NCT05693064

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
2 years until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

January 18, 2023

Last Update Submit

August 26, 2024

Conditions

Long COVID

Outcome Measures

Primary Outcomes (6)

  • 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)

  • 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

Secondary Outcomes (36)

  • EEG resting state broadband power

    Baseline (Day 1)

  • EEG resting state broadband power

    2-3 weeks on wait-list

  • EEG resting state broadband power

    8 weeks on wait-list

  • EEG resting state broadband power

    2 - 3 weeks following start of intervention

  • EEG resting state broadband power

    Post intervention

  • +31 more secondary outcomes

Study Arms (1)

Wait-list followed by chiropractic

EXPERIMENTAL
Other: wait-listProcedure: chiropractic adjustments

Interventions

wait-listOTHER

wait-list

Wait-list followed by chiropractic
chiropractic adjustmentsPROCEDURE

chiropractic adjustments

Wait-list followed by chiropractic

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Lydian Chiropractic LLC

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Waiting ListsManipulation, Chiropractic

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services AdministrationMusculoskeletal ManipulationsComplementary TherapiesTherapeutics

Study Officials

  • Stephanie Sullivan, DC, PhD

    Life Univeristy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 20, 2023

Study Start

January 15, 2025

Primary Completion

June 15, 2025

Study Completion

August 1, 2025

Last Updated

August 28, 2024

Record last verified: 2024-08

Locations

US(1)