Pilot MRI Study on Osteopathic Manipulation for Myofascial Pain Syndrome

Auburn University

Status

Not yet enrolling

Conditions

Myofascial Pain Syndrome

Treatments

Other: Osteopathic Manipulation Treatment - Scapular Release

Study type

Interventional

Funder types

Other

Identifiers

NCT06538727

MPS2024

Details and patient eligibility

About

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

Full 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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

MPS of the upper back with MTrPs as specified by Travell and Simons, with the confirmation of ultrasound procedure.
Normal neurological examination including manual muscle testing, sensory exam, and deep tendon reflexes.
English-speaking.
Age 18 - 64 and reside in the community.

Exclusion criteria

Malignancy.
Major psychiatric disorders, such as bipolar disorder and depression.
Cognitive impairment
Skin lesion(s) on the shoulders and upper back.
Systematic pain condition, such as Fibromyalgia.
Previous surgical procedures in the spine, shoulder, and/or back within six months.
Pregnancy.
BMI of 40 or higher.
Any health conditions that prevent participants from performing the experimental procedure
Any contraindications of MRI procedure such as implantable cardiac devices (pacemakers, defibrillator, etc.), aneurysm clips, or metallic shoulder and/or spinal cord implants or screws.