The Impact of Chiropractic on Long COVID-19

NCT ID: NCT05693064

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-08-01

Brief Summary

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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

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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 \[ECG\]

Conditions

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Long COVID

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wait-list followed by chiropractic

Group Type EXPERIMENTAL

wait-list

Intervention Type OTHER

wait-list

chiropractic adjustments

Intervention Type PROCEDURE

chiropractic adjustments

Interventions

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wait-list

wait-list

Intervention Type OTHER

chiropractic adjustments

chiropractic adjustments

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Life University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Sullivan, DC, PhD

Role: STUDY_DIRECTOR

Life Univeristy

Locations

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Lydian Chiropractic LLC

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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I-0021

Identifier Type: -

Identifier Source: org_study_id

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