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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04908670
Other study ID # 2020-30
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 29, 2020
Est. completion date January 1, 2022

Study information

Verified date July 2022
Source Florida Gulf Coast University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 1, 2022
Est. primary completion date August 2, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Integrated therapy Practice PC Merrillville Indiana

Sponsors (1)

Lead Sponsor Collaborator
Florida Gulf Coast University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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