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Physical Therapy Techniques for Pain
N/A
Recruiting
Led By Rob Sillevis
Research Sponsored by Florida Gulf Coast University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Must not have
The specific exclusion criteria for the manipulation group is osteopenia/osteoporosis or any other conditions or medications that would lead to skeletal compromise.
A history of concussion, traumatic brain injury, stroke, or any known central nervous system disorder TBI, or brain damage.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at whether there are patterns in brainwave activity that respond to physical therapies like manipulation, massage, and exercise.
Who is the study for?
This trial is for adults aged 18-60 with no thoracic spine pain or injuries in the past 6 months. Participants should either be novice exercisers able to do a moderate workout for 15 minutes, or have healthy bones without conditions like osteoporosis. Those with a history of brain injury or central nervous system disorders cannot join.
What is being tested?
The study aims to observe changes in brainwave activity during physical therapy interventions such as joint manipulation, exercise, and soft tissue massage to identify any predictable patterns.
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort at the site of manipulation or massage, muscle soreness from exercise, and fatigue following treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Select...
I haven't had any upper back pain or injuries in the last 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have weak bones or any condition that affects my skeleton.
Select...
I have a history of brain injury or disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brain wave activity
Pupilometry
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Soft tissue massageExperimental Treatment3 Interventions
Instrument assisted soft tissue massage
Group II: Joint manipulationExperimental Treatment3 Interventions
Grade V-Thrust manipulation with audible sound and without audible sounds of C1-C2, T7, MTP 2 and MCP2 joints.
Group III: ExerciseExperimental Treatment3 Interventions
Aerobic, anaerobic, and yoga exercises
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~820
Find a Location
Who is running the clinical trial?
Florida Gulf Coast UniversityLead Sponsor
13 Previous Clinical Trials
518 Total Patients Enrolled
Rob SillevisPrincipal InvestigatorFGCU
1 Previous Clinical Trials
50 Total Patients Enrolled