Clinical trial NCT05693064: The Impact of Chiropractic on Long COVID-19
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Long COVID
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 \[ECG\]

Eligibility 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

Primary outcomes:
measure: FACIT fatigue scale
timeFrame: Preliminary
measure: FACIT fatigue scale
timeFrame: Baseline (Day 1)
measure: FACIT fatigue scale
timeFrame: 2-3 weeks on wait-list
measure: FACIT fatigue scale
timeFrame: 8 weeks on wait-list
measure: FACIT fatigue scale
timeFrame: 2 - 3 weeks following start of intervention
measure: FACIT fatigue scale
timeFrame: Post intervention
Secondary outcomes:
measure: EEG resting state broadband power
timeFrame: Baseline (Day 1)
measure: EEG resting state broadband power
timeFrame: 2-3 weeks on wait-list
measure: EEG resting state broadband power
timeFrame: 8 weeks on wait-list
measure: EEG resting state broadband power
timeFrame: 2 - 3 weeks following start of intervention
measure: EEG resting state broadband power
timeFrame: Post intervention
measure: EEG resting state functional connectivity
timeFrame: Baseline (Day 1)
measure: EEG resting state functional connectivity
timeFrame: 2-3 weeks on wait-list
measure: EEG resting state functional connectivity
timeFrame: 8 weeks on wait-list
measure: EEG resting state functional connectivity
timeFrame: 2-3 weeks following start of intervention
measure: EEG resting state functional connectivity
timeFrame: Post intervention
measure: ECG mean interbeat interval
timeFrame: Baseline (Day 1)
measure: ECG mean interbeat interval
timeFrame: 2-3 weeks on wait-list
measure: ECG mean interbeat interval
timeFrame: 8 weeks on wait-list
measure: ECG mean interbeat interval
timeFrame: 2-3 weeks following start of intervention
measure: ECG mean interbeat interval
timeFrame: Post intervention
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: Baseline (Day 1)
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: 2-3 weeks on wait-list
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: 8 weeks on wait-list
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: 2-3 weeks following start of intervention
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: Post intervention
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: Baseline (Day 1)
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: 2-3 weeks on wait-list
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: 8 weeks on wait-list
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: 2-3 weeks following start of intervention
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: Post intervention
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: Baseline (Day 1)
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: 2-3 weeks on wait-list
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: 8 weeks on wait-list
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: 2-3 weeks following start of intervention
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: Post intervention
measure: Patient-reported outcomes
timeFrame: Preliminary
measure: Patient-reported outcomes
timeFrame: Baseline (Day 1)
measure: Patient-reported outcomes
timeFrame: 2-3 weeks on wait-list
measure: Patient-reported outcomes
timeFrame: 8 weeks on wait-list
measure: Patient-reported outcomes
timeFrame: 2-3 weeks following start of intervention
measure: Patient-reported outcomes
timeFrame: Post intervention
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Lydian Chiropractic LLC
state: Massachusetts
Study officials:
affiliation: Life Univeristy
name: Stephanie Sullivan, DC, PhD
role: STUDY_DIRECTOR
References: