Using Non-Weightbearing Stationary Elliptical Machines and Virtual Reality for Patients with Chronic Nonspecific Low Back Pain; a Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pain Visual Analogue Scale (VAS)
研究概览
简要总结
The goal of this clinical trial is to assess the effect of non-weightbearing stationary ellipticals (Cubii, Fitness Cubed, Inc.) on patient well-being with chronic lower back pain (CLBP). The main questions it aims to answer are:
- Assess the effect of non-weightbearing stationary ellipticals on clinical outcomes inclduing vital signs, pain, disability, analgesic use, mental health, abdominal muscle strength, and compliance in patients with CLBP.
- Assess the effect of placing the patients into an interactive virtual environment during the exercise sessions on the outcomes of the program
Participants will participate in 60 minute training sessions to see if there are effects to their CLBP.
详细描述
There are controversies on whether exercise is more effective than placebo among different clinical studies specifically in acute LBP; however, in CLBP cases, evidence strongly recommends that exercise is more effective than conservative treatment on pain and functional abilities, especially individually designed exercise programs for stabilizing and strengthening. The aims of the present study are:
- to assess the effect of non-weightbearing stationary ellipticals (Cubii, Fitness Cubed Inc.) on clinical outcomes including vital signs, pain, disability, analgesic use, mental health, abdominal muscle strength, and compliance in patients with CLBP
- to assess the effect of placing the patients into an interactive virtual environment during the exercise sessions on the outcomes of the program.
The training sessions will be up to 60 minutes and will include a) introduction to the goals of the session (5 minutes), b) warm-up and stretching (10 minutes), c) low resistance flat road cycling (low resistance, low cadence; 10 minutes), d) flat road cycling (high resistance, low cadence; 10 minutes), e) flat road sprint (low resistance, high cadence; 10 minutes), f) warm-down, whole-body stretching, questions and answers (Q&A; 10-15 minutes) obtained from investigations on the similar topic. The training sessions will be supervised by both an expert clinical researcher with MD degree who is familiar with healthcare principles for these patients and also by a US licensed board-certified orthopaedic surgeon, who is responsible for providing routine orthopaedic care for the patients in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
No groups will be masked
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 aged 18 to 70 years and CLBP (>12 wk) located between the costal margins and inferior gluteal folds.
排除标准
- •The presence of a postural abnormality contributing to the diagnosis reported by an expert spine surgeon
- •Pain radiating below the knee, past medical history or current symptomatic lumbar disc hernia or fracture based on expert reports (i.e. orthopedic surgeon or radiologist)
- •History of back surgery, inflammatory joint disease, severe osteoporosis
- •A metabolic disease affecting the CLBP, or neuromuscular disease (as assessed by the American College of Sports Medicine pre-exercise screening tool for cardiovascular risk factors prior to entry into an exercise program)
- •Pregnancy
- •Ankle and foot injuries inhibiting them from cycling recently (<3 mo.)
- •Participation in another exercise program or physiotherapy (i.e., manipulation, mobilization, range of motion, massage).
结局指标
主要结局
Pain Visual Analogue Scale (VAS)
时间窗: 8 weeks
Pain scores based on the Visual Analogue Scale 0-10
Pain Catastrophizing Scale (PCS)
时间窗: 8 weeks
Mental health based on the Pain Catastrophizing Scale (PCS). 13-item questionnaire to identify catastrophic thoughts or feelings in relation to painful experiences. The total score ranges from 0 to 52, with high scores indicating that more catastrophic thoughts or feelings are experienced.
Oswestry Low Back Pain Disability Index (ODI)
时间窗: 8 weeks
Measure of disability based on the Oswestry Low Back Pain Disability Index (ODI). Version 2, 10-item questionnaire on how LBP affects aspects of their life (0%-100% scoring.
Heart rate
时间窗: 8 weeks
Heart rate in beats/minute
Fear-Avoidance Beliefs Questionnaire (FABQ)
时间窗: 8 weeks
Patient's beliefs about the potential harm of work or general physical activity to their back pain. Two subscales within the FABQ have been identified, a 7-item work subscale score (FABQw, score range 0-42), and a 4-item physical activity subscale score (FABQa, score range 0-24)
Patient reported outcome measures (PROM)
时间窗: 8 weeks
PROMIS-29 profile v1.0 (for Physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social role, pain inference (+pain inference short form 6b), pain intensity, depression, mood and anxiety.
Transversus abdominis endurance (TAE)
时间窗: 8 weeks
Abdominal strength based on Transversus abdominis endurance (TAE). Holding or tonic capacity of transversus abdominis measured by the number of 10-second holds (up to 10) using pressure biofeedback in prone position.
次要结局
- Distance passed on the stationary elliptical(8 weeks)
- Satisfaction rate (0-10)(8 weeks)
- Duration of exercise in each session(8 weeks)
- Compliance (duration of continuing the sessions)(8 weeks)
- Intention to continue the sessions (0-10)(8 weeks)
- Total strides(8 weeks)
- Time series of the stride/minute(8 weeks)
- Average strides/minute(8 weeks)
- Distance traveled in each section(8 weeks)
研究者
Soheil Ashkani Esfahani
Director, Foot and Ankle Research and Innovation Laboratory
Massachusetts General Hospital