An interventional study of wait-list and chiropractic adjustments in Long COVID, sponsored by Life University. Suspended at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Life University · Not applicable, Interventional, and Treatment
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.
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:
Each assessment will consist of the following recordings:
520 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 186 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 361 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Life University is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Other: wait-list · Procedure: chiropractic adjustments
wait-list
chiropractic adjustments
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Post intervention
EEG resting state broadband power
256-channel hydronet cap
Time frame: Baseline (Day 1)
EEG resting state broadband power
256-channel hydronet cap
Time frame: 2-3 weeks on wait-list
EEG resting state broadband power
256-channel hydronet cap
Time frame: 8 weeks on wait-list
EEG resting state broadband power
256-channel hydronet cap
Time frame: 2 - 3 weeks following start of intervention
EEG resting state broadband power
256-channel hydronet cap
Time frame: Post intervention
EEG resting state functional connectivity
256-channel hydronet cap
Time frame: Baseline (Day 1)
EEG resting state functional connectivity
256-channel hydronet cap
Time frame: 2-3 weeks on wait-list
EEG resting state functional connectivity
256-channel hydronet cap
Time frame: 8 weeks on wait-list
EEG resting state functional connectivity
256-channel hydronet cap
Time frame: 2-3 weeks following start of intervention
EEG resting state functional connectivity
256-channel hydronet cap
Time frame: Post intervention
ECG mean interbeat interval
3 sensors on torso
Time frame: Baseline (Day 1)
ECG mean interbeat interval
3 sensors on torso
Time frame: 2-3 weeks on wait-list
ECG mean interbeat interval
3 sensors on torso
Time frame: 8 weeks on wait-list
ECG mean interbeat interval
3 sensors on torso
Time frame: 2-3 weeks following start of intervention
ECG mean interbeat interval
3 sensors on torso
Time frame: Post intervention
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Time frame: Baseline (Day 1)
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Time frame: 2-3 weeks on wait-list
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Time frame: 8 weeks on wait-list
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Time frame: 2-3 weeks following start of intervention
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Time frame: Post intervention
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Time frame: Baseline (Day 1)
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Time frame: 2-3 weeks on wait-list
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Time frame: 8 weeks on wait-list
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Time frame: 2-3 weeks following start of intervention
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Time frame: Post intervention
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Time frame: Baseline (Day 1)
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Time frame: 2-3 weeks on wait-list
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Time frame: 8 weeks on wait-list
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Time frame: 2-3 weeks following start of intervention
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Time frame: Post intervention
Patient-reported outcomes
4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm
Time frame: Preliminary
Patient-reported outcomes
4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm
Time frame: Baseline (Day 1)
Patient-reported outcomes
4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm
Time frame: 2-3 weeks on wait-list
Patient-reported outcomes
5 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm, GRC
Time frame: 8 weeks on wait-list
Patient-reported outcomes
4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm
Time frame: 2-3 weeks following start of intervention
Patient-reported outcomes
5 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm, GRC
Time frame: Post intervention
This study is suspended, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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