Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain (PROPEL)
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|ClinicalTrials.gov Identifier: NCT03637998|
Recruitment Status : Suspended (Due to COVID-19)
First Posted : August 20, 2018
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain Self-Management||Behavioral: Problem-solving Pain to Enhance Living Well (PROPEL)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Impact of Physical Activity on the Neurophysiologic and Gene Expression Profiles of Chronic Low Back Pain: A Longitudinal Study Protocol|
|Actual Study Start Date :||September 21, 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2020|
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.
Behavioral: Problem-solving Pain to Enhance Living Well (PROPEL)
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.
- Change in physical activity [ Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 weeks ]Fitbit for activity tracker
- Change in gene expression profiles [ Time Frame: Baseline and 12 weeks post-intervention ]RNA sequencing
- Change in pain sensitivity [ Time Frame: Baseline and 12 weeks post-intervention ]Quantitative sensory testing
- Relationship between pain self-management and pain severity [ Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 weeks ]Change over time through questionnaires
- Relationship between pain self-management and pain interferance [ Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 weeks ]Change over time through questionnaires
- Relationship between pain self-management and quality of life [ Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 weeks ]Change over time through questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637998
|United States, Connecticut|
|University of Connecticut|
|Storrs, Connecticut, United States, 06269|
|Principal Investigator:||Kyounghae Kim, PhD||University of Connecticut|
|Study Director:||Angela Starkweather, PhD||University of Connecticut|