The Impact of Chiropractic on Long COVID-19

Long COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05693064
• Other study ID #: I-0021
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: August 2023
• Source: Life University
• Contact: Austin Garlinghouse
• Phone: 770-426-2639
• Email: research.studies[@]life.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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]

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Long COVID

Intervention

Other:
• wait-list
wait-list

Procedure:
• chiropractic adjustments
chiropractic adjustments

Locations

Country	Name	City	State
United States	Lydian Chiropractic LLC	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Life University

Country where clinical trial is conducted

United States, 

Outcome

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