The Impact of Chiropractic on Long COVID-19

Life University

Status: Suspended

Conditions: Long COVID

Treatments: Procedure: chiropractic adjustments; Other: wait-list

Study type: Interventional

Funder types: Other

Identifiers

NCT05693064

I-0021

Details and patient eligibility

About

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.

Full 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]

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Wait-list followed by chiropractic

Experimental group

Treatment:

Procedure: chiropractic adjustments

Other: wait-list