Post-concussion Syndrome and Chiropractic

Post-Concussion Syndrome Clinical Trial

— PCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151184
• Other study ID #: I-0025
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Life University
• Contact: Austin Garlinghouse
• Phone: 7704262639
• Email: research.studies[@]life.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

• Pain on the day of testing rated higher than 3/10 on a visual analog scale (VAS)

Related Conditions & MeSH terms

• Post-Concussion Syndrome
• Syndrome

Intervention

Procedure:
• Chiropractic adjustment
6 weeks of chiropractic care, with frequency and type of procedures determined by field clinician after initial examination.

Locations

Country	Name	City	State
United States	Dr. Sid E. Williams Center for Chiropractic Research	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Life University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant recruitment	Average number of participants recruited/enrolled per month	6 months (recruitment period)
Primary	Participant scheduling	Average time lag between first lab assessment & first chiropractic visit	6 months (recruitment period)
Primary	Participant compliance	% of participants violating 1 or more pre-assessment lifestyle restrictions & unable/unwilling to be rescheduled	6 months (recruitment period)
Primary	Participant adherence	% of participants not attending =80% of their chiropractic sessions	6 months (recruitment period)
Primary	Participant tolerability	% of participants unable/unwilling to complete a given assessment	6 months (recruitment period)
Primary	Participant retention	% of participants completing the trial	6 months (recruitment period)
Primary	Assessment acceptability	Most common participant-rated acceptability score for each assessment process/procedure	6 months (recruitment period)
Primary	Intervention acceptability	Most common participant-rated acceptability score for each aspect of the chiropractic care	6 months (recruitment period)
Primary	Data fidelity	% of acquisitions from a given assessment that are unsuitable for analysis	6 months (recruitment period)
Primary	Implementation acceptability	Most common clinician-rated acceptability score for each trial process/procedure	6 months (recruitment period)
Secondary	EEG resting state broadband power	64-channel hydronet cap	Day 1
Secondary	EEG resting state broadband power	64-channel hydronet cap	Week 2
Secondary	EEG resting state broadband power	64-channel hydronet cap	Week 6
Secondary	EEG resting state functional connectivity	64-channel hydronet cap	Day 1
Secondary	EEG resting state functional connectivity	64-channel hydronet cap	Week 2
Secondary	EEG resting state functional connectivity	64-channel hydronet cap	Week 6
Secondary	EEG evoked latency	64-channel hydronet cap during auditory oddball task	Day 1
Secondary	EEG evoked latency	64-channel hydronet cap during auditory oddball task	Week 2
Secondary	EEG evoked latency	64-channel hydronet cap during auditory oddball task	Week 6
Secondary	ECG mean interbeat interval	3 sensors on torso	Day 1
Secondary	ECG mean interbeat interval	3 sensors on torso	Week 2
Secondary	ECG mean interbeat interval	3 sensors on torso	Week 6
Secondary	ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Day 1
Secondary	ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Week 2
Secondary	ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Week 6
Secondary	ECG de-trended fluctuation analysis	3 sensors on torso	Day 1
Secondary	ECG de-trended fluctuation analysis	3 sensors on torso	Week 2
Secondary	ECG de-trended fluctuation analysis	3 sensors on torso	Week 6
Secondary	Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Day 1
Secondary	Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Week 2
Secondary	Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Week 6
Secondary	Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Day 1
Secondary	Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Week 2
Secondary	Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Week 6
Secondary	Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Day 1
Secondary	Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Week 2
Secondary	Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Week 6
Secondary	Electrodermal activity (EDA) skin conductance level (SCL)	2 sensors on first and second digits of non-dominant hand	Day 1
Secondary	Electrodermal activity (EDA) skin conductance level (SCL)	2 sensors on first and second digits of non-dominant hand	Week 2
Secondary	Electrodermal activity (EDA) skin conductance level (SCL)	2 sensors on first and second digits of non-dominant hand	Week 6
Secondary	Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Day 0
Secondary	Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Day 1
Secondary	Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Week 2
Secondary	Composite Autonomic Symptom Score (COMPASS-31)	31-item questionnaire	Week 6
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-29)	29-item questionnaire	Day 0
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-29)	29-item questionnaire	Day 1
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-29)	29-item questionnaire	Week 2
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-29)	29-item questionnaire	Week 6
Secondary	Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)	8-item questionnaire	Day 0
Secondary	Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)	8-item questionnaire	Day 1
Secondary	Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)	8-item questionnaire	Week 2
Secondary	Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8)	8-item questionnaire	Week 6
Secondary	Perceived Stress Scale (PSS)	10-item questionnaire	Day 0
Secondary	Perceived Stress Scale (PSS)	10-item questionnaire	Day 1
Secondary	Perceived Stress Scale (PSS)	10-item questionnaire	Week 2
Secondary	Perceived Stress Scale (PSS)	10-item questionnaire	Week 6
Secondary	Post-Concussion Symptom Scale	22-item questionnaire	Day 0
Secondary	Post-Concussion Symptom Scale	22-item questionnaire	Day 1
Secondary	Post-Concussion Symptom Scale	22-item questionnaire	Week 2
Secondary	Post-Concussion Symptom Scale	22-item questionnaire	Week 6