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

NCT04257539 | Completed

• 1 other identifier: 18-068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Sedentary

Outcome Measures

Primary Outcomes (7)

• Change from baseline monitor-assessed sedentary time at 8 weeks

  Average daily sedentary time in bouts longer than 60 minutes assessed using thigh worn activPAL monitors. The activPAL classifies time into sedentary, upright and stepping, has been validated for measuring free-living sedentary behaviors and is sensitive to changes in these behaviors.

  baseline and immediately following intervention (8 weeks)

• Change from baseline depressive symptoms at 8 weeks

  The Patient Health Questionnaire (PHQ-9), consisting of 9 questions, will be used for participants to report the presence and severity of depressive symptoms over the past 2 weeks. PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.

  baseline, immediately following intervention (8 weeks), and 3-months after intervention

• Change from baseline low back pain symptoms at 8 weeks

  The Minimal Dataset for Low Back Pain will be used for participants to report current symptoms of low back pain and impact on daily life. On this questionnaire, for each item a score of 1 is least severe and 5 most severe, with the exception of the single item on pain intensity, which ranges from 0 (no pain) to 10 (worst possible pain). Total scores range from 8 (least impact) to 50 (most impact).

  baseline, immediately following intervention (8 weeks), and 3-months after intervention

• Change from baseline pain sensitivity levels at 8 weeks

  Pain sensitivity will be asesssed using the Medoc Pathway Pain \& Sensory Evaluation System and applying thermal stimuli to the palm of the non-dominant hand. Subjects will be randomly presented temperatures ranging from 41°to 49°C and asked to rate each stimulus using two separate category-ratio scales to assess pain intensity and unpleasantness.

  before exercise at baseline and immediately following intervention (8 weeks)

• Change from baseline pain inhibition at 8 weeks

  Exercise-induced hypoalgesia (EIH) will be used to assess pain inhibition. EIH will be tested by re-administering the pain-sensitivity protocol post exercise.

  after exercise at baseline and immediately following intervention (8 weeks)

• Change from baseline plasma cytokine levels at 8 weeks

  Blood samples will be collected and processed to determine concentrations of IL-6 and TNF-alpha.

  before and after exercise at baseline and immediately following intervention (8 weeks)

• Change from baseline plasma endocannabinoid levels at 8 weeks

  Blood samples will be collected and processed to determine levels of anandamide(AEA) and 2-arachidonoylglycerol (2-AG).

  before and after exercise at baseline and immediately following intervention (8 weeks)

Secondary Outcomes (4)

• Change from baseline 36-Item Short Form Survey (SF-36) scores at 8 weeks

  baseline, immediately following intervention, and 3-months after intervention

• Change from baseline Profile of Mood States Short Form scores at 8 weeks

  baseline, immediately following intervention, and 3-months after intervention

• Change from baseline self-reported sedentary time at 8 weeks

  baseline, immediately following intervention, and 3-months after intervention

• Change from baseline monitor-assessed physical activity at 8 weeks

  baseline and immediately following intervention

Study Arms (3)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Intervention to Reduce Sedentary Time

Wait-list Control Group

NO INTERVENTION

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.

Pain-free Control Group

NO INTERVENTION

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.

Interventions

Intervention to Reduce Sedentary Time 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.

Intervention Group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iowa State University: lead

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator was masked to treatment group and all analyses were performed on masked data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 6, 2020
• Study Start: April 1, 2018
• Primary Completion: February 3, 2020
• Study Completion: April 6, 2020
• Last Updated: August 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)