Blinding Integrity Following Multiple Sessions of Simulated or Genuine High Velocity, Low Amplitude (HVLA) Manual Chiropractic Adjustments: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Participant blinding
研究概览
简要总结
Our primary aim with this trial is to measure participant blinding following two simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments to assess if participants are able to identify their un-disclosed treatment group. Our secondary aims with this trial are to utilize electrocardiography (ECG), impedance cardiography (ICG), and gait analysis before either treatment session and after both treatment sessions to assess if there are any changes with the participants' measurements before and after a sham or genuine HVLA chiropractic treatment.
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, 60 eligible participants will be randomized (1:1 ratio) to receive two sessions of either simulated/sham or genuine/real chiropractic spinal adjustments with a 1 week washout between each treatment. The participants will be given a brief survey immediately following their first and second sessions, as well as immediately prior to the second session. This survey captures their perceptions and experiences regarding the intervention they received. The participants will also complete a pre- and post-electrocardiogram (ECG), impedance cardiography (ICG), and gait analysis. The participant will wear electrical diodes to assess ECG and ICG. Additional sensors will be placed on the participant to assess gait patterns while walking on a treadmill.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Lab coordinator
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
- •No history of stroke or transient ischemic attack or current symptoms including: Dizziness or vertigo; Tinnitus (ringing in the ears); Visual, sensory, or motor disturbances
- •No new pattern headache complaint
- •No recent whiplash injury (within 3 mo)
- •No spinal fractures/dislocations
- •No disc problems with radiating symptoms to the arms or legs
- •No severe degenerative joint disease in the spine
- •No connective tissue disorders
- •No primary fibromyalgia
- •No metabolic or metaplastic bone disease
- •No diagnosed condition that causes fainting during postural changes, such as POTS or orthostatic hypotension
- •No history of cervical, thoracic, or lumbar spine surgery
- •No uncontrolled high blood pressure or vascular disease
- •No current use of anticoagulant therapy
- •No current use of short-acting benzodiazepines, including midazolam & triazolam
- •No change in medications in the past 6 weeks or intentions to change medications during the study
- •Inability to walk unassisted on a treadmill
- •No pacemakers or known heart conditions that influence the electrical or mechanical function of the heart, such as severe heart valve disease
- •Not a DC or a DC student enrolled 4th quarter or above
- •No present, self-reported pregnancy
- •No chiropractic care in the 2 weeks prior to participation
- •Did not participate in the feasibility study for this pilot (Perceptions and experiences following a single session of simulated or genuine high velocity, low amplitude (HVLA) manual chiropractic adjustments)
排除标准
- 未提供
研究组 & 干预措施
Simulated/sham
30 individuals receiving simulated/sham chiropractic interventions
干预措施: Sham adjustment (Procedure)
Genuine/real
30 individuals receiving genuine/real chiropractic interventions
干预措施: Chiropractic adjustment (Procedure)
结局指标
主要结局
Participant blinding
时间窗: Immediately post-session 2 (day 2)
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.
Participant blinding
时间窗: Immediately post-session 1 (day 1)
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.
Participant blinding
时间窗: Immediately pre-session 2 (day 2)
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
- High-frequency Heart Rate Variability (HF-HRV)(post-session 2 (day 2))
- Pre-ejection period (PEP)(post-session 2 (day 2))
- The speed of the participants will be assessed at baseline as part of the gait analysis.(baseline)
- The speed of the participants will be assessed again at post-session 2 as part of the gait analysis.(post-session 2 (day 2))
- Force measurements generated during walking will be assessed at baseline as part of the gait analysis.(baseline)
- Force measurements generated during walking will be assessed again at post-session 2 as part of the gait analysis.(post-session 2 (day 2))
- Gait symmetry will be assessed at baseline as part of the gait analysis.(baseline)
- Gait symmetry will be assessed again at post-session 2 as part of the gait analysis.(post-session 2 (day 2))
- Root Mean Square of Successive Differences (RMSSD)(post-session 2 (day 2))
- High-frequency Heart Rate Variability (HF-HRV)(baseline)
- Pre-ejection period (PEP)(baseline)
- Root Mean Square of Successive Differences (RMSSD)(baseline)