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

NCT ID: NCT04257539

Last Updated: 2020-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-04-06

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.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior. This will include an initial, in-person behavioral intervention with a health coach trained and a 4 week phone call. Participants will receive a wrist-worn activity prompter to aid in sedentary behavior reduction.

Group Type: EXPERIMENTAL

Intervention to Reduce Sedentary Time

Intervention Type: BEHAVIORAL

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.

Wait-list Control Group

Chronic low back pain participants in this group will not receive the intervention until completion of the study. Over the 8 week intervention period, participants will be asked to maintain currently levels of physical activity, sedentary behaviors, and treatment for low back pain.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pain-free Control Group

These subjects will be healthy, pain-free adults and receive no intervention. Over the 8 week intervention period, participants in this group will be asked to maintain currently levels of physical activity, sedentary behaviors, and medication regimen.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Iowa State University

OTHER

Sponsor Role: lead

Responsible Party

Jacob Meyer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Iowa State University

Ames, Iowa, United States

Countries

United States

Other Identifiers

18-068

Identifier Type: -

Identifier Source: org_study_id