Comparison of the Effect of Spine Grade I and II Manipulation and a PNE Video on Brainwaves: Pilot Study

NCT04908670 | Completed

• 1 other identifier: 2020-30
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of the use of a pain neuroscience educational video instruction on brainwave activity and compare this to the effects of a grade I \& II PA spinal oscillations of the spine using EEG in individuals with chronic pain.

Conditions

Chronic Pain; Manipulation; Psychologic

Keywords

Pain neuroscience education; EEG; Spinal manipulation

Outcome Measures

Primary Outcomes (1)

• EEG power in alpha, delta, gamma, and theta waves

  alpha, delta, gamma, and theta waves brain wave measures

  4- 10 seconds measures of all wave bands in one session measures

Study Arms (2)

PNE group

ACTIVE COMPARATOR

5 minute video :Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C\_3phB93rvI.

Behavioral: Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI; Procedure: PA manipulation

Manipulation group

ACTIVE COMPARATOR

PA grade I-II oscillation on C7, T4 and L4

Behavioral: Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI; Procedure: PA manipulation

Interventions

Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI BEHAVIORAL

Watching pain neuroscience education video

Manipulation group; PNE group

PA manipulation PROCEDURE

Low grade PA manipulation on the cervical, thoracic and lumbar spine

Manipulation group; PNE group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• were not meeting the age requirement having pain less than three months having conditions that would be a contraindication for the grade I-II PA spinal oscillations Those with known neurological conditions making EEG measures unreliable.

Sponsors & Collaborators

• Florida Gulf Coast University: lead

Study Sites (1)

Integrated therapy Practice PC

Merrillville, Indiana, 46410, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant and clinician providing the manipulation on the spine were blinded to the EEG measures
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Half of the group was assigned randomly to receive intervention 1 and during the second visit intervention 2. The other half received intervention 2 first followed by intervention 1 on subsequent visit

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: June 1, 2021
• Study Start: June 29, 2020
• Primary Completion: August 2, 2020
• Study Completion: January 1, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)