Long COVIDNCT05693064
The Impact of Chiropractic on Long COVID-19
A study testing wait-list and chiropractic adjustments in people with Long COVID, run by Life University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID
- What is being tested?
- wait-list and chiropractic adjustments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
Lydian Chiropractic LLC
Cambridge, Massachusetts, 02138
About this study
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
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.
Read the 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:
- Seated resting recording
- Sit-to-stand test
- Patient-reported outcome surveys
Each assessment will consist of the following recordings:
- Electroencephalography [EEG]
- Impedance cardiography [ICG]
- Electrocardiogram [ECG]
- Conditions
- Long COVID
- Being tested
- wait-list, chiropractic adjustments
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wait-listOther
wait-list
chiropractic adjustmentsProcedure or surgery
chiropractic adjustments
| Study group | Role | What they receive |
|---|---|---|
| Wait-list followed by chiropractic | Experimental | Not described Receives: Other: wait-list; Procedure: chiropractic adjustments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Baseline (Day 1)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Post intervention
Secondary outcomes (36)
EEG resting state broadband power
256-channel hydronet cap
Measured: Baseline (Day 1)
EEG resting state broadband power
256-channel hydronet cap
Measured: 2-3 weeks on wait-list
EEG resting state broadband power
256-channel hydronet cap
Measured: 8 weeks on wait-list
EEG resting state broadband power
256-channel hydronet cap
Measured: 2 - 3 weeks following start of intervention
EEG resting state broadband power
256-channel hydronet cap
Measured: Post intervention
EEG resting state functional connectivity
256-channel hydronet cap
Measured: Baseline (Day 1)
EEG resting state functional connectivity
256-channel hydronet cap
Measured: 2-3 weeks on wait-list
EEG resting state functional connectivity
256-channel hydronet cap
Measured: 8 weeks on wait-list
EEG resting state functional connectivity
256-channel hydronet cap
Measured: 2-3 weeks following start of intervention
EEG resting state functional connectivity
256-channel hydronet cap
Measured: Post intervention
ECG mean interbeat interval
3 sensors on torso
Measured: Baseline (Day 1)
ECG mean interbeat interval
3 sensors on torso
Measured: 2-3 weeks on wait-list
ECG mean interbeat interval
3 sensors on torso
Measured: 8 weeks on wait-list
ECG mean interbeat interval
3 sensors on torso
Measured: 2-3 weeks following start of intervention
ECG mean interbeat interval
3 sensors on torso
Measured: Post intervention
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Measured: Baseline (Day 1)
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Measured: 2-3 weeks on wait-list
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Measured: 8 weeks on wait-list
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Measured: 2-3 weeks following start of intervention
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
Measured: Post intervention
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Measured: Baseline (Day 1)
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Measured: 2-3 weeks on wait-list
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Measured: 8 weeks on wait-list
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Measured: 2-3 weeks following start of intervention
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Measured: Post intervention
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Measured: Baseline (Day 1)
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Measured: 2-3 weeks on wait-list
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Measured: 8 weeks on wait-list
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Measured: 2-3 weeks following start of intervention
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Measured: Post intervention
Patient-reported outcomes
4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm
Measured: Preliminary
Patient-reported outcomes
4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm
Measured: Baseline (Day 1)
Patient-reported outcomes
4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm
Measured: 2-3 weeks on wait-list
Patient-reported outcomes
5 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm, GRC
Measured: 8 weeks on wait-list
Patient-reported outcomes
4 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm
Measured: 2-3 weeks following start of intervention
Patient-reported outcomes
5 questionnaires - MFSI, IPAQ-S, PSS-4, C19-YRSm, GRC
Measured: Post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start15 Jan 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Why it stopped: Funding is needed before continuing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Sullivan, DC, PhD, Study director, Life Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693064
- Sponsor's protocol ID
- I-0021
- Status last verified
- Aug 2024
- First submitted
- 18 Jan 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05693064
- Acronym / sponsor ID
- I-0021
- Conditions
- Long COVID
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding is needed before continuing
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Seated resting recording
- Sit-to-stand test
- Patient-reported outcome surveys
Each assessment will consist of the following recordings:
- Electroencephalography [EEG]
- Impedance cardiography [ICG]
- Electrocardiogram [ECG]
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wait-list followed by chiropractic | Experimental | Other: wait-list, Procedure: chiropractic adjustments |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wait-listwait-list | Other | Wait-list followed by chiropractic |
| chiropractic adjustmentschiropractic adjustments | Procedure or surgery | Wait-list followed by chiropractic |
Primary outcome
FACIT fatigue scale
Time frame: Preliminary
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)
FACIT fatigue scale
Time frame: Baseline (Day 1)
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)
FACIT fatigue scale
Time frame: 2-3 weeks on wait-list
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)
FACIT fatigue scale
Time frame: 8 weeks on wait-list
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)
FACIT fatigue scale
Time frame: 2 - 3 weeks following start of 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)
FACIT fatigue scale
Time frame: 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)
36 secondary outcomes
EEG resting state broadband power
Time frame: Baseline (Day 1)
EEG resting state broadband power
Time frame: 2-3 weeks on wait-list
EEG resting state broadband power
Time frame: 8 weeks on wait-list
EEG resting state broadband power
Time frame: 2 - 3 weeks following start of intervention
EEG resting state broadband power
Time frame: Post intervention
EEG resting state functional connectivity
Time frame: Baseline (Day 1)
EEG resting state functional connectivity
Time frame: 2-3 weeks on wait-list
EEG resting state functional connectivity
Time frame: 8 weeks on wait-list
EEG resting state functional connectivity
Time frame: 2-3 weeks following start of intervention
EEG resting state functional connectivity
Time frame: Post intervention
ECG mean interbeat interval
Time frame: Baseline (Day 1)
ECG mean interbeat interval
Time frame: 2-3 weeks on wait-list
ECG mean interbeat interval
Time frame: 8 weeks on wait-list
ECG mean interbeat interval
Time frame: 2-3 weeks following start of intervention
ECG mean interbeat interval
Time frame: Post intervention
ECG respiratory sinus arrhythmia (RSA)
Time frame: Baseline (Day 1)
ECG respiratory sinus arrhythmia (RSA)
Time frame: 2-3 weeks on wait-list
ECG respiratory sinus arrhythmia (RSA)
Time frame: 8 weeks on wait-list
ECG respiratory sinus arrhythmia (RSA)
Time frame: 2-3 weeks following start of intervention
ECG respiratory sinus arrhythmia (RSA)
Time frame: Post intervention
Impedance cardiogram (ICG) pre-ejection period (PEP)
Time frame: Baseline (Day 1)
Impedance cardiogram (ICG) pre-ejection period (PEP)
Time frame: 2-3 weeks on wait-list
Impedance cardiogram (ICG) pre-ejection period (PEP)
Time frame: 8 weeks on wait-list
Impedance cardiogram (ICG) pre-ejection period (PEP)
Time frame: 2-3 weeks following start of intervention
Impedance cardiogram (ICG) pre-ejection period (PEP)
Time frame: Post intervention
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Time frame: Baseline (Day 1)
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Time frame: 2-3 weeks on wait-list
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Time frame: 8 weeks on wait-list
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Time frame: 2-3 weeks following start of intervention
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Time frame: Post intervention
Patient-reported outcomes
Time frame: Preliminary
Patient-reported outcomes
Time frame: Baseline (Day 1)
Patient-reported outcomes
Time frame: 2-3 weeks on wait-list
Patient-reported outcomes
Time frame: 8 weeks on wait-list
Patient-reported outcomes
Time frame: 2-3 weeks following start of intervention
Patient-reported outcomes
Time frame: Post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Sullivan, DC, PhD study director
Life Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wait-list and chiropractic adjustments in people with Long COVID, run by Life University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACIT fatigue scale (time frame: Preliminary). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.