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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-concussion syndrome participants | Experimental | Post-concussion syndrome participants will all receive manual chiropractic adjustment interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiropractic adjustment | Procedure | 6 weeks of chiropractic care, with frequency and type of procedures determined by field clinician after initial examination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant recruitment | Average number of participants recruited/enrolled per month | 24 months (recruitment period) |
| Participant scheduling | Average time lag between first lab assessment & first chiropractic visit | 24 months (recruitment period) |
| Participant compliance | % of participants violating 1 or more pre-assessment lifestyle restrictions & unable/unwilling to be rescheduled | 24 months (recruitment period) |
| Participant adherence | % of participants not attending ≥80% of their chiropractic sessions | 24 months (recruitment period) |
| Participant tolerability | % of participants unable/unwilling to complete a given assessment | 24 months (recruitment period) |
| Participant retention | % of participants completing the trial | 24 months (recruitment period) |
| Assessment acceptability | Most common participant-rated acceptability score for each assessment process/procedure | 24 months (recruitment period) |
| Intervention acceptability |
| Measure | Description | Time Frame |
|---|---|---|
| EEG resting state broadband power | 64-channel hydronet cap | Day 1 |
| EEG resting state broadband power | 64-channel hydronet cap | Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Qazi | Life University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sid E. Williams Center for Chiropractic Research | Marietta | Georgia | 30067 | United States |
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| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D026882 | Manipulation, Chiropractic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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.
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Most common participant-rated acceptability score for each aspect of the chiropractic care
| 24 months (recruitment period) |
| Data fidelity | % of acquisitions from a given assessment that are unsuitable for analysis | 24 months (recruitment period) |
| Implementation acceptability | Most common clinician-rated acceptability score for each trial process/procedure | 24 months (recruitment period) |
| EEG resting state broadband power | 64-channel hydronet cap | Week 6 |
| EEG resting state functional connectivity | 64-channel hydronet cap | Day 1 |
| EEG resting state functional connectivity | 64-channel hydronet cap | Week 2 |
| EEG resting state functional connectivity | 64-channel hydronet cap | Week 6 |
| EEG evoked latency | 64-channel hydronet cap during auditory oddball task | Day 1 |
| EEG evoked latency | 64-channel hydronet cap during auditory oddball task | Week 2 |
| EEG evoked latency | 64-channel hydronet cap during auditory oddball task | Week 6 |
| ECG mean interbeat interval | 3 sensors on torso | Day 1 |
| ECG mean interbeat interval | 3 sensors on torso | Week 2 |
| ECG mean interbeat interval | 3 sensors on torso | Week 6 |
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | Day 1 |
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | Week 2 |
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | Week 6 |
| ECG de-trended fluctuation analysis | 3 sensors on torso | Day 1 |
| ECG de-trended fluctuation analysis | 3 sensors on torso | Week 2 |
| ECG de-trended fluctuation analysis | 3 sensors on torso | Week 6 |
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | Day 1 |
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | Week 2 |
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | Week 6 |
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | Day 1 |
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | Week 2 |
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | Week 6 |
| Electrodermal activity (EDA) non-specific skin conductance responses (SCR) | 2 sensors on first and second digits of non-dominant hand | Day 1 |
| Electrodermal activity (EDA) non-specific skin conductance responses (SCR) | 2 sensors on first and second digits of non-dominant hand | Week 2 |
| Electrodermal activity (EDA) non-specific skin conductance responses (SCR) | 2 sensors on first and second digits of non-dominant hand | Week 6 |
| Electrodermal activity (EDA) skin conductance level (SCL) | 2 sensors on first and second digits of non-dominant hand | Day 1 |
| Electrodermal activity (EDA) skin conductance level (SCL) | 2 sensors on first and second digits of non-dominant hand | Week 2 |
| Electrodermal activity (EDA) skin conductance level (SCL) | 2 sensors on first and second digits of non-dominant hand | Week 6 |
| Composite Autonomic Symptom Score (COMPASS-31) | 31-item questionnaire | Day 1 |
| Composite Autonomic Symptom Score (COMPASS-31) | 31-item questionnaire | Week 2 |
| Composite Autonomic Symptom Score (COMPASS-31) | 31-item questionnaire | Week 6 |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | 29-item questionnaire | Day 1 |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | 29-item questionnaire | Week 2 |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | 29-item questionnaire | Week 6 |
| Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8) | 8-item questionnaire | Day 1 |
| Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8) | 8-item questionnaire | Week 2 |
| Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog-8) | 8-item questionnaire | Week 6 |
| Perceived Stress Scale (PSS) | 10-item questionnaire | Day 1 |
| Perceived Stress Scale (PSS) | 10-item questionnaire | Week 2 |
| Perceived Stress Scale (PSS) | 10-item questionnaire | Week 6 |
| Post-Concussion Symptom Scale | 22-item questionnaire | Day 1 |
| Post-Concussion Symptom Scale | 22-item questionnaire | Week 2 |
| Post-Concussion Symptom Scale | 22-item questionnaire | Week 6 |
| D009422 |
| Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |