Identifying Brain Mechanisms Related to Body Awareness Using QiGong to Relieve Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Revised Body Awareness Rating Questionnaire (BARQ)
研究概览
简要总结
The long-term objective of this investigation is to identify how Qigong affects brain function in brain areas relevant to patients with chronic low back pain (cLBP), thereby setting a foundation from which to perform further clinical research.
详细描述
The central hypothesis of this investigation is that, in adults with cLBP, practicing Qigong compared to exercise will result in reduced pain and improved body awareness and proprioception (primary behavioral endpoints), disability, balance, core muscle strength, and other CLBP symptoms will be secondary behavioral endpoints.To test this hypothesis, the investigators will assess (1) participant recruitment and retention ; (2) adherence to interventions, engagement/satisfaction with the program; and (3) changes in body awareness-related brain activation and connectivity pre-post intervention (Qigong vs exercise) related to primary endpoints of pain perception, body awareness and objective measures of lower limb proprioception.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Adults with chronic low back pain
排除标准
- •Those with cognitive problems
- •Those unable to speak or understand instructions
- •Those who have nerve problems, fractures, or infections
- •Those who do not speak English
- •Those with severe deficit in motor imagery or in vision (both are used in MRI tasks)
结局指标
主要结局
Change in Revised Body Awareness Rating Questionnaire (BARQ)
时间窗: baseline, 15 weeks
The Body Awareness Rating Questionnaire (BARQ) is a self-report questionnaire designed to capture how individuals with long-lasting musculoskeletal pain reflect on their own body awareness. This questionnaire contains 12 items rated on a scale from 0 (completely disagree) to 3 (completely agree). The total score is a sum of all items. Lower scores indicate greater body awareness.
Change in Mindfulness Attention Awareness Scale (MAAS)
时间窗: baseline, 15 weeks
The MAAS is a 15-item scale designed to assess a core characteristic of mindfulness. Items are rated on a scale from 1 (almost always) to 6 (almost never). The total score is an unweighted mean of the 15 item scores.
Change in Postural Awareness Scale (PAS)
时间窗: baseline, 15 weeks
The PAS is a 12-item scale, which was developed in order to measure self-reported awareness of body posture in patients with chronic pain and to evaluate potential changes in postural awareness induced by a multimodal mind-body training program. Item responses range from 1 (not at all true about me) to 7 (very true about me). Six items are reversely scored, so that higher score values consistently indicate higher postural awareness. Total scores are a sum of items scores and range from 13 to 91, with higher scores indicating greater postural awareness
Change in Pain Numeric Rating Scale (NRS)
时间窗: baseline, 15 weeks
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. Pain is rated on a scale of 0-10, with higher scores indicating greater pain intensity.
Change in Five-Facet Mindfulness Questionnaire (FFMQ)
时间窗: baseline, 15 weeks
The FFMQ is a 39-item scale measuring five facets of mindfulness: observing (items 1, 6, 11, 15, 20, 26, 31, and 36), describing (items 2, 7, 12R, 16R, 22R, 27, 32, and 37), acting with awareness (items 5R, 8R, 13R, 18R, 23R, 28R, 34R, 38R), non-judging of inner experience (items 3R, 10R, 14R, 17R, 25R, 30R, 35R, 39R), and non-reactivity to inner experience (items 4, 9, 19, 21, 24, 33). Items are rated on a scale from 1 (never or very rarely true) to 5 (very often or always true). Items marked with "R" are scored in reverse. Sub scale and total scale scores can be calculated by sum or unweighted mean. Higher scores indicate higher levels of mindfulness.
Change in Proprioception
时间窗: baseline, 15 weeks
Lower-limb proprioception will be measured by a lower limb device that produces assessment of proprioceptive acuity and sensitivity of the ankle and/or knee joint in the sagittal plane. Output is measured in degrees of joint motion of the ankle and knee.
次要结局
- Change in Pain Self-Efficacy questionnaire (PSEQ)(baseline, 15 weeks)
- Change in Tampa Scale for Kinesiophobia(baseline, 15 weeks)
- Change in Core Muscle Stabilization - Supine(baseline, 15 weeks)
- Change in Core Muscle Stabilization - Prone(baseline, 15 weeks)
- Change in Balance Test - Left Leg(baseline, 15 weeks)
- Change in Balance Test - Right Leg(baseline, 15 weeks)
- Change in Modified Roland Morris Disability Questionnaire(baseline, 15 weeks)
- Change in Fear-Avoidance Beliefs Questionnaire (FABQ)(baseline, 15 weeks)