Influence of Reducing Sedentary Behavior on Symptoms, Inflammation and Endocannabinoids in Patients With Chronic Low Back Pain and Elevated Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline pain sensitivity levels at 8 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The investigator was masked to treatment group and all analyses were performed on masked data.
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline pain sensitivity levels at 8 weeks
时间窗: before exercise at baseline and immediately following intervention (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.
Change from baseline pain inhibition at 8 weeks
时间窗: after exercise at baseline and immediately following intervention (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.
Change from baseline monitor-assessed sedentary time at 8 weeks
时间窗: baseline and immediately following intervention (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.
Change from baseline plasma cytokine levels at 8 weeks
时间窗: before and after exercise at baseline and immediately following intervention (8 weeks)
Blood samples will be collected and processed to determine concentrations of IL-6 and TNF-alpha.
Change from baseline depressive symptoms at 8 weeks
时间窗: baseline, immediately following intervention (8 weeks), and 3-months after intervention
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.
Change from baseline low back pain symptoms at 8 weeks
时间窗: baseline, immediately following intervention (8 weeks), and 3-months after intervention
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).
Change from baseline plasma endocannabinoid levels at 8 weeks
时间窗: before and after exercise at baseline and immediately following intervention (8 weeks)
Blood samples will be collected and processed to determine levels of anandamide(AEA) and 2-arachidonoylglycerol (2-AG).
次要结局
- 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 36-Item Short Form Survey (SF-36) 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)
研究者
Jacob Meyer
Assistant Professor
Iowa State University