Effects of Chiropractic Adjustments on Brain Function Using Quantitative Encephalography

NCT01953614 | Completed

• 1 other identifier: I-0010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the abundance of theories concerning the effects of chiropractic adjustments on brain function, this remains an understudies area for the profession. Quantitative Electroencephalography (qEEG)is a technique that allows for an in-depth analysis of brain function. A normative database will be used to compare before, during and after effects of chiropractic adjustments on brain function. This will include usage of Low Resolution Electromagnetic Tomography (LORETA). This study seeks to objectively document effects of chiropractic adjustments on brain function.

Conditions

Brain Function

Keywords

quantitative encephalography; brain computer interface; chiropractic; sacro-occipital technique

Outcome Measures

Primary Outcomes (1)

• Changes in quantitative EEG values as compared to a normative database

  There will be a baseline measurement. There will be measurements during the adjustment. There will be measurements immediately after the adjustment. There will be measurements 7 days after the adjustment. Data will then be analyzed comparing values to a normative database. This database is adjusted for age. This will generate z-score values in addition to raw EEG values. Statistical analysis of P-values will then be run to test significance of changes.

  Baseline, during adjustment, after adjustment, follow up in 7 days

Secondary Outcomes (1)

• Behavioral assessment questionaire

  At baseline, one week after adjustment.

Study Arms (3)

Placebo group

SHAM COMPARATOR

Ten people. Participants will receive what appears to be a chiropractic adjustment but which actually is not. This is the sham adjustment. Participants will also fill out Achenbach questionnaire. There will be a follow up in 7 days.

Other: Sham adjustment

Chiropractic adjustment

ACTIVE COMPARATOR

Ten people. Group will be getting chiropractic adjustments. Participants will be filling out Achenbach questionnaire. There will be a follow up in 7 days.

Other: Chiropractic adjustment

Control group

NO INTERVENTION

Ten people. This group will simply have their EEG recorded at baseline and after 7 days. There will be an Achenbach questionnaire like the two other groups.

Interventions

Chiropractic adjustment OTHER

Chiropractic adjustment

Sham adjustment OTHER

Placebo group

Eligibility Criteria

• Age: 10 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to receive chiropractic adjustments

You may not qualify if:

• No benzodiazepine class drugs in study participants
• No use of medicines such as Sudafed (pseudoephedrine) or Nyquil (Doxylamine succinate)
• At least 30 days since last chiropractic adjustment

Sponsors & Collaborators

• Life University: lead

Study Sites (1)

Life University

Marietta, Georgia, 30060, United States

Location

MeSH Terms

Interventions

Manipulation, Chiropractic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: October 1, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

US (1)