NCT03637998

Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain

The Impact of Physical Activity on the Neurophysiologic and Gene Expression Profiles of Chronic Low Back Pain: A Longitudinal Study Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Connecticut · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Low Back Pain
• Self-Management

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-21
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-08-20
• Last updated: 2023-11-28

Locations

1 site across 1 country: United States