The Impact of Chiropractic on Long COVID-19

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

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.

Study Overview

• Status: Suspended
• Conditions: Long COVID
• Intervention / Treatment: Other: wait-list; Procedure: chiropractic adjustments

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]

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Lydian Chiropractic LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wait-list followed by chiropractic	Other: wait-list; wait-list; Procedure: chiropractic adjustments; chiropractic adjustments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Life University
• Investigators: Study Director: Stephanie Sullivan, DC, PhD, Life Univeristy

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: I-0021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No