PainNCT04542707
Brainwave Activity Response on Common Physical Therapy Intervention
A study testing joint manipulation, Exercise and Soft tissue massage in people with Pain, run by Florida Gulf Coast University at 1 site in United States.
Trial summary
This study is designed to evaluate the if there is a predictable patterns in brainwave activity and to see how this changes with external physical therapy interventions such as manipulation, soft tissue massage, and exercise. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- joint manipulation, Exercise and Soft tissue massage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to 1 Jul 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be between the ages of 18-60.
- The subjects for the manipulation group should have no history of thoracic spine pain in the last 6 months, no thoracic spine injuries within the past 6 months.
- The subjects for the exercise groups should be novice exercisers that do not workout often and can tolerate a 15 minute moderate intensity exercises.
Who cannot join
- A history of concussion, traumatic brain injury, stroke, or any known central nervous system disorder TBI, or brain damage.
- The specific exclusion criteria are for the manipulation group is osteopenia/osteoporosis or any other conditions or medications that would lead to skeletal compromise.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Gulf Coast University
Fort Myers, Florida, 33965
About this study
This study is designed to evaluate the if there is a predictable patterns in brainwave activity and to see how this changes with external physical therapy interventions such as manipulation, soft tissue massage, and exercise.
Read the detailed description
This study is designed to evaluate the how the brain responds to external stimulation. Patients with chronic pain can benefit from physical therapy treatments, such as manipulation, soft tissue massage, and exercise. This study is made up of three different phases.
In the first phase to objective is to identify if there is a typical resting brain wave activity (measured with EEG) in asymptomatic subjects. In the second phase of the project the subjects will undergo physical therapy interventions and the brain wave response will be measured. The interventions are chosen based on the fact that they have been demonstrated in the literature to decrease pain.
Joint manipulation is a manual therapy intervention used with patients that experience pain and decreased range of motion. When undergoing a manipulation, audible sounds often occurring with the manipulation and sometimes this does not occur. In the current literature there is a difference between the effects of spinal manipulation and manipulation of the joints in the extremities. For that reason, this study will evaluate the response in both. It is not clear in the current literature if the audible sound has a true therapeutic effect. It is possible that patient perception of this sound will create a specific brainwave response pattern. This might support the clinician's pursuit of the audible sound.
Exercise has been shown to decrease pain, stiffness and increase ROM. Overall exercise contributes to wellbeing. There are different types of exercise such as strength exercise, aerobic exercise (aiming at increasing your heart rate) and body/ mind exercises (Yoga). In this phase of the study brainwave response on each of these types of exercises will be evaluated.
Soft tissue massage is a modality that has been shown to increase blood flow and decrease pain. This change in pain perception should lead to an altered brain wave activity.
As part of the phase the brain wave response on joint manipulation, exercise, and soft tissue massage on asymptomatic subjects will be measured and compared to each other. The hypothesis is that there will be a predictable pattern of brain response in each intervention.
The third phase of this study is to repeat the measures and intervention in subjects that experience pain. The hypothesis is that there is an altered brainwave response compared to the asymptomatic group. Additionally, in this phase the investigators will measure the brainwave response of FGCU college athletes who sprained their ankle within three days of the injury.
- Conditions
- Pain
- Being tested
- joint manipulation, Exercise, Soft tissue massage
- Keywords
- Brain wave activity, Exercise, Joint manipulation, Soft tissue massage, Pupillometry
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
joint manipulationProcedure or surgery
Thrust manipulation to the spine, hand, and foot
ExerciseProcedure or surgery
Strength training, bike aerobic training, and yoga exercise
Soft tissue massageDevice
Graston tool
| Study group | Role | What they receive |
|---|---|---|
| Joint manipulation | Experimental | Grade V-Thrust manipulation with audible sound and without audible sounds of C1-C2, T7, MTP 2 and MCP2 joints. Receives: Procedure: joint manipulation |
| Exercise | Experimental | Aerobic, anaerobic, and yoga exercises Receives: Procedure: Exercise |
| Soft tissue massage | Experimental | Instrument assisted soft tissue massage Receives: Device: Soft tissue massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain wave activity
EEG power in alpha, beta, delta, and gamma bands
Measured: 1 hour
Pupilometry
ANS response by measuring pupil diameter with automatic device
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start20 Aug 2020
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This experiment will be cross sectional study. Convenience sampling technique asymptomatic healthy subjects
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 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
- Investigators
- Rob Sillevis, Principal investigator, FGCU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542707
- Sponsor's protocol ID
- 2020-64
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2020
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Not sure at his time
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brainwave Activity Response on Common Physical Therapy Intervention
- ClinicalTrials.gov ID
- NCT04542707
- Acronym / sponsor ID
- 2020-64
- Conditions
- Pain
- Keywords
- Brain wave activity, Exercise, Joint manipulation, Soft tissue massage, Pupillometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 9 Sep 2020 (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.
This study is designed to evaluate the if there is a predictable patterns in brainwave activity and to see how this changes with external physical therapy interventions such as manipulation, soft tissue massage, and exercise.
Detailed description
This study is designed to evaluate the how the brain responds to external stimulation. Patients with chronic pain can benefit from physical therapy treatments, such as manipulation, soft tissue massage, and exercise. This study is made up of three different phases.
In the first phase to objective is to identify if there is a typical resting brain wave activity (measured with EEG) in asymptomatic subjects. In the second phase of the project the subjects will undergo physical therapy interventions and the brain wave response will be measured. The interventions are chosen based on the fact that they have been demonstrated in the literature to decrease pain.
Joint manipulation is a manual therapy intervention used with patients that experience pain and decreased range of motion. When undergoing a manipulation, audible sounds often occurring with the manipulation and sometimes this does not occur. In the current literature there is a difference between the effects of spinal manipulation and manipulation of the joints in the extremities. For that reason, this study will evaluate the response in both. It is not clear in the current literature if the audible sound has a true therapeutic effect. It is possible that patient perception of this sound will create a specific brainwave response pattern. This might support the clinician's pursuit of the audible sound.
Exercise has been shown to decrease pain, stiffness and increase ROM. Overall exercise contributes to wellbeing. There are different types of exercise such as strength exercise, aerobic exercise (aiming at increasing your heart rate) and body/ mind exercises (Yoga). In this phase of the study brainwave response on each of these types of exercises will be evaluated.
Soft tissue massage is a modality that has been shown to increase blood flow and decrease pain. This change in pain perception should lead to an altered brain wave activity.
As part of the phase the brain wave response on joint manipulation, exercise, and soft tissue massage on asymptomatic subjects will be measured and compared to each other. The hypothesis is that there will be a predictable pattern of brain response in each intervention.
The third phase of this study is to repeat the measures and intervention in subjects that experience pain. The hypothesis is that there is an altered brainwave response compared to the asymptomatic group. Additionally, in this phase the investigators will measure the brainwave response of FGCU college athletes who sprained their ankle within three days of the injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This experiment will be cross sectional study. Convenience sampling technique asymptomatic healthy subjects
| Arm | Type | Receives |
|---|---|---|
| Joint manipulation | Experimental | Procedure: joint manipulationGrade V-Thrust manipulation with audible sound and without audible sounds of C1-C2, T7, MTP 2 and MCP2 joints. |
| Exercise | Experimental | Procedure: ExerciseAerobic, anaerobic, and yoga exercises |
| Soft tissue massage | Experimental | Device: Soft tissue massageInstrument assisted soft tissue massage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will be between the ages of 18-60.
- The subjects for the manipulation group should have no history of thoracic spine pain in the last 6 months, no thoracic spine injuries within the past 6 months.
- The subjects for the exercise groups should be novice exercisers that do not workout often and can tolerate a 15 minute moderate intensity exercises.
Key exclusion criteria (2 listed)
- A history of concussion, traumatic brain injury, stroke, or any known central nervous system disorder TBI, or brain damage.
- The specific exclusion criteria are for the manipulation group is osteopenia/osteoporosis or any other conditions or medications that would lead to skeletal compromise.
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 |
|---|---|---|
| joint manipulationThrust manipulation to the spine, hand, and foot | Procedure or surgery | Joint manipulation |
| ExerciseStrength training, bike aerobic training, and yoga exercise | Procedure or surgery | Exercise |
| Soft tissue massageGraston tool | Device | Soft tissue massage |
Primary outcome
Brain wave activity
Time frame: 1 hour
EEG power in alpha, beta, delta, and gamma bands
Pupilometry
Time frame: 5 minutes
ANS response by measuring pupil diameter with automatic device
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 7 Aug 2025.
- Individual participant dataSharing planned: Undecided. Not sure at his time
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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.
Rob Sillevis principal investigator
FGCU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing joint manipulation, Exercise and Soft tissue massage in people with Pain, 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 3 inclusion and 2 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 7 Aug 2025. 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?
Brain wave activity (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 7 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.