Measuring Chronic Pain Impact: Measurement Enhancement for Chronic Pain

NCT04426812 | Completed

• 1 other identifier: RHINO ID 2019-0651
• Study Type: observational
• Target: 11,146
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Oswestry Disability Index (ODI)

  Measure of function for those with chronic back pain; range 0-100; higher is worse

  Baseline only

• Roland-Morris Disability Questionnaire (RMDQ)

  Measure of function for those with chronic back pain; range 0-100; higher is worse

  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

  Baseline only

Secondary Outcomes (4)

• PROMIS pain intensity

  Baseline only

• PROMIS pain interference

  Baseline only

• PROMIS physical function

  Baseline only

• Change in Impact Stratification Score (ISS)

  Baseline and 3 months

Study Arms (2)

MTurk sample

Data collected from a sample of participants in an online convenience platform called MTurk who self-identify as having chronic pain.

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.

Other: No intervention; just data collection

Interventions

No intervention; just data collection OTHER

No intervention; just data collection

KnowledgePanel; MTurk sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• adult
• self-described chronic pain
• member of one of the panels (MTurk or KnowledgePanel) we are using for data collection

You may not qualify if:

• unwillingness to participate

Sponsors & Collaborators

• RAND: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Online recruitment only - nationwide

Santa Monica, California, 90407, United States

Location

Related Publications (14)

• 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.

  PMID: 33684368 RESULT

• 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.

  PMID: 33038933 RESULT

• 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.

  PMID: 34417805 RESULT

• 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.

  PMID: 34595566 RESULT

• 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.

  PMID: 34022052 RESULT

• 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.

  PMID: 35060609 RESULT

• 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.

  PMID: 35728997 RESULT

• 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.

  PMID: 35753878 RESULT

• 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.

  PMID: 36122256 RESULT

• 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.

  PMID: 35768043 RESULT

• 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.

  PMID: 36030893 RESULT

• 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.

  PMID: 36333833 RESULT

• 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.

  PMID: 36151555 RESULT

• 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.

  PMID: 36283654 RESULT

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia M Herman, ND, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 11, 2020
• Study Start: August 30, 2021
• Primary Completion: October 2, 2022
• Study Completion: November 25, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data were made available 3/8/24
• Access Criteria: All researchers with access to ICPSR - openicpsr-198049

Locations

US (1)