Blinding Integrity Following a Single Session of Simulated or Genuine High Velocity, Low Amplitude (HVLA) Manual Chiropractic Adjustments: a Randomized Controlled Proof-of-concept Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Participant blinding
研究概览
简要总结
The primary aim of this trial is to assess blinding following simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments.
详细描述
The primary aim of this trial is to assess blinding following simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments. Briefly, 30 eligible participants will be randomized (1:1 ratio) to receive a single session of either simulated/sham or genuine/real chiropractic spinal adjustments and be given a brief survey immediately following their session and 48 hours later that captures their perceptions and experiences regarding the intervention they received. This study is intended to inform a future multi-session, randomized, sham-controlled trial.
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
- Single (Participant)
盲法说明
Single-blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-60 years of age
排除标准
- •History of stroke or transient ischemic attack or current symptoms including dizziness or vertigo, tinnitus (ringing in the ears), or visual, sensory, or motor disturbances
- •New pattern headache complaint
- •Recent whiplash injury (within 12 months)
- •Cervical fracture/dislocation
- •Disc problem with radiating symptoms to the arms or legs
- •Severe degenerative joint disease in the spine
- •Connective tissue disorder
- •Primary fibromyalgia
- •Metabolic or metaplastic bone disease
- •History of cervical, thoracic, or lumbar spine surgery
- •Uncontrolled high blood pressure or vascular disease
- •Current use of anticoagulant therapy
- •Doctor of Chiropractic (DC) or a DC student in 5th quarter or above
- •Present, self-reported pregnancy
结局指标
主要结局
Participant blinding
时间窗: 48 hours after intervention
The blinding index is scaled to an internal of -1 to +1, +1 being complete lack of blinding, 0 being consistent with perfect blinding, -1 indicating opposite guessing which may be related to unblinding.
次要结局
未报告次要终点