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

The Effect of Low-grade Spinal Oscillations Compared to a Pain Neuroscience Education Video on Electroencephalogram (EEG) Brain Activity on Individuals With Chronic Spine Pain: Pilot Study. WITH CHRONIC SPINE PAIN: PILOT STUDY

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Manipulation; Psychologic
• Intervention / Treatment: 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

Detailed Description

This quasi-experimental pilot study compared differences in brainwave activity in subjects with chronic spinal pain following PA spinal oscillations and after viewing a 5-minute pain neuroscience educational video.

In this within subject's design all subjects were given the two interventions on two different days. To prevent the order of the intervention to influence the study results the subjects were randomized into two different groups, A and B. Group A received PA spinal oscillations on their first visit and. Group B's underwent the opposite and watched a pain neuroscience education video on their first visit and received PA spinal oscillations on their first visit. Both sessions and interventions were lead and performed by the Doctor of Physical Therapy student under the direct supervision of the lead physical therapist, who is manually trained and holds a Cranio-Facial Certification. In order to standardize the location of the PA spinal oscillation intervention so brain activity and response can be properly compared, C7, T4 and L4 were identified and marked with a pen prior to any measures. Identification of L4 was achieved by placing hands on the subject's iliac crests with thumbs pointing toward one another. Keeping hands straight and parallel to the floor, thumbs will move medially, landing on L4.25 To identify C7, the subject was taken through cervical extension, where C6 will disappear and C7 remains in place.26 Once C7 was located, the spinous processes were palpated and counted until the level of T4, which was marked. Various factors can affect the reliability of this process, such as subject obesity, therapist experience, and anatomical differences.25 Studies show reliability for this method to be low.25,26 However, these studies, as with most, use a small sample size and only using one palpatory landmark for each level examined.25,26 To standardize variables, the methods above were used in conjunction with palpation of surrounding vertebrae. To measure brain wave activity during this study the 14-lead Emotiv EPOC portable EEG headset was used. Each participant wore the headset throughout the measurement and was in a seated position. After the EEG headset was placed properly and connection with the system had been appropriately established the subjects remained seated in a quiet room for three minutes to accommodate to the room environment before the first EEG measurement. After this, a 1-minute EEG recording was taken. This measurement served as the participant's baseline measurement. Group A subjects then received a grade I & II spinal oscillations of three identified segments (C7, T4, and L4), 1 minute per segment for a total of 3 minutes. Directly following this a second 1-minute EEG recording was taken. On the subsequent visit, group A again underwent the three-minute seated accommodation period with the EEG headset on, followed by a 1 minute baseline EEG measurement prior to watching a 5 minute pain neuroscience educational video Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI. A 1-minute EEG recording was taken during the first minute of the video and again during the last minute of the video. Immediately after watching the pain neuroscience educational video a 1-minute EEG recording was taken. The measurement protocol for group B was the same, but in reversed order. They watched the pain neuroscience educational video at their first visit and the PA spinal oscillations on their next visit.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Merrillville, Indiana, United States, 46410
      • Integrated therapy Practice PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects in this study were males and female between the ages of 20 to 65 years with chronic lower back pain (> 3 months). Exclusion Criteria:

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PNE group; 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; Watching pain neuroscience education video; Procedure: PA manipulation; Low grade PA manipulation on the cervical, thoracic and lumbar spine
Active Comparator: Manipulation group; 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; Watching pain neuroscience education video; Procedure: PA manipulation; Low grade PA manipulation on the cervical, thoracic and lumbar spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Florida Gulf Coast University

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): August 2, 2020
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: EEG; Spinal manipulation; Pain neuroscience education
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2020-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No