Brainwave Activity Response on Common Physical Therapy Intervention

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: joint manipulation; Procedure: Exercise; Device: Soft tissue massage

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33965
      • Florida Gulf Coast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Joint manipulation; Grade V-Thrust manipulation with audible sound and without audible sounds of C1-C2, T7, MTP 2 and MCP2 joints.	Procedure: joint manipulation; Thrust manipulation to the spine, hand, and foot
Experimental: Exercise; Aerobic, anaerobic, and yoga exercises	Procedure: Exercise; Strength training, bike aerobic training, and yoga exercise
Experimental: Soft tissue massage; Instrument assisted soft tissue massage	Device: Soft tissue massage; Graston tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain wave activity	EEG power in alpha, beta, delta, and gamma bands	1 hour
Pupilometry	ANS response by measuring pupil diameter with automatic device	5 minutes

Collaborators and Investigators

• Sponsor: Florida Gulf Coast University
• Investigators: Principal Investigator: Rob Sillevis, FGCU

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Pupillometry; Brain wave activity; Joint manipulation; Soft tissue massage
• Other Study ID Numbers: 2020-64

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not sure at his time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No