Post-concussion Syndrome and Chiropractic

Sponsor

Life University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06151184

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Concussion Syndrome	Procedure: Chiropractic adjustment	N/A

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:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

The Effects of Chiropractic Manual Adjustments on Nervous System Function in Individuals With Post-concussion Syndrome: a Proof of Concept Trial

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Post-concussion syndrome participants Post-concussion syndrome participants will all receive manual chiropractic adjustment interventions.	Procedure: Chiropractic adjustment 6 weeks of chiropractic care, with frequency and type of procedures determined by field clinician after initial examination.

Arm

Intervention/Treatment

Experimental: Post-concussion syndrome participants

Post-concussion syndrome participants will all receive manual chiropractic adjustment interventions.

Procedure: Chiropractic adjustment

6 weeks of chiropractic care, with frequency and type of procedures determined by field clinician after initial examination.

Outcome Measures

Primary Outcome Measures

Recruitment rate [through study completion, an average of 1 year]
Length of time required to recruit target number of participants
Participant adherence rate [through study completion, an average of 1 year]
Proportion of participants able to adhere to the testing & treatment schedule
Participant tolerability rate [through study completion, an average of 1 year]
Proportion of participants able to perform all aspects of the testing regimen
Participant retention rate [through study completion, an average of 1 year]
Proportion of enrolled participants who complete the full testing regimen
Acceptability of treatment regimen for participants [Week 6]
8-item Theoretical Framework of Acceptability questionnaire

Secondary Outcome Measures

EEG resting state broadband power [Day 1]
64-channel hydronet cap
EEG resting state broadband power [Week 2]
64-channel hydronet cap
EEG resting state broadband power [Week 6]
64-channel hydronet cap
EEG resting state functional connectivity [Day 1]
64-channel hydronet cap
EEG resting state functional connectivity [Week 2]
64-channel hydronet cap
EEG resting state functional connectivity [Week 6]
64-channel hydronet cap
EEG evoked latency [Day 1]
64-channel hydronet cap during auditory oddball task
EEG evoked latency [Week 2]
64-channel hydronet cap during auditory oddball task
EEG evoked latency [Week 6]
64-channel hydronet cap during auditory oddball task
ECG mean interbeat interval [Day 1]
3 sensors on torso
ECG mean interbeat interval [Week 2]
3 sensors on torso
ECG mean interbeat interval [Week 6]
3 sensors on torso
ECG respiratory sinus arrhythmia (RSA) [Day 1]
3 sensors on torso
ECG respiratory sinus arrhythmia (RSA) [Week 2]
3 sensors on torso
ECG respiratory sinus arrhythmia (RSA) [Week 6]
3 sensors on torso
ECG de-trended fluctuation analysis [Day 1]
3 sensors on torso
ECG de-trended fluctuation analysis [Week 2]
3 sensors on torso
ECG de-trended fluctuation analysis [Week 6]
3 sensors on torso
Impedance cardiogram (ICG) pre-ejection period (PEP) [Day 1]
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) pre-ejection period (PEP) [Week 2]
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) pre-ejection period (PEP) [Week 6]
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) initial systolic time interval (ISTI) [Day 1]
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) initial systolic time interval (ISTI) [Week 2]
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) initial systolic time interval (ISTI) [Week 6]
2 sensors on chest and 2 sensors on back
Electrodermal activity (EDA) non-specific skin conductance responses (SCR) [Day 1]
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) non-specific skin conductance responses (SCR) [Week 2]
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) non-specific skin conductance responses (SCR) [Week 6]
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) skin conductance level (SCL) [Day 1]
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) skin conductance level (SCL) [Week 2]
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) skin conductance level (SCL) [Week 6]
2 sensors on first and second digits of non-dominant hand
Composite Autonomic Symptom Score (COMPASS-31) [Day 0]
31-item questionnaire
Composite Autonomic Symptom Score (COMPASS-31) [Day 1]
31-item questionnaire
Composite Autonomic Symptom Score (COMPASS-31) [Week 2]
31-item questionnaire
Composite Autonomic Symptom Score (COMPASS-31) [Week 6]
31-item questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Day 0]
29-item questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Day 1]
29-item questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Week 2]
29-item questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Week 6]
29-item questionnaire
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8) [Day 0]
8-item questionnaire
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8) [Day 1]
8-item questionnaire
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8) [Week 2]
8-item questionnaire
Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8) [Week 6]
8-item questionnaire
Perceived Stress Scale (PSS) [Day 0]
10-item questionnaire
Perceived Stress Scale (PSS) [Day 1]
10-item questionnaire
Perceived Stress Scale (PSS) [Week 2]
10-item questionnaire
Perceived Stress Scale (PSS) [Week 6]
10-item questionnaire
Post-Concussion Symptom Scale [Day 0]
22-item questionnaire
Post-Concussion Symptom Scale [Day 1]
22-item questionnaire
Post-Concussion Symptom Scale [Week 2]
22-item questionnaire
Post-Concussion Symptom Scale [Week 6]
22-item questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 or older
Diagnosed by a physician with PCS 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 three months
Has not received any other interventions within the past three months such as osteopathic spinal manipulation, physical therapy rehabilitation or manipulation, massage, body movement therapies, or acupuncture
Able to provide the name and contact of a medical care provider (i.e., primary physician, therapist, or neurologist) they have received care from recently or in the past

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)