Chronic PainNCT04908670
Comparison of the Effect of Spine Grade I and II Manipulation and a PNE Video on Brainwaves: Pilot Study
A study testing Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI and PA manipulation in people with Chronic Pain and Manipulation, run by Florida Gulf Coast University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Manipulation, Psychologic
- What is being tested?
- Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI and PA manipulation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrated therapy Practice PC
Merrillville, Indiana, 46410
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Manipulation, Psychologic
- Being tested
- Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI, PA manipulation
- Keywords
- Pain neuroscience education, EEG, Spinal manipulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvIBehavioural
Watching pain neuroscience education video
PA manipulationProcedure or surgery
Low grade PA manipulation on the cervical, thoracic and lumbar spine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG power in alpha, delta, gamma, and theta waves
alpha, delta, gamma, and theta waves brain wave measures
Measured: 4- 10 seconds measures of all wave bands in one session measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start29 Jun 2020
- Primary completion2 Aug 2020
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rob Sillevis,, Florida Gulf Coast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908670
- Sponsor's protocol ID
- 2020-30
- Status last verified
- Jul 2022
- First submitted
- 6 May 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04908670
- Acronym / sponsor ID
- 2020-30
- Conditions
- Chronic Pain, Manipulation, Psychologic
- Keywords
- Pain neuroscience education, EEG, Spinal manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 2 Aug 2020 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| PNE group | Active comparator | Behavioral: Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI, Procedure: PA manipulation5 minute video :Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI. |
| Manipulation group | Active comparator | Behavioral: Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI, Procedure: PA manipulationPA grade I-II oscillation on C7, T4 and L4 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvIWatching pain neuroscience education video | Behavioural | Manipulation group, PNE group |
| PA manipulationLow grade PA manipulation on the cervical, thoracic and lumbar spine | Procedure or surgery | Manipulation group, PNE group |
Primary outcome
EEG power in alpha, delta, gamma, and theta waves
Time frame: 4- 10 seconds measures of all wave bands in one session measures
alpha, delta, gamma, and theta waves brain wave measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI and PA manipulation in people with Chronic Pain and Manipulation, run by Florida Gulf Coast University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG power in alpha, delta, gamma, and theta waves (time frame: 4- 10 seconds measures of all wave bands in one session measures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.