Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain
Condition: Chronic Low Back Pain; Self-Management
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): Problem-solving Pain to Enhance Living Well (PROPEL)
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Gene expression; Quantitative Sensory Testing; Genotyping