Phase 2 RCT Automatic Thermomechanical Massage Bed for Acute Pain Relief for Chronic Nonspecific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The 100mm Visual Analogue Scale for Pain
研究概览
简要总结
This prospective, double-blinded, sham-control, parallel-arm, randomized pilot trial will recruit n=40 participants, ages 18-65 (inclusive), with chronic low back pain (LBP) in the lower region, to be randomly assigned using 1:1 randomization method to receive a 40-minute single session of either active or sham Automated Thermo-mechanical Therapy (ATT). All research procedures, including informed consent, ATT session, and pre- and post-ATT assessments, will be completed in one single session.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 65
- •Has had chronic non-specific lower back pain persisting for 12 weeks or more
- •Conversational level of English
排除标准
- •Contraindications to mechanical manipulation of the back
- •History of back surgery within the past three years
- •Recent back injury
- •Presence of back implants or active implanted devices
- •Low back pain resulting from other specific conditions (e.g., infection, neoplasm)
- •Sensitivity to heat
- •Circulatory insufficiency
- •Heart disease
- •Pregnant or breastfeeding
- •Individuals with a history of substance use disorder
- •Body weight over 298 lbs (135 kg)
结局指标
主要结局
The 100mm Visual Analogue Scale for Pain
时间窗: Immediately before and immediately after intervention
The VAS-P100 is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients. The 100-mm VAS-P is a straight horizontal line of fixed length of 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (best) to the right (worst). The participant marks on the line the point that they feel represents their perception of their current state. The score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks
次要结局
- Roland-Morris Disability Questionnaire(Immediately before intervention)
- McGill Pain Questionnaire(Immediately before intervention and immediately after intervention)
- State-Trait Anxiety Inventory(Immediately before and immediately after intervention)
- 5-point Verbal Rating Scale for Pain Relief(Immediately after intervention)
- Modified-Modified Schöber Test(Immediately before and immediately after intervention)
研究者
Marom Bikson
Professor
The City College of New York