomes, and quality of life. Aims: The primary aims are 1) to characterize self-reported features in people who have CMP and experience marginalization and 2) to interpret the pain experience for marginalised populations of people who have CMP. Methods: A mixed-methods sequential explanatory design study will be used. The first quantitative phase will be a multi-language survey that includes questions related to pain status, patient beliefs, pain interference/social support, and perspective on healthcare utilization. Latent class analysis (LCA) will be used to generate experience-based subgroups in CMP. Focus group will elucidate, confirm, and more richly describe the findings from the first phase. Discussion: Results from this study will be used to inform clinical conversations with patients who have CMP and experience marginalization. By increasing awareness of the potential influences on the clinical conversation, we hope to build opportunities to address inequities in CMP management.
- Conditions
- Chronic Pain, Marginalization, Social
- Being tested
- No interventions
- Medical subject headings
- Chronic Pain, Social Marginalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| English-speaking Community Members | Survey respondents Receives: Other: No interventions | |
| Spanish-speaking Community Members | Survey respondents Receives: Other: No interventions | |
| Arabic-speaking Community Members | Survey respondents Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative: Community surveys
Demographic data; Survey data
Measured: February 2017-September 2017
Qualitative: Focus groups
Semi-structured interview data obtained from focus groups
Measured: November 2018-December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Feb 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Other
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- High Point University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Otago
- Responsible party
- Principal investigator, Alicia Emerson, High Point University
- Investigators
- Alicia Emerson, PT, DPT, MS, Principal investigator, High Point University and University of Otago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945877
- Sponsor's protocol ID
- HighPointU
- Status last verified
- Jul 2020
- First submitted
- 9 May 2019
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mansfield KE, Sim J, Jordan JL, Jordan KP. A systematic review and meta-analysis of the prevalence of chronic widespread pain in the general population. Pain. 2016 Jan;157(1):55-64. doi: 10.1097/j.pain.0000000000000314.
PubMed 26270591Macfarlane GJ, Barnish MS, Jones GT. Persons with chronic widespread pain experience excess mortality: longitudinal results from UK Biobank and meta-analysis. Ann Rheum Dis. 2017 Nov;76(11):1815-1822. doi: 10.1136/annrheumdis-2017-211476. Epub 2017 Jul 21.
PubMed 28733474Fillingim RB, King CD, Ribeiro-Dasilva MC, Rahim-Williams B, Riley JL 3rd. Sex, gender, and pain: a review of recent clinical and experimental findings. J Pain. 2009 May;10(5):447-85. doi: 10.1016/j.jpain.2008.12.001.
PubMed 19411059Pedraza FI, Nichols VC, LeBron AMW. Cautious Citizenship: The Deterring Effect of Immigration Issue Salience on Health Care Use and Bureaucratic Interactions among Latino US Citizens. J Health Polit Policy Law. 2017 Oct;42(5):925-960. doi: 10.1215/03616878-3940486. Epub 2017 Jun 29.
PubMed 28663179Edwards RR, Moric M, Husfeldt B, Buvanendran A, Ivankovich O. Ethnic similarities and differences in the chronic pain experience: a comparison of african american, Hispanic, and white patients. Pain Med. 2005 Jan-Feb;6(1):88-98. doi: 10.1111/j.1526-4637.2005.05007.x.
PubMed 15669954Kim HJ, Yang GS, Greenspan JD, Downton KD, Griffith KA, Renn CL, Johantgen M, Dorsey SG. Racial and ethnic differences in experimental pain sensitivity: systematic review and meta-analysis. Pain. 2017 Feb;158(2):194-211. doi: 10.1097/j.pain.0000000000000731.
PubMed 27682208Green CR, Anderson KO, Baker TA, Campbell LC, Decker S, Fillingim RB, Kalauokalani DA, Lasch KE, Myers C, Tait RC, Todd KH, Vallerand AH. The unequal burden of pain: confronting racial and ethnic disparities in pain. Pain Med. 2003 Sep;4(3):277-94. doi: 10.1046/j.1526-4637.2003.03034.x.
PubMed 12974827Trost Z, Van Ryckeghem D, Scott W, Guck A, Vervoort T. The Effect of Perceived Injustice on Appraisals of Physical Activity: An Examination of the Mediating Role of Attention Bias to Pain in a Chronic Low Back Pain Sample. J Pain. 2016 Nov;17(11):1207-1216. doi: 10.1016/j.jpain.2016.08.001. Epub 2016 Aug 20.
PubMed 27555428Craig KD. Social communication model of pain. Pain. 2015 Jul;156(7):1198-1199. doi: 10.1097/j.pain.0000000000000185. No abstract available.
PubMed 26086113Harding G, Parsons S, Rahman A, Underwood M. "It struck me that they didn't understand pain": the specialist pain clinic experience of patients with chronic musculoskeletal pain. Arthritis Rheum. 2005 Oct 15;53(5):691-6. doi: 10.1002/art.21451.
PubMed 16208656Franklin ZC, Smith NC, Fowler NE. A qualitative investigation of factors that matter to individuals in the pain management process. Disabil Rehabil. 2016 Sep;38(19):1934-42. doi: 10.3109/09638288.2015.1107782. Epub 2016 Jan 4.
PubMed 26728636Burgess DJ, van Ryn M, Crowley-Matoka M, Malat J. Understanding the provider contribution to race/ethnicity disparities in pain treatment: insights from dual process models of stereotyping. Pain Med. 2006 Mar-Apr;7(2):119-34. doi: 10.1111/j.1526-4637.2006.00105.x.
PubMed 16634725Klonoff EA. Disparities in the provision of medical care: an outcome in search of an explanation. J Behav Med. 2009 Feb;32(1):48-63. doi: 10.1007/s10865-008-9192-1. Epub 2009 Jan 6.
PubMed 19127421
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Musculoskeletal Pain Experiences in Marginalized Populations: A Mixed Methods Study Protocol for Understanding the Impact of Geopolitical, Historical, and Societal Influences
- ClinicalTrials.gov ID
- NCT03945877
- Acronym / sponsor ID
- HighPointU
- Conditions
- Chronic Pain, Marginalization, Social
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- High Point UniversityUniversity, hospital or other
- Collaborators
- University of Otago
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 10 May 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.
A mixed-methods sequential explanatory design study. The first quantitative phase will be a multi-language survey that includes questions related to pain status, patient beliefs, pain interference/social support, and perspective on healthcare utilization. Latent class analysis (LCA) will be used to generate experience-based subgroups in CMP. The second qualitative phase will use focus group will elucidate, confirm, and more richly describe the findings from the first phase.
Detailed description
Background: The global epidemic of chronic musculoskeletal pain (CMP) is an intractable issue adversely impacting gross domestic products and costing billions in lost productivity. The expansion of CMP occurs concurrently with historical global mass population movements. Geopolitical negative and racist rhetoric have arisen in response to increased immigration rates. CMP is an invisible disease decoupled from normal tissue healing and results from the complex interplay of biological and psychological processing. Different theoretical models of CMP development now include potential demographic and socio-cultural factors. CMP occurs disproportionately in populations at risk for marginalization, including women, non-Caucasians, immigrants, and people experiencing increased socioeconomic deprivation. The same marginalized populations also are at greater risk for limited access to healthcare and demonstrate worse functional limitations, outcomes, and quality of life. Aims: The primary aims are 1) to characterize self-reported features in people who have CMP and experience marginalization and 2) to interpret the pain experience for marginalised populations of people who have CMP. Methods: A mixed-methods sequential explanatory design study will be used. The first quantitative phase will be a multi-language survey that includes questions related to pain status, patient beliefs, pain interference/social support, and perspective on healthcare utilization. Latent class analysis (LCA) will be used to generate experience-based subgroups in CMP. Focus group will elucidate, confirm, and more richly describe the findings from the first phase. Discussion: Results from this study will be used to inform clinical conversations with patients who have CMP and experience marginalization. By increasing awareness of the potential influences on the clinical conversation, we hope to build opportunities to address inequities in CMP management.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| English-speaking Community Members | – | Other: No interventionsSurvey respondents |
| Spanish-speaking Community Members | – | Other: No interventionsSurvey respondents |
| Arabic-speaking Community Members | – | Other: No interventionsSurvey respondents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- English-speaking adults who answer the phone and consent to participate. Spanish and Arabic-speaking adults who consent to participate in an in-person survey.
Key inclusion criteria (1 listed)
- English, Spanish, and Arabic-speaking adults living in the Piedmont Triad, NC
Key exclusion criteria (1 listed)
- declined to participate
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 |
|---|---|---|
| No interventionsNo interventions | Other | Arabic-speaking Community Members, English-speaking Community Members, Spanish-speaking Community Members |
Primary outcome
Quantitative: Community surveys
Time frame: February 2017-September 2017
Demographic data; Survey data
Qualitative: Focus groups
Time frame: November 2018-December 2019
Semi-structured interview data obtained from focus groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Background: PubMed 26270591Mansfield KE, Sim J, Jordan JL, Jordan KP. A systematic review and meta-analysis of the prevalence of chronic widespread pain in the general population. Pain. 2016 Jan;157(1):55-64. doi: 10.1097/j.pain.0000000000000314.
- Background: PubMed 28733474Macfarlane GJ, Barnish MS, Jones GT. Persons with chronic widespread pain experience excess mortality: longitudinal results from UK Biobank and meta-analysis. Ann Rheum Dis. 2017 Nov;76(11):1815-1822. doi: 10.1136/annrheumdis-2017-211476. Epub 2017 Jul 21.
- Background: PubMed 19411059Fillingim RB, King CD, Ribeiro-Dasilva MC, Rahim-Williams B, Riley JL 3rd. Sex, gender, and pain: a review of recent clinical and experimental findings. J Pain. 2009 May;10(5):447-85. doi: 10.1016/j.jpain.2008.12.001.
- Background: PubMed 28663179Pedraza FI, Nichols VC, LeBron AMW. Cautious Citizenship: The Deterring Effect of Immigration Issue Salience on Health Care Use and Bureaucratic Interactions among Latino US Citizens. J Health Polit Policy Law. 2017 Oct;42(5):925-960. doi: 10.1215/03616878-3940486. Epub 2017 Jun 29.
- Background: PubMed 15669954Edwards RR, Moric M, Husfeldt B, Buvanendran A, Ivankovich O. Ethnic similarities and differences in the chronic pain experience: a comparison of african american, Hispanic, and white patients. Pain Med. 2005 Jan-Feb;6(1):88-98. doi: 10.1111/j.1526-4637.2005.05007.x.
- Background: PubMed 27682208Kim HJ, Yang GS, Greenspan JD, Downton KD, Griffith KA, Renn CL, Johantgen M, Dorsey SG. Racial and ethnic differences in experimental pain sensitivity: systematic review and meta-analysis. Pain. 2017 Feb;158(2):194-211. doi: 10.1097/j.pain.0000000000000731.
- Background: PubMed 12974827Green CR, Anderson KO, Baker TA, Campbell LC, Decker S, Fillingim RB, Kalauokalani DA, Lasch KE, Myers C, Tait RC, Todd KH, Vallerand AH. The unequal burden of pain: confronting racial and ethnic disparities in pain. Pain Med. 2003 Sep;4(3):277-94. doi: 10.1046/j.1526-4637.2003.03034.x.
- Background: PubMed 27555428Trost Z, Van Ryckeghem D, Scott W, Guck A, Vervoort T. The Effect of Perceived Injustice on Appraisals of Physical Activity: An Examination of the Mediating Role of Attention Bias to Pain in a Chronic Low Back Pain Sample. J Pain. 2016 Nov;17(11):1207-1216. doi: 10.1016/j.jpain.2016.08.001. Epub 2016 Aug 20.
- Background: PubMed 26086113Craig KD. Social communication model of pain. Pain. 2015 Jul;156(7):1198-1199. doi: 10.1097/j.pain.0000000000000185. No abstract available.
- Background: PubMed 16208656Harding G, Parsons S, Rahman A, Underwood M. "It struck me that they didn't understand pain": the specialist pain clinic experience of patients with chronic musculoskeletal pain. Arthritis Rheum. 2005 Oct 15;53(5):691-6. doi: 10.1002/art.21451.
- Background: PubMed 26728636Franklin ZC, Smith NC, Fowler NE. A qualitative investigation of factors that matter to individuals in the pain management process. Disabil Rehabil. 2016 Sep;38(19):1934-42. doi: 10.3109/09638288.2015.1107782. Epub 2016 Jan 4.
- Background: PubMed 16634725Burgess DJ, van Ryn M, Crowley-Matoka M, Malat J. Understanding the provider contribution to race/ethnicity disparities in pain treatment: insights from dual process models of stereotyping. Pain Med. 2006 Mar-Apr;7(2):119-34. doi: 10.1111/j.1526-4637.2006.00105.x.
- 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.
Alicia Emerson, PT, DPT, MS principal investigator
High Point University and University of Otago
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 Chronic Pain and Marginalization, Social, run by High Point 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: status not confirmed, as of the sponsor's last update on 30 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alicia Emerson, PT, DPT, MS (336-841-9726, aemerson1@highpoint.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative: Community surveys (time frame: February 2017-September 2017). The study lists 2 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 NCT03945877, which also lists 13 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 30 Jul 2020.