The Impact of Chiropractic on Long COVID-19

Not Applicable

Suspended

• Conditions: Long COVID
• Interventions: Other: wait-list; Procedure: chiropractic adjustments

• Registration Number: NCT05693064
• Lead Sponsor: Life University

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 \[ECG\]

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Study Start: 2025-01-15
• Primary Completion: 2025-06-15
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wait-list followed by chiropractic	chiropractic adjustments	-
Wait-list followed by chiropractic	wait-list	-

Primary Outcome Measures

Name	Time	Method
FACIT fatigue scale	Post intervention	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 Outcome Measures

Name	Time	Method
EEG resting state broadband power	Post intervention	256-channel hydronet cap
ECG mean interbeat interval	Post intervention	3 sensors on torso
ECG respiratory sinus arrhythmia (RSA)	Post intervention	3 sensors on torso
EEG resting state functional connectivity	Post intervention	256-channel hydronet cap
Patient-reported outcomes	Post intervention	5 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm, GRC
Impedance cardiogram (ICG) pre-ejection period (PEP)	Post intervention	2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) initial systolic time interval (ISTI)	Post intervention	2 sensors on chest and 2 sensors on back

Trial Locations

Locations (1)

Lydian Chiropractic LLC; 🇺🇸 Cambridge, Massachusetts, United States