The Impact of Chiropractic on Long COVID-19
Purpose
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.
Condition
- Long COVID
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Wait-list followed by chiropractic |
|
Recruiting Locations
More Details
- NCT ID
- NCT05693064
- Status
- Suspended
- Sponsor
- Life University
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]