Measuring Chronic Pain Impact: Measurement Enhancement for Chronic Pain

• ClinicalTrials.gov Identifier: NCT04426812
• Recruitment Status: Recruiting
• First Posted: June 11, 2020
• Last Update Posted: March 10, 2022
• Sponsor: RAND
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); University of California, Los Angeles
• Information provided by (Responsible Party): RAND

Study Description

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.

Condition or disease	Intervention/treatment
Chronic Pain	Other: No intervention; just data collection

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

• Study Type: Observational
• Estimated Enrollment: 3000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Measuring Chronic Pain Impact
• Actual Study Start Date: August 30, 2021
• Estimated Primary Completion Date: February 2023
• Estimated Study Completion Date: February 2023

Groups and Cohorts

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.	Other: No intervention; just data collection; 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; No intervention; just data collection

Outcome Measures

Primary Outcome Measures :

1. Oswestry Disability Index (ODI) [ Time Frame: Baseline only ]
   Measure of function for those with chronic back pain; range 0-100; higher is worse
2. Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: Baseline only ]
   Measure of function for those with chronic back pain; range 0-100; higher is worse
3. 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

Secondary Outcome Measures :

1. PROMIS pain intensity [ Time Frame: Baseline only ]
   Measure of pain intensity; range 0-10; higher is worse
2. PROMIS pain interference [ Time Frame: Baseline only ]
   Measure of the amount of interference pain causes in life; range 4-20; higher is worse
3. PROMIS physical function [ Time Frame: Baseline only ]
   Measure of the impact of a condition on physical function; range 4-20; higher is worse
4. Change in Impact Stratification Score (ISS) [ Time Frame: Baseline and 3 months ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

Criteria

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

Contacts and Locations

Contacts

Contact: Patricia M Herman, ND, PhD; 310-393-0411 ext 7129; pherman@rand.org

Contact: Ron D Hays, PhD; 310.794.2294; drhays@ucla.edu

Locations

United States, California

Online recruitment only - nationwide; Recruiting

Santa Monica, California, United States, 90407

Contact: Patricia Herman, PhD 310-393-0411 ext 7129

Sponsors and Collaborators

RAND

National Center for Complementary and Integrative Health (NCCIH)

University of California, Los Angeles

Investigators

• Principal Investigator: Patricia M Herman, ND, PhD; RAND

More Information

Publications of Results:

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.

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. 2021 Aug 21. pii: usab339. doi: 10.1093/milmed/usab339. [Epub ahead of print]

PROMIS® Health Organization (PHO) 2021 Conference Abstracts. J Patient Rep Outcomes. 2021 Oct 1;5(Suppl 1):90. doi: 10.1186/s41687-021-00349-3.

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 I, Pohlman KA, Walter J, Goertz CM. Health-related quality of life among United States service members with low back pain receiving usual care plus chiropractic care plus usual care vs usual care alone: Secondary outcomes of a pragmatic clinical trial. Pain Med. 2022 Jan 21. pii: pnac009. doi: 10.1093/pm/pnac009. [Epub ahead of print] Erratum in: Pain Med. 2022 May 30;23(6):1198.

Other 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.

• Responsible Party: RAND
• ClinicalTrials.gov Identifier: NCT04426812
• Other Study ID Numbers: RHINO ID 2019-0651; 1R01AT010402-01A1 ( U.S. NIH Grant/Contract )
• First Posted: June 11, 2020
• Last Update Posted: March 10, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: We have 3 types of data in this study. The first is using data from existing datasets gathered in other studies. We don't know whether we will be able to get permission to share those data. The second source is the MTurk sample. We hope to share those data and those of the third source KnowledgePanel. However, in each case we are limited by the regulations of those data collection platforms.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations