Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06538727
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-06
First Post:
2024-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot MRI Study on Osteopathic Manipulation for Myofascial Pain Syndrome
Sponsor:
Auburn University
Organization:
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:
False
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
* Clinical/Physical 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
* Clinical/Physical 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 Function/Quality 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 Scale(GAD-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 Function/Quality 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 Scale(GAD-7)
* Global Satisfaction with Treatment Scale (PGIC)
* Substance Abuse Screener (TAPS1).
* Medication Intake Form
* Clinical/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
* 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 Function/Quality 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 Scale(GAD-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 Function/Quality 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 Scale(GAD-7)
* Global Satisfaction with Treatment Scale (PGIC)
* Substance Abuse Screener (TAPS1).
* Medication Intake Form
* Clinical/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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: