Chronic PainNCT04426812
Measuring Chronic Pain Impact: Measurement Enhancement for Chronic Pain
An observational study of Chronic Pain, run by RAND at 1 site in United States.
Trial summary
Many complementary and integrative health approaches have been shown to be effective for chronic pain and included in guidelines. This evidence of effectiveness is built on hundreds of studies representing millions of research dollars, and the ability to analyze and better compare results across these studies is… 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
- How many people
- 11,146 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 25 Nov 2024
- 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: We have two cohorts. Both will have similar inclusion and exclusion criteria. The first from MTurk is a non-probability sample, and the second is from KnowledgePanel and is a probability-based sample, but one that has been established by the group who owns this panel.
Who may be able to join
- adult
- self-described chronic pain
- member of one of the panels (MTurk or KnowledgePanel) we are using for data collection
Who cannot join
- unwillingness to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Online recruitment only - nationwide
Santa Monica, California, 90407
About this study
Official title: Measuring Chronic Pain Impact
Many complementary and integrative health approaches have been shown to be effective for chronic pain and included in guidelines. This evidence of effectiveness is built on hundreds of studies representing millions of research dollars, and the ability to analyze and better compare results across these studies is essential to obtain the full value of this investment. However, useful across-study comparisons which would allow better understanding and targeting of these interventions are hampered by at least two challenges: the lack of common outcome measures and the inability to meaningfully stratify or classify patients.
The first two Aims of this study each address one of these two challenges. The last Aim takes advantage of this study to further test the viability of MTurk as a data collection platform.
Read more
Specific Aim 1 addresses the lack of common outcome measures. This Aim is to develop and evaluate links or crosswalks between the PROMIS-29 and other common (legacy) measures used for chronic pain so that the results of studies using different measures can be compared. Our hypothesis here is that we will be able to create some sort of linkage between PROMIS and legacy measures that will allow for each pair estimates of one to be made from the other.
Specific Aim 2 addresses the inability to meaningfully stratify or subclassify chronic pain patients. This Aim is to evaluate and refine the chronic pain impact stratification scheme (ISS) proposes by the NIH Research Task Force on chronic low back pain, which is based on 9 PROMIS-29 items. Our hypothesis here is that the ISS can be refined so that it can identify subgroups of chronic pain patients with different levels of morbidity and different needs for treatment.
Specific Aim 3 addresses the potential for more efficient data collection using the MTurk platform. This Aim is to evaluate MTurk as a cost- and time-efficient method to collect quality data on individuals with chronic pain. Our hypothesis here is that we find that MTurk produces data of sufficient quality to be of use to future research projects.
Read the detailed description
While there is an extensive literature on the effectiveness of pharmaceutical and nonpharmacologic interventions for chronic low back pain (CLBP), it is challenging to synthesize the findings because of differences in the CLBP samples and in the outcome measures used. The NIH Research Task Force (RTF) on CLBP noted that these differences make it "difficult to compare epidemiologic data and studies of similar or competing interventions, replicate findings, pool data from multiple studies, resolve conflicting conclusions, develop multidisciplinary consensus, or even achieve consensus within a discipline regarding interpretation of findings." To this list we would add that these differences also prevent the use of the results to answer questions such as 'Which therapies work best? And for whom?' This project tackles two things that are needed to address these differences and allow for better cross-study comparisons: we will develop empirical links between different outcome measures to allow their expression in similar units (Aim 1), and we will refine the RTF's proposed stratification (subgrouping) of patients by the impact of their CLBP (Aim 2).
To address the first challenge, in Aim 1 this study will develop and evaluate crosswalks or links between components of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS®) short form (PROMIS-29) and common legacy measures used for chronic pain. The purpose of these crosswalks or links is to allow researchers who measured outcomes using one instrument to estimate what the outcome would be if it had been measured using the other instrument. In particular, we will create crosswalks/links for the two most commonly used instruments used to measure outcomes for CLBP: the Roland-Morris Disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). In addition, depending on data availability and input from our Advisory Council we will create at least two other crosswalks/links between the PROMIS-29 and other legacy measures for CLBP (e.g., the Back Pain Functional Scale) or legacy measures for other types of chronic pain (e.g., the Neck Disability Index for chronic neck pain).
To address the second challenge, in Aim 2 we will evaluate and refine the chronic pain impact stratification scheme proposed by the NIH Research Task Force on chronic low back pain. The proposed scheme uses the Impact Stratification Score (ISS) which is calculated using 9 items from the PROMIS-29. This ISS was intended to identify and categorize patients with chronic pain into groups based on the severity of their condition so that treatment can be better targeted. We will first evaluate the ISS and its properties to determine whether they are stable across different samples and determine whether they can be improved. After we have finalized the components and calculation of the ISS, we will examine its effect on the impacts of chronic pain (e.g., health-related quality of life, healthcare utilization, worker productivity) to identify meaningful cut-points to use to stratify chronic pain patients into subgroups who exhibit different levels of chronic pain impact.
Three types of data will be used in the analyses to address Aims 1 and 2: data from existing datasets built during other studies, data collected from an anonymous national convenience sample using Amazon's Mechanical Turk (MTurk) crowdsourcing platform, and data from members of the probability-based nationally representative KnowledgePanel. Aim 3 will evaluate whether MTurk is a reliable, efficient method to collect data on individuals with chronic pain. One part of this evaluation will involve comparison of the results from MTurk to what was found using KnowledgePanel.
- Conditions
- Chronic Pain
- Being tested
- No intervention; just data collection
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; just data collectionOther
No intervention; just data collection
| Study group | Role | What they receive |
|---|---|---|
| MTurk sample | Data collected from a sample of participants in an online convenience platform called MTurk who self-identify as having chronic pain. Receives: Other: No intervention; just data collection | |
| KnowledgePanel | Data collected from a sample of panel members in an online representative panel called KnowledgePanel who self-identify as having chronic pain. Receives: Other: No intervention; just data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Measure of function for those with chronic back pain; range 0-100; higher is worse
Measured: Baseline only
Roland-Morris Disability Questionnaire (RMDQ)
Measure of function for those with chronic back pain; range 0-100; higher is worse
Measured: Baseline only
Impact Stratification Score (ISS)
Measure of the level of impact chronic pain has on individual's lives; range 8-50; higher is worse
Measured: Baseline only
Secondary outcomes (4)
PROMIS pain intensity
Measure of pain intensity; range 0-10; higher is worse
Measured: Baseline only
PROMIS pain interference
Measure of the amount of interference pain causes in life; range 4-20; higher is worse
Measured: Baseline only
PROMIS physical function
Measure of the impact of a condition on physical function; range 4-20; higher is worse
Measured: Baseline only
Change in Impact Stratification Score (ISS)
Measure of the change in the level of impact chronic pain has on individual's lives; range -42 to +42; positive values are a worsening of impact
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start30 Aug 2021
- Primary completion2 Oct 2022
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Patricia M Herman, ND, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426812
- Sponsor's protocol ID
- RHINO ID 2019-0651
- Status last verified
- Nov 2024
- First submitted
- 5 Jun 2020
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected is shared.
Publications
Edelen MO, Rodriguez A, Herman P, Hays RD. Crosswalking the Patient-Reported Outcomes Measurement Information System Physical Function, Pain Interference, and Pain Intensity Scores to the Roland-Morris Disability Questionnaire and the Oswestry Disability Index. Arch Phys Med Rehabil. 2021 Jul;102(7):1317-1323. doi: 10.1016/j.apmr.2021.02.014. Epub 2021 Mar 5.
PubMed 33684368Herman PM, Edelen MO, Rodriguez A, Hilton LG, Hays RD. A protocol for chronic pain outcome measurement enhancement by linking PROMIS-29 scale to legacy measures and improving chronic pain stratification. BMC Musculoskelet Disord. 2020 Oct 10;21(1):671. doi: 10.1186/s12891-020-03696-2.
PubMed 33038933Dunbar MS, Rodriguez A, Edelen MO, Hays RD, Coulter ID, Siconolfi D, Herman PM. Longitudinal Associations of PROMIS-29 Anxiety and Depression Symptoms With Low Back Pain Impact in a Sample of U.S. Military Service Members. Mil Med. 2023 Mar 20;188(3-4):e630-e636. doi: 10.1093/milmed/usab339.
PubMed 34417805PROMIS(R) Health Organization (PHO) 2021 Conference Abstracts. J Patient Rep Outcomes. 2021 Oct 1;5(Suppl 1):90. doi: 10.1186/s41687-021-00349-3. No abstract available.
PubMed 34595566Hays RD, Orlando Edelen M, Rodriguez A, Herman P. Support for the Reliability and Validity of the National Institutes of Health Impact Stratification Score in a Sample of Active-Duty U.S. Military Personnel with Low Back Pain. Pain Med. 2021 Oct 8;22(10):2185-2190. doi: 10.1093/pm/pnab175.
PubMed 34022052Hays RD, Shannon ZK, Long CR, Spritzer KL, Vining RD, Coulter ID, Pohlman KA, Walter JA, Goertz CM. Health-Related Quality of Life Among United States Service Members with Low Back Pain Receiving Usual Care Plus Chiropractic Care vs Usual Care Alone: Secondary Outcomes of a Pragmatic Clinical Trial. Pain Med. 2022 Aug 31;23(9):1550-1559. doi: 10.1093/pm/pnac009.
PubMed 35060609Hilton LG, Coulter ID, Ryan GW, Hays RD. Comparing the Recruitment of Research Participants With Chronic Low Back Pain Using Amazon Mechanical Turk With the Recruitment of Patients From Chiropractic Clinics: A Quasi-Experimental Study. J Manipulative Physiol Ther. 2021 Oct;44(8):601-611. doi: 10.1016/j.jmpt.2022.02.004. Epub 2022 Jun 18.
PubMed 35728997Hays RD, Slaughter ME, Spritzer KL, Herman PM. Assessing the Significance of Individual Change in 2 Samples of Patients in Treatment for Low Back Pain Using 5 Different Statistical Indicators. J Manipulative Physiol Ther. 2021 Nov-Dec;44(9):699-706. doi: 10.1016/j.jmpt.2022.03.002. Epub 2022 Jun 23.
PubMed 35753878Herman PM, Coulter ID, Hays RD, Rodriguez A, Edelen MO. A Scoping Review of Chronic Low Back Pain Classification Schemes Based on Patient-Reported Outcomes. Pain Physician. 2022 Sep;25(6):471-482.
PubMed 36122256Hays RD, Slaughter M, Rodriguez A, Edelen MO, Herman PM. Analyses of Cross-Sectional Data to Link the PEG With the Patient Reported Outcomes Measurement and Information System (PROMIS) Global Physical Health Scale. J Pain. 2022 Nov;23(11):1904-1911. doi: 10.1016/j.jpain.2022.06.006. Epub 2022 Jun 26.
PubMed 35768043Hays RD, Qureshi N, Edelen M, Rodriguez A, Slaughter M, Herman PM. Crosswalking the National Institutes of Health Impact Stratification Score to the PEG. Arch Phys Med Rehabil. 2023 Mar;104(3):425-429. doi: 10.1016/j.apmr.2022.08.006. Epub 2022 Aug 27.
PubMed 36030893Qureshi N, Edelen M, Hilton L, Rodriguez A, Hays RD, Herman PM. Comparing Data Collected on Amazon's Mechanical Turk to National Surveys. Am J Health Behav. 2022 Oct 17;46(5):497-502. doi: 10.5993/AJHB.46.5.1.
PubMed 36333833Rodriguez A, Edelen MO, Herman PM, Hays RD. Unpacking the impact of chronic pain as measured by the impact stratification score. BMC Musculoskelet Disord. 2022 Sep 23;23(1):884. doi: 10.1186/s12891-022-05834-4.
PubMed 36151555Herman PM, Qureshi N, Arick SD, Edelen MO, Hays RD, Rodriguez A, Weir RL, Coulter ID. Definitions of Chronic Low Back Pain From a Scoping Review, and Analyses of Narratives and Self-Reported Health of Adults With Low Back Pain. J Pain. 2023 Mar;24(3):403-412. doi: 10.1016/j.jpain.2022.10.012. Epub 2022 Oct 23.
PubMed 36283654
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Chronic Pain Impact
- ClinicalTrials.gov ID
- NCT04426812
- Acronym / sponsor ID
- RHINO ID 2019-0651
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,146 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of California, Los Angeles
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 2 Oct 2022 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 11 Jun 2020 (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.
Many complementary and integrative health approaches have been shown to be effective for chronic pain and included in guidelines. This evidence of effectiveness is built on hundreds of studies representing millions of research dollars, and the ability to analyze and better compare results across these studies is essential to obtain the full value of this investment. However, useful across-study comparisons which would allow better understanding and targeting of these interventions are hampered by at least two challenges: the lack of common outcome measures and the inability to meaningfully stratify or classify patients.
The first two Aims of this study each address one of these two challenges. The last Aim takes advantage of this study to further test the viability of MTurk as a data collection platform.
Specific Aim 1 addresses the lack of common outcome measures. This Aim is to develop and evaluate links or crosswalks between the PROMIS-29 and other common (legacy) measures used for chronic pain so that the results of studies using different measures can be compared. Our hypothesis here is that we will be able to create some sort of linkage between PROMIS and legacy measures that will allow for each pair estimates of one to be made from the other.
Specific Aim 2 addresses the inability to meaningfully stratify or subclassify chronic pain patients. This Aim is to evaluate and refine the chronic pain impact stratification scheme (ISS) proposes by the NIH Research Task Force on chronic low back pain, which is based on 9 PROMIS-29 items. Our hypothesis here is that the ISS can be refined so that it can identify subgroups of chronic pain patients with different levels of morbidity and different needs for treatment.
Specific Aim 3 addresses the potential for more efficient data collection using the MTurk platform. This Aim is to evaluate MTurk as a cost- and time-efficient method to collect quality data on individuals with chronic pain. Our hypothesis here is that we find that MTurk produces data of sufficient quality to be of use to future research projects.
Detailed description
While there is an extensive literature on the effectiveness of pharmaceutical and nonpharmacologic interventions for chronic low back pain (CLBP), it is challenging to synthesize the findings because of differences in the CLBP samples and in the outcome measures used. The NIH Research Task Force (RTF) on CLBP noted that these differences make it "difficult to compare epidemiologic data and studies of similar or competing interventions, replicate findings, pool data from multiple studies, resolve conflicting conclusions, develop multidisciplinary consensus, or even achieve consensus within a discipline regarding interpretation of findings." To this list we would add that these differences also prevent the use of the results to answer questions such as 'Which therapies work best? And for whom?' This project tackles two things that are needed to address these differences and allow for better cross-study comparisons: we will develop empirical links between different outcome measures to allow their expression in similar units (Aim 1), and we will refine the RTF's proposed stratification (subgrouping) of patients by the impact of their CLBP (Aim 2).
To address the first challenge, in Aim 1 this study will develop and evaluate crosswalks or links between components of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS®) short form (PROMIS-29) and common legacy measures used for chronic pain. The purpose of these crosswalks or links is to allow researchers who measured outcomes using one instrument to estimate what the outcome would be if it had been measured using the other instrument. In particular, we will create crosswalks/links for the two most commonly used instruments used to measure outcomes for CLBP: the Roland-Morris Disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). In addition, depending on data availability and input from our Advisory Council we will create at least two other crosswalks/links between the PROMIS-29 and other legacy measures for CLBP (e.g., the Back Pain Functional Scale) or legacy measures for other types of chronic pain (e.g., the Neck Disability Index for chronic neck pain).
To address the second challenge, in Aim 2 we will evaluate and refine the chronic pain impact stratification scheme proposed by the NIH Research Task Force on chronic low back pain. The proposed scheme uses the Impact Stratification Score (ISS) which is calculated using 9 items from the PROMIS-29. This ISS was intended to identify and categorize patients with chronic pain into groups based on the severity of their condition so that treatment can be better targeted. We will first evaluate the ISS and its properties to determine whether they are stable across different samples and determine whether they can be improved. After we have finalized the components and calculation of the ISS, we will examine its effect on the impacts of chronic pain (e.g., health-related quality of life, healthcare utilization, worker productivity) to identify meaningful cut-points to use to stratify chronic pain patients into subgroups who exhibit different levels of chronic pain impact.
Three types of data will be used in the analyses to address Aims 1 and 2: data from existing datasets built during other studies, data collected from an anonymous national convenience sample using Amazon's Mechanical Turk (MTurk) crowdsourcing platform, and data from members of the probability-based nationally representative KnowledgePanel. Aim 3 will evaluate whether MTurk is a reliable, efficient method to collect data on individuals with chronic pain. One part of this evaluation will involve comparison of the results from MTurk to what was found using KnowledgePanel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTurk sample | – | Other: No intervention; just data collectionData collected from a sample of participants in an online convenience platform called MTurk who self-identify as having chronic pain. |
| KnowledgePanel | – | Other: No intervention; just data collectionData collected from a sample of panel members in an online representative panel called KnowledgePanel who self-identify as having chronic pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We have two cohorts. Both will have similar inclusion and exclusion criteria. The first from MTurk is a non-probability sample, and the second is from KnowledgePanel and is a probability-based sample, but one that has been established by the group who owns this panel.
Key inclusion criteria (3 listed)
- adult
- self-described chronic pain
- member of one of the panels (MTurk or KnowledgePanel) we are using for data collection
Key exclusion criteria (1 listed)
- unwillingness 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 intervention; just data collectionNo intervention; just data collection | Other | KnowledgePanel, MTurk sample |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: Baseline only
Measure of function for those with chronic back pain; range 0-100; higher is worse
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: Baseline only
Measure of function for those with chronic back pain; range 0-100; higher is worse
Impact Stratification Score (ISS)
Time frame: Baseline only
Measure of the level of impact chronic pain has on individual's lives; range 8-50; higher is worse
4 secondary outcomes
PROMIS pain intensity
Time frame: Baseline only
PROMIS pain interference
Time frame: Baseline only
PROMIS physical function
Time frame: Baseline only
Change in Impact Stratification Score (ISS)
Time frame: Baseline and 3 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 27 Nov 2024.
- Results publication: PubMed 33684368Edelen MO, Rodriguez A, Herman P, Hays RD. Crosswalking the Patient-Reported Outcomes Measurement Information System Physical Function, Pain Interference, and Pain Intensity Scores to the Roland-Morris Disability Questionnaire and the Oswestry Disability Index. Arch Phys Med Rehabil. 2021 Jul;102(7):1317-1323. doi: 10.1016/j.apmr.2021.02.014. Epub 2021 Mar 5.
- Results publication: PubMed 33038933Herman PM, Edelen MO, Rodriguez A, Hilton LG, Hays RD. A protocol for chronic pain outcome measurement enhancement by linking PROMIS-29 scale to legacy measures and improving chronic pain stratification. BMC Musculoskelet Disord. 2020 Oct 10;21(1):671. doi: 10.1186/s12891-020-03696-2.
- Results publication: PubMed 34417805Dunbar MS, Rodriguez A, Edelen MO, Hays RD, Coulter ID, Siconolfi D, Herman PM. Longitudinal Associations of PROMIS-29 Anxiety and Depression Symptoms With Low Back Pain Impact in a Sample of U.S. Military Service Members. Mil Med. 2023 Mar 20;188(3-4):e630-e636. doi: 10.1093/milmed/usab339.
- Results publication: PubMed 34595566PROMIS(R) Health Organization (PHO) 2021 Conference Abstracts. J Patient Rep Outcomes. 2021 Oct 1;5(Suppl 1):90. doi: 10.1186/s41687-021-00349-3. No abstract available.
- Results publication: PubMed 34022052Hays RD, Orlando Edelen M, Rodriguez A, Herman P. Support for the Reliability and Validity of the National Institutes of Health Impact Stratification Score in a Sample of Active-Duty U.S. Military Personnel with Low Back Pain. Pain Med. 2021 Oct 8;22(10):2185-2190. doi: 10.1093/pm/pnab175.
- Results publication: PubMed 35060609Hays RD, Shannon ZK, Long CR, Spritzer KL, Vining RD, Coulter ID, Pohlman KA, Walter JA, Goertz CM. Health-Related Quality of Life Among United States Service Members with Low Back Pain Receiving Usual Care Plus Chiropractic Care vs Usual Care Alone: Secondary Outcomes of a Pragmatic Clinical Trial. Pain Med. 2022 Aug 31;23(9):1550-1559. doi: 10.1093/pm/pnac009.
- Results publication: PubMed 35728997Hilton LG, Coulter ID, Ryan GW, Hays RD. Comparing the Recruitment of Research Participants With Chronic Low Back Pain Using Amazon Mechanical Turk With the Recruitment of Patients From Chiropractic Clinics: A Quasi-Experimental Study. J Manipulative Physiol Ther. 2021 Oct;44(8):601-611. doi: 10.1016/j.jmpt.2022.02.004. Epub 2022 Jun 18.
- Results publication: PubMed 35753878Hays RD, Slaughter ME, Spritzer KL, Herman PM. Assessing the Significance of Individual Change in 2 Samples of Patients in Treatment for Low Back Pain Using 5 Different Statistical Indicators. J Manipulative Physiol Ther. 2021 Nov-Dec;44(9):699-706. doi: 10.1016/j.jmpt.2022.03.002. Epub 2022 Jun 23.
- Results publication: PubMed 36122256Herman PM, Coulter ID, Hays RD, Rodriguez A, Edelen MO. A Scoping Review of Chronic Low Back Pain Classification Schemes Based on Patient-Reported Outcomes. Pain Physician. 2022 Sep;25(6):471-482.
- Results publication: PubMed 35768043Hays RD, Slaughter M, Rodriguez A, Edelen MO, Herman PM. Analyses of Cross-Sectional Data to Link the PEG With the Patient Reported Outcomes Measurement and Information System (PROMIS) Global Physical Health Scale. J Pain. 2022 Nov;23(11):1904-1911. doi: 10.1016/j.jpain.2022.06.006. Epub 2022 Jun 26.
- Results publication: PubMed 36030893Hays RD, Qureshi N, Edelen M, Rodriguez A, Slaughter M, Herman PM. Crosswalking the National Institutes of Health Impact Stratification Score to the PEG. Arch Phys Med Rehabil. 2023 Mar;104(3):425-429. doi: 10.1016/j.apmr.2022.08.006. Epub 2022 Aug 27.
- Results publication: PubMed 36333833Qureshi N, Edelen M, Hilton L, Rodriguez A, Hays RD, Herman PM. Comparing Data Collected on Amazon's Mechanical Turk to National Surveys. Am J Health Behav. 2022 Oct 17;46(5):497-502. doi: 10.5993/AJHB.46.5.1.
- Individual participant dataSharing planned: Yes. All data collected is shared.
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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.
Patricia M Herman, ND, PhD principal investigator
RAND
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, run by RAND 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 3 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 27 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 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?
Oswestry Disability Index (ODI) (time frame: Baseline only). The study lists 3 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 NCT04426812, which also lists 14 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 27 Nov 2024.