- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04426812
Measuring Chronic Pain Impact: Measurement Enhancement for Chronic Pain
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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California
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Santa Monica, California, United States, 90407
- Online recruitment only - nationwide
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult
- self-described chronic pain
- member of one of the panels (MTurk or KnowledgePanel) we are using for data collection
Exclusion Criteria:
- unwillingness to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
MTurk sample
Data collected from a sample of participants in an online convenience platform called MTurk who self-identify as having chronic pain.
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No intervention; just data collection
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KnowledgePanel
Data collected from a sample of panel members in an online representative panel called KnowledgePanel who self-identify as having chronic pain.
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No intervention; just data collection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry Disability Index (ODI)
Time Frame: Baseline only
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Measure of function for those with chronic back pain; range 0-100; higher is worse
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Baseline only
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Roland-Morris Disability Questionnaire (RMDQ)
Time Frame: Baseline only
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Measure of function for those with chronic back pain; range 0-100; higher is worse
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Baseline only
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Impact Stratification Score (ISS)
Time Frame: Baseline only
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Measure of the level of impact chronic pain has on individual's lives; range 8-50; higher is worse
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Baseline only
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PROMIS pain intensity
Time Frame: Baseline only
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Measure of pain intensity; range 0-10; higher is worse
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Baseline only
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PROMIS pain interference
Time Frame: Baseline only
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Measure of the amount of interference pain causes in life; range 4-20; higher is worse
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Baseline only
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PROMIS physical function
Time Frame: Baseline only
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Measure of the impact of a condition on physical function; range 4-20; higher is worse
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Baseline only
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Change in Impact Stratification Score (ISS)
Time Frame: Baseline and 3 months
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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
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Baseline and 3 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patricia M Herman, ND, PhD, RAND
Publications and helpful links
General Publications
- Herman 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.
- 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.
- PROMIS(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.
- Hays 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.
- Hays 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. Erratum In: Pain Med. 2022 May 30;23(6):1198.
- Dunbar 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.
- Hilton 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.
- Hays 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.
- Herman 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.
- Hays 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.
- Hays 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.
- Qureshi 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.
- Rodriguez 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.
- Herman 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHINO ID 2019-0651
- 1R01AT010402-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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