Clinical trial NCT04257539: Reducing Sedentary Time in Chronic Low Back Pain: Sedentary Intervention Using Motivational Interviewing and Technology
Official title: Influence of Reducing Sedentary Behavior on Symptoms, Inflammation and Endocannabinoids in Patients With Chronic Low Back Pain and Elevated Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Sedentary
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Chronic low back pain (Currently experiencing low back pain every day or nearly every day for longer than 3 months)
* Elevated depressive symptoms (Patient Health Questionnaire-9 greater than or equal to 5)
* Ability to safely complete exercise session (Physical Activity Readiness Questionnaire)
* Willing to wear a physical activity tracker with an idle alert
* Regular access to computer or smartphone

Exclusion Criteria:

* Currently using activity tracker with idle alert
* Taking immunomodulatory medication
* Taking anti-depressant medication
* Changed medication or treatment in last 8 weeks
* Have injuries or conditions that prevent change in activity level
* Pregnant or planning to become pregnant during study enrollment

Primary outcomes:
measure: Change from baseline monitor-assessed sedentary time at 8 weeks
timeFrame: baseline and immediately following intervention (8 weeks)
measure: Change from baseline depressive symptoms at 8 weeks
timeFrame: baseline, immediately following intervention (8 weeks), and 3-months after intervention
measure: Change from baseline low back pain symptoms at 8 weeks
timeFrame: baseline, immediately following intervention (8 weeks), and 3-months after intervention
measure: Change from baseline pain sensitivity levels at 8 weeks
timeFrame: before exercise at baseline and immediately following intervention (8 weeks)
measure: Change from baseline pain inhibition at 8 weeks
timeFrame: after exercise at baseline and immediately following intervention (8 weeks)
measure: Change from baseline plasma cytokine levels at 8 weeks
timeFrame: before and after exercise at baseline and immediately following intervention (8 weeks)
measure: Change from baseline plasma endocannabinoid levels at 8 weeks
timeFrame: before and after exercise at baseline and immediately following intervention (8 weeks)
Secondary outcomes:
measure: Change from baseline 36-Item Short Form Survey (SF-36) scores at 8 weeks
timeFrame: baseline, immediately following intervention, and 3-months after intervention
measure: Change from baseline Profile of Mood States Short Form scores at 8 weeks
timeFrame: baseline, immediately following intervention, and 3-months after intervention
measure: Change from baseline self-reported sedentary time at 8 weeks
timeFrame: baseline, immediately following intervention, and 3-months after intervention
measure: Change from baseline monitor-assessed physical activity at 8 weeks
timeFrame: baseline and immediately following intervention
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
References: