Long COVID
Conditions
Brief summary
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
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: 1. Seated resting recording 2. Sit-to-stand test 3. Patient-reported outcome surveys Each assessment will consist of the following recordings: 1. Electroencephalography \[EEG\] 2. Impedance cardiography \[ICG\] 3. Electrocardiogram \[ECG\]
Interventions
OTHERwait-list
wait-list
PROCEDUREchiropractic adjustments
chiropractic adjustments
Sponsors
Life University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FACIT fatigue scale | Preliminary | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EEG resting state functional connectivity | Baseline (Day 1) | 256-channel hydronet cap |
| ECG mean interbeat interval | Baseline (Day 1) | 3 sensors on torso |
| ECG respiratory sinus arrhythmia (RSA) | Baseline (Day 1) | 3 sensors on torso |
| EEG resting state broadband power | Baseline (Day 1) | 256-channel hydronet cap |
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | Baseline (Day 1) | 2 sensors on chest and 2 sensors on back |
| Patient-reported outcomes | Preliminary | 4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm |
| Impedance cardiogram (ICG) pre-ejection period (PEP) | Baseline (Day 1) | 2 sensors on chest and 2 sensors on back |
Countries
United States
Outcome results
None listed