Reducing Sedentary Time in Chronic Low Back Pain: Sedentary Intervention Using Motivational Interviewing and Technology
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study will test the effects of a sedentary behavior intervention on pain processing,
      blood bio-markers and pain symptoms in individuals with chronic low back pain. The behavioral
      intervention will include a wrist-worn activity monitor that will notify participants when
      they have been sedentary for too long, motivational interviewing, and habit development.
    

Detailed description: 
      Chronic low back pain (cLBP) is a prevalent and costly condition that is associated with
      substantial individual and societal burden. Exercise is a recommended behavioral treatment
      but adherence to regular exercise is frequently low in individuals with cLBP, so research of
      the utility of other behavioral treatments is needed. Previous research suggests that
      reducing sitting time (or sedentary time) may improve symptoms of back pain and be beneficial
      in treating chronic low back pain. Thus, the purpose of this study is to examine the utility
      of a theory-based intervention to reduce sedentary time (Sedentary-intervention Utilizing
      Motivational Interviewing and Technology, or 'SUMIT') in individuals with cLBP. Specifically,
      the primary aim of this study is to examine the utility of SUMIT on sedentary behaviors in
      individuals with cLBP and elevated symptoms of depression. Secondary aims are to determine
      how SUMIT influences mood, pain symptoms, and pain psychophysics, and to quantify cytokine
      and endocannabinoid responses to acute exercise across the intervention. To test this,
      individuals with cLBP will either be randomized into an intervention group (n=20) or a
      wait-list control group (n=20). Additionally, healthy adults (n=20) without cLBP will be
      enrolled to serve as a pain-free control group and will not receive the intervention. All
      participants will complete baseline assessments, enroll in an 8-week intervention period,
      return for final assessments and a 3-month follow up. Over the intervention period, those in
      the intervention group will be provided with a wrist-worn activity monitor that vibrates
      after prolonged sedentariness and a behavioral intervention utilizing motivational
      interviewing and education surrounding sitting habits and strategies for new habit
      development. Individuals in the cLBP wait-list control group and pain-free control group will
      be asked to maintain current physical activity levels, sedentary behaviors, and medication
      and/or treatment for low back pain during this period. The investigators hypothesize that 1)
      objectively-monitored prolonged sedentary behavior will decrease across SUMIT and be
      maintained at follow-up, 2) cLBP symptoms, mood-related symptoms, and pain psychophysics (e.g
      pain regulation and modulation) will improve across SUMIT with maintenance of changes at
      follow-up, and 3) in response to acute exercise, cytokine and endocannabinoid responses
      post-SUMIT will become more similar to those of controls. If effective, this scalable
      intervention could be implemented as a behavioral treatment for cLBP.
    

Intervention name(s): Intervention to Reduce Sedentary Time
Intervention type(s): Behavioral
Intervention description(s): Chronic low back pain participants in the intervention group will be provided with a wrist-worn activity device that vibrates after prolonged sedentariness and meet with a health coach trained in motivational interviewing to discuss individual sedentary levels and provide education surrounding sitting habits and strategies for new habit development. Participants will meet with the health coach initially and at 4 weeks during the 8 week intervention period.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The 40 participants with chronic low back pain were randomized to either Intervention or Wait-list Control groups, while all 20 healthy control participants did not receive the intervention.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Sedentary