Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538727
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-29
Brief Title:
Pilot MRI Study on Osteopathic Manipulation for Myofascial Pain Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Feasibility and Pilot Study of an MRI Study to Investigate Changes After Osteopathic Manipulation Therapy in Patients With Myofascial Pain Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to conduct MRI studies on adults with myofascial pain syndrome MPS to identify important MRI biomarkers that respond to OMT osteopathic manipulation therapy and investigate the feasibility of implementing MRI study and OMT in this population The main outcomes of the study include
Determine whether biomarkers measured by MRI can differentiate normal tissues and MTrP myofascial trigger point
Test the responsiveness of the biomarkers identified by MRI to the proposed intervention OMT in patients with MPS of the upper back
Researchers will compare participants who will receive one session of OMT Group 1 - Experimental Condition and participants who will not receive any treatment Group 2 - Control Condition to see how the MRI-identified biomarkers respond to the intervention
Participants will complete the following
Clinical screening
MRI measures
Battery of self-report surveys
ClinicalPhysical Function Assessment
Determine whether biomarkers measured by MRI can differentiate normal tissues and MTrP myofascial trigger point
Test the responsiveness of the biomarkers identified by MRI to the proposed intervention OMT in patients with MPS of the upper back
Researchers will compare participants who will receive one session of OMT Group 1 - Experimental Condition and participants who will not receive any treatment Group 2 - Control Condition to see how the MRI-identified biomarkers respond to the intervention
Participants will complete the following
Clinical screening
MRI measures
Battery of self-report surveys
ClinicalPhysical Function Assessment
Detailed Description:
The goal of this clinical trial is to conduct MRI studies on adults with myofascial pain syndrome MPS to identify important MRI biomarkers that respond to OMT and investigate the feasibility of implementing MRI studies and OMT in this population The main outcomes of the study include
Determine whether biomarkers measured by MRI can differentiate normal tissues and MTrP
Test the responsiveness of the biomarkers identified by MRI to the proposed intervention OMT in patients with MPS of the upper back
Researchers will compare participants who will receive one session of OMT Group 1 - Experimental Condition and participants who will not receive any treatment Group 2 - Control Condition to see how the MRI identified biomarkers respond to the intervention
Participants will complete the following tasks in the order below depending on their group assignment
Experimental Group Receives OMT Intervention
MRI pre-screening
Clinical Screening
o Clinical assessment for identifying normal and MTrP tissues by a physician via palpation and verified by ultrasound imaging
Battery of self-report surveys
Pain Intensity Scale PEG
Pain Interference Scale PEG
Physical FunctionQuality of Life Scale PROMIS Physical Functioning Short Form 6B
Sleep Scale PROMIS Sleep Disturbance 6a Sleep Duration Question
Pain Catastrophizing Scale Pain Catastrophizing Scale - Short Form 6 item version
Depression Scale PHQ-9
Anxiety ScaleGAD-7
Global Satisfaction with Treatment Scale PGIC
Substance Abuse Screener TAPS1
Medication Intake Form
Physical Function Assessment
Pain-Pressure Threshold measure PPT
Active Range of Motion measure AROM
Visual Analog Scale VAS
Neck Disability Index NDI
Sit to Stand Test STS
Get up and Go Test GUG
Six Minute Walk Test
1 hour of MRI Scans
Structural MRI
Diffusion Tensor MRI
fMRI functional magnetic resonance imaging
Receive OMT Intervention 15-minute scapular release procedure
1 hour of MRI Scans
Structural MRI
Diffusion Tensor MRI
fMRI
Physical Function Assessment
Pain-Pressure Threshold measure PPT
Active Range of Motion measure AROM
Visual Analog Scale VAS
Control Group No Intervention
MRI pre-screening
Clinical Screening
o Clinical assessment for identifying normal and MTrP tissues by a physician via palpation and verified by ultrasound imaging
1 hour of MRI Scans
Structural MRI
Diffusion Tensor MRI
fMRI
Battery of self-report surveys
Pain Intensity Scale PEG
Pain Interference Scale PEG
Physical FunctionQuality of Life Scale PROMIS Physical Functioning Short Form 6B
Sleep Scale PROMIS Sleep Disturbance 6a Sleep Duration Question
Pain Catastrophizing Scale Pain Catastrophizing Scale - Short Form 6 item version
Depression Scale PHQ-9
Anxiety ScaleGAD-7
Global Satisfaction with Treatment Scale PGIC
Substance Abuse Screener TAPS1
Medication Intake Form
ClinicalPhysical Function Assessment
Pain-Pressure Threshold measure PPT
Active Range of Motion measure AROM
Visual Analog Scale VAS
Neck Disability Index NDI
Sit to Stand Test STS
Get up and Go Test GUG
Six Minute Walk Test
Determine whether biomarkers measured by MRI can differentiate normal tissues and MTrP
Test the responsiveness of the biomarkers identified by MRI to the proposed intervention OMT in patients with MPS of the upper back
Researchers will compare participants who will receive one session of OMT Group 1 - Experimental Condition and participants who will not receive any treatment Group 2 - Control Condition to see how the MRI identified biomarkers respond to the intervention
Participants will complete the following tasks in the order below depending on their group assignment
Experimental Group Receives OMT Intervention
MRI pre-screening
Clinical Screening
o Clinical assessment for identifying normal and MTrP tissues by a physician via palpation and verified by ultrasound imaging
Battery of self-report surveys
Pain Intensity Scale PEG
Pain Interference Scale PEG
Physical FunctionQuality of Life Scale PROMIS Physical Functioning Short Form 6B
Sleep Scale PROMIS Sleep Disturbance 6a Sleep Duration Question
Pain Catastrophizing Scale Pain Catastrophizing Scale - Short Form 6 item version
Depression Scale PHQ-9
Anxiety ScaleGAD-7
Global Satisfaction with Treatment Scale PGIC
Substance Abuse Screener TAPS1
Medication Intake Form
Physical Function Assessment
Pain-Pressure Threshold measure PPT
Active Range of Motion measure AROM
Visual Analog Scale VAS
Neck Disability Index NDI
Sit to Stand Test STS
Get up and Go Test GUG
Six Minute Walk Test
1 hour of MRI Scans
Structural MRI
Diffusion Tensor MRI
fMRI functional magnetic resonance imaging
Receive OMT Intervention 15-minute scapular release procedure
1 hour of MRI Scans
Structural MRI
Diffusion Tensor MRI
fMRI
Physical Function Assessment
Pain-Pressure Threshold measure PPT
Active Range of Motion measure AROM
Visual Analog Scale VAS
Control Group No Intervention
MRI pre-screening
Clinical Screening
o Clinical assessment for identifying normal and MTrP tissues by a physician via palpation and verified by ultrasound imaging
1 hour of MRI Scans
Structural MRI
Diffusion Tensor MRI
fMRI
Battery of self-report surveys
Pain Intensity Scale PEG
Pain Interference Scale PEG
Physical FunctionQuality of Life Scale PROMIS Physical Functioning Short Form 6B
Sleep Scale PROMIS Sleep Disturbance 6a Sleep Duration Question
Pain Catastrophizing Scale Pain Catastrophizing Scale - Short Form 6 item version
Depression Scale PHQ-9
Anxiety ScaleGAD-7
Global Satisfaction with Treatment Scale PGIC
Substance Abuse Screener TAPS1
Medication Intake Form
ClinicalPhysical Function Assessment
Pain-Pressure Threshold measure PPT
Active Range of Motion measure AROM
Visual Analog Scale VAS
Neck Disability Index NDI
Sit to Stand Test STS
Get up and Go Test GUG
Six Minute Walk Test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None