Clinical trial NCT06151184: Post-concussion Syndrome and Chiropractic
Official title: The Effects of Chiropractic Manual Adjustments on Nervous System Function in Individuals with Post-concussion Syndrome: a Proof of Concept Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Concussion Syndrome
Keywords: chiropractic care
spinal manipulation
heart rate variability
autonomic nervous system
electroencephalography
interlimb symmetry
impedance cardiography
electrocardiography
electrodermal activity
chiropractic adjustment
chiropractic
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention for this proof-of-concept trial is chiropractic manual adjustments. Participants will undergo chiropractic care from a state licensed chiropractor. Each individual's care plan will be determined by that individual and their specific field doctor for frequency of visits and type of chiropractic technique used. Participants will undergo 6 weeks of chiropractic for this study.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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:

1. Wearing an EEG net and then perform an event related potential after a baseline recording
2. Performing an orthostatic challenge while measuring ECG, ICG, and EDA
3. Wearing motion sensors while walking at a comfortable pace on a treadmill to evaluate interlimb symmetry and gait dynamics

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Participant recruitment
timeFrame: 24 months (recruitment period)
measure: Participant scheduling
timeFrame: 24 months (recruitment period)
measure: Participant compliance
timeFrame: 24 months (recruitment period)
measure: Participant adherence
timeFrame: 24 months (recruitment period)
measure: Participant tolerability
timeFrame: 24 months (recruitment period)
measure: Participant retention
timeFrame: 24 months (recruitment period)
measure: Assessment acceptability
timeFrame: 24 months (recruitment period)
measure: Intervention acceptability
timeFrame: 24 months (recruitment period)
measure: Data fidelity
timeFrame: 24 months (recruitment period)
measure: Implementation acceptability
timeFrame: 24 months (recruitment period)
Secondary outcomes:
measure: EEG resting state broadband power
timeFrame: Day 1
measure: EEG resting state broadband power
timeFrame: Week 2
measure: EEG resting state broadband power
timeFrame: Week 6
measure: EEG resting state functional connectivity
timeFrame: Day 1
measure: EEG resting state functional connectivity
timeFrame: Week 2
measure: EEG resting state functional connectivity
timeFrame: Week 6
measure: EEG evoked latency
timeFrame: Day 1
measure: EEG evoked latency
timeFrame: Week 2
measure: EEG evoked latency
timeFrame: Week 6
measure: ECG mean interbeat interval
timeFrame: Day 1
measure: ECG mean interbeat interval
timeFrame: Week 2
measure: ECG mean interbeat interval
timeFrame: Week 6
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: Day 1
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: Week 2
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: Week 6
measure: ECG de-trended fluctuation analysis
timeFrame: Day 1
measure: ECG de-trended fluctuation analysis
timeFrame: Week 2
measure: ECG de-trended fluctuation analysis
timeFrame: Week 6
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: Day 1
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: Week 2
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: Week 6
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: Day 1
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: Week 2
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: Week 6
measure: Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
timeFrame: Day 1
measure: Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
timeFrame: Week 2
measure: Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
timeFrame: Week 6
measure: Electrodermal activity (EDA) skin conductance level (SCL)
timeFrame: Day 1
measure: Electrodermal activity (EDA) skin conductance level (SCL)
timeFrame: Week 2
measure: Electrodermal activity (EDA) skin conductance level (SCL)
timeFrame: Week 6
measure: Composite Autonomic Symptom Score (COMPASS-31)
timeFrame: Day 1
measure: Composite Autonomic Symptom Score (COMPASS-31)
timeFrame: Week 2
measure: Composite Autonomic Symptom Score (COMPASS-31)
timeFrame: Week 6
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: Day 1
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: Week 2
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: Week 6
measure: Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)
timeFrame: Day 1
measure: Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)
timeFrame: Week 2
measure: Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)
timeFrame: Week 6
measure: Perceived Stress Scale (PSS)
timeFrame: Day 1
measure: Perceived Stress Scale (PSS)
timeFrame: Week 2
measure: Perceived Stress Scale (PSS)
timeFrame: Week 6
measure: Post-Concussion Symptom Scale
timeFrame: Day 1
measure: Post-Concussion Symptom Scale
timeFrame: Week 2
measure: Post-Concussion Symptom Scale
timeFrame: Week 6
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Dr. Sid E. Williams Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life University
name: Ahmed Qazi
role: PRINCIPAL_INVESTIGATOR
References: