The Effects of Chiropractic Manual Adjustments on Nervous System Function in Individuals With Post-concussion Syndrome: a Proof of Concept Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Participant recruitment
研究概览
简要总结
This proof-of-concept trial will explore the effects of manual chiropractic adjustments on nervous system function in individuals with post-concussion syndrome. This study will aim to recruit 10 individuals to receive 6 weeks of chiropractic care with 3 assessment periods. The participants will undergo a baseline assessment, mid-trial assessment, and post-trial assessment. The participants will wear an electroencephalography (EEG) cap for a neural assessment during an event related potential. They will wear electrical diodes to measure electrocardiography (ECG), impedance cardiography (ICG), and electrodermal activity (EDA) throughout the study and during an orthostatic challenge. Additional sensors will be placed on the participant to measure interlimb symmetry patterns during gait while walking on a treadmill.
详细描述
Participants enrolled in the study will take a screening questionnaire to first determine eligibility. Once qualified, each individual will undergo a physical exam by a state licensed chiropractor to determine if there are any contraindications to undergo chiropractic care throughout the duration of the study. Each participant will receive 6 weeks of chiropractic care and will be assessed at weeks 0, 2, and 6 at the Dr. Sid E Williams Center for Chiropractic Research. Each participant will perform a number of tests to determine the evaluated function of their nervous system. In total, 3 different tests will be performed by the participant during an assessment visit that will take approximately 2.5 - 3 hours. During the assessments, each individual will be wearing electrical diodes to continually monitor ECG, ICG, and EDA. The specific assessments will be as follows:
- Wearing an EEG net and then perform an event related potential after a baseline recording
- Performing an orthostatic challenge while measuring ECG, ICG, and EDA
- Wearing motion sensors while walking at a comfortable pace on a treadmill to evaluate interlimb symmetry and gait dynamics
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 or older
- •Diagnosed by a physician with post-concussion syndrome OR self-identifies as having a concussion based on responses to the HELPS screening tool
- •Has at least 3 of the following chronic symptoms at least 3 months since concussion: headache; dizziness; insomnia; fatigue; concentration difficulty; memory difficulty; intolerance to stress, emotions, and alcohol; irritability
- •Able to understand and communicate in English
- •Able to make informed decisions without assistance
- •Can wear an EEG net for 40 minutes
- •Can sit quietly for at least 15 minutes
- •Capable of walking on a treadmill at a comfortable pace for 10 minutes consecutively
- •Capable of moving from a supine to standing to supine position quickly and safely
- •Able to wear multiple electrodes placed on chest, back, and fingertips
- •Able to wear multiple sensors placed on head, back, pelvis, hands, arms, and legs
- •Has not had a chiropractic adjustment within the last one month
- •Has not received any other interventions within the past one month such as osteopathic spinal manipulation, physical therapy rehabilitation or manipulation, massage, body movement therapies, or acupuncture
排除标准
- •Diagnosed with a serious mental disorder such as schizophrenia or bipolar disorder
- •Has malignant hypertension, which is a condition whereby their blood pressure rises suddenly and quickly
- •Has a known condition that causes syncope with postural changes, such as POTS
- •Has an implanted device (i.e., pacemaker)
- •Has a physical disability affecting their gait
- •Has a history of previous surgery or injury to the musculoskeletal structures or skull in the past three months
- •Has a prosthetic for any extremity
- •Has a hearing impairment or uses a hearing aid
- •History of stroke
- •Taking short-acting benzodiazepines, which includes midazolam and triazolam
- •Involved with current litigation related to a physical health-related injury
- •Untreated diagnosed osteoporosis or articular instability such as atlanto-axial instability
- •Currently pregnant
- •Unwilling to wash hair/head and remove hair products, accessories, braids, or wigs for assessment appointments
- •Deemed high-risk using the Columbia-Suicide Severity Rating Scale (C-SSRS) and referred for further evaluation (assessed at initial session in lab)
- •Experiences daily/chronic pain >3 out of 10 on the visual analog scale (VAS)
结局指标
主要结局
Participant recruitment
时间窗: 24 months (recruitment period)
Average number of participants recruited/enrolled per month
Participant scheduling
时间窗: 24 months (recruitment period)
Average time lag between first lab assessment \& first chiropractic visit
Participant compliance
时间窗: 24 months (recruitment period)
% of participants violating 1 or more pre-assessment lifestyle restrictions \& unable/unwilling to be rescheduled
Participant adherence
时间窗: 24 months (recruitment period)
% of participants not attending ≥80% of their chiropractic sessions
Implementation acceptability
时间窗: 24 months (recruitment period)
Most common clinician-rated acceptability score for each trial process/procedure
Participant tolerability
时间窗: 24 months (recruitment period)
% of participants unable/unwilling to complete a given assessment
Participant retention
时间窗: 24 months (recruitment period)
% of participants completing the trial
Assessment acceptability
时间窗: 24 months (recruitment period)
Most common participant-rated acceptability score for each assessment process/procedure
Intervention acceptability
时间窗: 24 months (recruitment period)
Most common participant-rated acceptability score for each aspect of the chiropractic care
Data fidelity
时间窗: 24 months (recruitment period)
% of acquisitions from a given assessment that are unsuitable for analysis
次要结局
- EEG resting state broadband power(Week 6)
- EEG resting state functional connectivity(Week 6)
- EEG evoked latency(Week 6)
- ECG mean interbeat interval(Week 6)
- ECG respiratory sinus arrhythmia (RSA)(Week 6)
- ECG de-trended fluctuation analysis(Week 6)
- Impedance cardiogram (ICG) pre-ejection period (PEP)(Week 6)
- Impedance cardiogram (ICG) initial systolic time interval (ISTI)(Week 6)
- Electrodermal activity (EDA) non-specific skin conductance responses (SCR)(Week 6)
- Electrodermal activity (EDA) skin conductance level (SCL)(Week 6)
- Composite Autonomic Symptom Score (COMPASS-31)(Week 6)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(Week 6)
- Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)(Week 6)
- Perceived Stress Scale (PSS)(Week 6)
- Post-Concussion Symptom Scale(Week 6)
研究者
Tyson Perez, DC, PhD
PI
Life University