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| ID | Type | Description | Link |
|---|---|---|---|
| 5P20NR016605 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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This pilot project will provide an understanding of the contextual variables responsible for chronic low back pain. These variables include, genetic variation, pain sensitivity, reactivity, pain catastrophizing, perceived stress and kinesiphobia. The purpose is to understand the initial efficacy of self-management (SM) strategies on each of these contextual variables, in an effort to inform a personalized approach to managing chronic low back pain and its effect on improved health outcomes.
Chronic low back pain (cLBP) is the second most frequent chronic pain condition in the United States and results in billions of dollars each year in health care expenses, disability and lost productivity. A major factor that contributes to the refractory nature of cLBP is enhanced pain sensitivity, which is an altered state of pain processing that amplifies pain sensation and impairs descending pain inhibition. Enhanced pain sensitivity in patients who develop cLBP is associated with altered expression of pro-nociceptive and inflammatory genes. On the other hand, regular physical activity of at least moderate intensity for 150 or more minutes per week is recommended to reduce pain severity and improve function in individuals with cLBP. Therefore, a deeper mechanistic understanding of the effect of physical activity on the neurophysiologic and gene transcription alterations that characterize cLBP may inform more specific treatment options to optimize pain reduction and reduce the risk of pain chronicity.
The purpose of this longitudinal cohort pilot study is to examine the feasibility, acceptability, and preliminary efficacy of the Problem-solving Pain to Enhance Living Well (PROPEL) self-management (SM) intervention on cLBP. This pre-post intervention study will recruit 40 community dwelling adults (age 18 - 60 years old) with cLBP. They will receive electronic video modules focused on cLBP SM knowledge and weekly phone consultations to facilitate monitoring and problem-solving. All participants will be assessed for primary outcomes including cLBP SM behaviors, physical activity, pain severity and interferance, and pain sensitivity at baseline and every 2 weeks for 12 weeks. The study will examine differential neurophysiologic and gene expression profiles between participants with cLBP at 12-weeks post-intervention and correlate these outcome measures to total duration of physical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROPEL | Experimental | The Problem-solving Pain to Enhance Living Well (PROPEL) intervention entails each participant watching 10 video modules via REDCap. These modules include: (1) pain neurophysiology, (2) catastrophizing, (3) stress reactivity, (4) fear of movement, (5) progressive relaxation, (6) deep breathing, (7) guided imagery, (8) heat, ice and stretching, (9) strategies for physical activity self-activation and (10) problem-solving. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem-solving Pain to Enhance Living Well (PROPEL) | Behavioral | PROPEL incorporates evidence-based, standard of care methods to promote physical activity among individuals with pain, and tools to improve knowledge, skills and confidence to cope with cLBP. The focus is self-management of cLBP. All eligible participants will then undergo baseline data collection, which entails completion of study questionnaires, quantitative sensory testing (QST) and venipuncture for collection of a blood specimen. Participants will be provided with the information to access the PROPEL intervention. All participants will be asked to complete questionnaires at 2, 4, 6, 8, and 10 weeks following baseline testing. At 12 weeks, participants will be scheduled for a final data collection visit, which will follow the same procedures as the baseline visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity | Fitbit for activity tracker | Baseline, 2, 4, 6, 8, 10 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gene expression profiles | RNA sequencing | Baseline and 12 weeks post-intervention |
| Change in pain sensitivity | Quantitative sensory testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wanli Xu, PhD | University of Connecticut | Principal Investigator |
| Angela Starkweather, PhD | University of Connecticut | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut | Storrs | Connecticut | 06269 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37355622 | Derived | Xu W, Zhang Y, Wang Z, Dorsey SG, Starkweather A, Kim K. Pain self-management plus activity tracking and nurse-led support in adults with chronic low back pain: feasibility and acceptability of the problem-solving pain to enhance living well (PROPEL) intervention. BMC Nurs. 2023 Jun 25;22(1):217. doi: 10.1186/s12912-023-01365-y. |
| Label | URL |
|---|---|
| Center for Accelerating Precision Pain Self-Management (CAPPS-M) Website | View source |
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All of the individual participant data that are part of National Institute of Nursing Research (NINR) designated common data elements collected during the trial, after de-identification have been submitted to NIH repository at the Common Data Repository for Nursing Science (cdRNS). Data can be accessed by directly submitting requests at that website.
When will data be available (start and end dates)? Immediately. No end date.
With whom? Anyone who wishes to access the data and creates an account on cdRNS.nih.gov.
By what mechanism will data be made available? Data are available at cdRNS.nih.gov
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Within 2 years
Requests will be submitted through the cdRNS website
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 24, 2025 | |
| Reset | Apr 10, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 24, 2025 | Apr 10, 2025 |
| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Baseline and 12 weeks post-intervention |
| Relationship between pain self-management and pain severity | Change over time through questionnaires | Baseline, 2, 4, 6, 8, 10 and 12 weeks |
| Relationship between pain self-management and pain interferance | Change over time through questionnaires | Baseline, 2, 4, 6, 8, 10 and 12 weeks |
| Relationship between pain self-management and quality of life | Change over time through questionnaires | Baseline, 2, 4, 6, 8, 10 and 12 weeks |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |