Post-concussion Syndrome and Chiropractic

NCT ID: NCT06151184

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-27
• Study Completion Date: 2026-07-31

Brief Summary

This proof-of-concept trial will explore the effects of manual chiropractic adjustments on nervous system function in individuals with post-concussion syndrome. This study will aim to recruit 10 individuals to receive 6 weeks of chiropractic care with 3 assessment periods. The participants will undergo a baseline assessment, mid-trial assessment, and post-trial assessment. The participants will wear an electroencephalography (EEG) cap for a neural assessment during an event related potential. They will wear electrical diodes to measure electrocardiography (ECG), impedance cardiography (ICG), and electrodermal activity (EDA) throughout the study and during an orthostatic challenge. Additional sensors will be placed on the participant to measure interlimb symmetry patterns during gait while walking on a treadmill.

Detailed Description

Participants enrolled in the study will take a screening questionnaire to first determine eligibility. Once qualified, each individual will undergo a physical exam by a state licensed chiropractor to determine if there are any contraindications to undergo chiropractic care throughout the duration of the study. Each participant will receive 6 weeks of chiropractic care and will be assessed at weeks 0, 2, and 6 at the Dr. Sid E Williams Center for Chiropractic Research. Each participant will perform a number of tests to determine the evaluated function of their nervous system. In total, 3 different tests will be performed by the participant during an assessment visit that will take approximately 2.5 - 3 hours. During the assessments, each individual will be wearing electrical diodes to continually monitor ECG, ICG, and EDA. The specific assessments will be as follows:

1. Wearing an EEG net and then perform an event related potential after a baseline recording

2. Performing an orthostatic challenge while measuring ECG, ICG, and EDA

3. Wearing motion sensors while walking at a comfortable pace on a treadmill to evaluate interlimb symmetry and gait dynamics

Conditions

Post-Concussion Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Post-concussion syndrome participants

Post-concussion syndrome participants will all receive manual chiropractic adjustment interventions.

Group Type: EXPERIMENTAL

Chiropractic adjustment

Intervention Type: PROCEDURE

6 weeks of chiropractic care, with frequency and type of procedures determined by field clinician after initial examination.

Interventions

Chiropractic adjustment

6 weeks of chiropractic care, with frequency and type of procedures determined by field clinician after initial examination.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 18 or older
• Diagnosed by a physician with post-concussion syndrome OR self-identifies as having a concussion based on responses to the HELPS screening tool
• Has at least 3 of the following chronic symptoms at least 3 months since concussion: headache; dizziness; insomnia; fatigue; concentration difficulty; memory difficulty; intolerance to stress, emotions, and alcohol; irritability
• Able to understand and communicate in English
• Able to make informed decisions without assistance
• Can wear an EEG net for 40 minutes
• Can sit quietly for at least 15 minutes
• Capable of walking on a treadmill at a comfortable pace for 10 minutes consecutively
• Capable of moving from a supine to standing to supine position quickly and safely
• Able to wear multiple electrodes placed on chest, back, and fingertips
• Able to wear multiple sensors placed on head, back, pelvis, hands, arms, and legs
• Has not had a chiropractic adjustment within the last one month
• Has not received any other interventions within the past one month such as osteopathic spinal manipulation, physical therapy rehabilitation or manipulation, massage, body movement therapies, or acupuncture

Exclusion Criteria

• Diagnosed with a serious mental disorder such as schizophrenia or bipolar disorder
• Has malignant hypertension, which is a condition whereby their blood pressure rises suddenly and quickly
• Has a known condition that causes syncope with postural changes, such as POTS
• Has an implanted device (i.e., pacemaker)
• Has a physical disability affecting their gait
• Has a history of previous surgery or injury to the musculoskeletal structures or skull in the past three months
• Has a prosthetic for any extremity
• Has a hearing impairment or uses a hearing aid
• History of stroke
• Taking short-acting benzodiazepines, which includes midazolam and triazolam
• Involved with current litigation related to a physical health-related injury
• Untreated diagnosed osteoporosis or articular instability such as atlanto-axial instability
• Currently pregnant
• Unwilling to wash hair/head and remove hair products, accessories, braids, or wigs for assessment appointments
• Deemed high-risk using the Columbia-Suicide Severity Rating Scale (C-SSRS) and referred for further evaluation (assessed at initial session in lab)
• Experiences daily/chronic pain >3 out of 10 on the visual analog scale (VAS)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Life University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed Qazi

Role: PRINCIPAL_INVESTIGATOR

Life University

Locations

Dr. Sid E. Williams Center for Chiropractic Research

Marietta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daekiara Smith-Ireland, MPH

Role: CONTACT

research.studies@life.edu

7704262639

Facility Contacts

Daekiara Smith-Ireland, MPH

Role: primary

research.studies@life.edu

770-426-2639

Other Identifiers

I-0025

Identifier Type: -

Identifier Source: org_study_id