Status:
RECRUITING
Post-concussion Syndrome and Chiropractic
Lead Sponsor:
Life University
Conditions:
Post-Concussion Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 indiv...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06151184
Start Date
January 27 2024
End Date
July 31 2026
Last Update
February 12 2025
Active Locations (1)
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1
Dr. Sid E. Williams Center for Chiropractic Research
Marietta, Georgia, United States, 30067