NCT04257539

Reducing Sedentary Time in Chronic Low Back Pain: Sedentary Intervention Using Motivational Interviewing and Technology

Influence of Reducing Sedentary Behavior on Symptoms, Inflammation and Endocannabinoids in Patients With Chronic Low Back Pain and Elevated Depressive Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Iowa State University · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
BEHAVIORAL	Intervention to Reduce Sedentary Time	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.

Timeline

• Start date: 2018-04-01
• Primary completion: 2020-02-03
• Completion: 2020-04-06
• First posted: 2020-02-06
• Last updated: 2020-08-10

Locations

1 site across 1 country: United States