The Impact of Chiropractic on Long COVID-19

Study Overview
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Brief Summary
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The purpose of this waitlist-controlled, single-blind, one-way crossover, pilot trial is to evaluate the potential effects of  8 weeks of chiropractic care on patient-reported fatigue and the autonomic nervous system in adults with long COVID. This study will allow us to estimate the standard deviation of the primary endpoint in our population with which a formal power calculation for a future randomized, controlled trial can be performed.

Detailed Description
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After providing informed consent, participants will be placed on an 8-week waitlist followed by 8 weeks of chiropractic care. In-person assessments will occur 5 times: Day 1, following 2-3 weeks on waitlist, following 8 weeks on waitlist, following 2-3 weeks of chiropractic care, and following 8 weeks of chiropractic care. Patient-reported outcomes will additionally be sent prior to the first in-person assessment (Day 0). Assessments will include the following: Seated resting recording Sit-to-stand test Patient-reported outcome surveys Each assessment will consist of the following recordings: Electroencephalography [EEG] Impedance cardiography [ICG] Electrocardiogram [ECG]

Official Title
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The Impact of Chiropractic on Fatigue & the Autonomic Nervous System in Adults With Long COVID-19: a Waitlist-controlled, Single-blind, One-way Crossover, Pilot Trial

Conditions
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Long COVID

Intervention / Treatment
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* Other: wait-list
* Procedure: chiropractic adjustments


Participation Criteria
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Eligibility Criteria
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Participants will be individuals between the age of 18 and 65 who have tested positive for a COVID-19 viral infection, or SARS-CoV-2 antibodies, not less than 120 days prior to their enrollment in the study. Participants may also qualify if they have been medically diagnosed with long-COVID by their medical provider, regardless of a positive test result. They must have a T score greater than or equal to 55 on the FACIT Fatigue survey. They must also present with at least 1 of the following symptoms that cannot be explained by an alternative diagnosis, with symptom onset or exacerbation after contraction of COVID-19. Body aches/joint pain Shortness of breath or difficulty breathing Persistent chest pain or pressure Recurrent fever, chills or night sweats Headache or dizziness Difficulty concentrating or focusing Memory problems Sleep problems Anxiety or depression Heart palpitations or tachycardia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wait-list followed by chiropractic<br> | Other: wait-list<br>* wait-list<br>Procedure: chiropractic adjustments<br>* chiropractic adjustments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACIT fatigue scale | Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) | Preliminary | 
| FACIT fatigue scale | Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) | Baseline (Day 1) | 
| FACIT fatigue scale | Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) | 2-3 weeks on wait-list | 
| FACIT fatigue scale | Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) | 8 weeks on wait-list | 
| FACIT fatigue scale | Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) | 2 - 3 weeks following start of intervention | 
| FACIT fatigue scale | Patient Reported Outcome - The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued) | Post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG resting state broadband power | 256-channel hydronet cap | Baseline (Day 1) | 
| EEG resting state broadband power | 256-channel hydronet cap | 2-3 weeks on wait-list | 
| EEG resting state broadband power | 256-channel hydronet cap | 8 weeks on wait-list | 
| EEG resting state broadband power | 256-channel hydronet cap | 2 - 3 weeks following start of intervention | 
| EEG resting state broadband power | 256-channel hydronet cap | Post intervention | 
| EEG resting state functional connectivity | 256-channel hydronet cap | Baseline (Day 1) | 
| EEG resting state functional connectivity | 256-channel hydronet cap | 2-3 weeks on wait-list | 
| EEG resting state functional connectivity | 256-channel hydronet cap | 8 weeks on wait-list | 
| EEG resting state functional connectivity | 256-channel hydronet cap | 2-3 weeks following start of intervention | 
| EEG resting state functional connectivity | 256-channel hydronet cap | Post intervention | 
| ECG mean interbeat interval | 3 sensors on torso | Baseline (Day 1) | 
| ECG mean interbeat interval | 3 sensors on torso | 2-3 weeks on wait-list | 
| ECG mean interbeat interval | 3 sensors on torso | 8 weeks on wait-list | 
| ECG mean interbeat interval | 3 sensors on torso | 2-3 weeks following start of intervention | 
| ECG mean interbeat interval | 3 sensors on torso | Post intervention | 
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | Baseline (Day 1) | 
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | 2-3 weeks on wait-list | 
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | 8 weeks on wait-list | 
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | 2-3 weeks following start of intervention | 
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | Post intervention | 
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | Baseline (Day 1) | 
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | 2-3 weeks on wait-list | 
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | 8 weeks on wait-list | 
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | 2-3 weeks following start of intervention | 
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | Post intervention | 
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | Baseline (Day 1) | 
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | 2-3 weeks on wait-list | 
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | 8 weeks on wait-list | 
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | 2-3 weeks following start of intervention | 
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | Post intervention | 
| Patient-reported outcomes | 4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm | Preliminary | 
| Patient-reported outcomes | 4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm | Baseline (Day 1) | 
| Patient-reported outcomes | 4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm | 2-3 weeks on wait-list | 
| Patient-reported outcomes | 5 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm, GRC | 8 weeks on wait-list | 
| Patient-reported outcomes | 4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm | 2-3 weeks following start of intervention | 
| Patient-reported outcomes | 5 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm, GRC | Post intervention |