NCT06538727

Pilot MRI Study on Osteopathic Manipulation for Myofascial Pain Syndrome

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Auburn University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Myofascial Pain Syndrome

Interventions

Type	Name	Description
OTHER	Osteopathic Manipulation Treatment - Scapular Release	First, the patient will be positioned in the supine position. The physician or trained fellow will then place his/her hands on the medial border of the scapula on the affected side. From the paraspinal fascia to the medial border of the scapula a lateral traction is added along with a superior to inferior traction and additionally an inferior to superior traction. The shoulder will be used as an additional fulcrum by having the shoulder in the forward flexion position at 90 degrees and then adduction of the humerus to aid in addition movement of the scapula by moving the upper arm into adduction and abduction in a rhythmic motion. The treatment with a rhythmic and/or static traction in the motions described above and manual movement of the scapula will be done for a maximum of 15 minutes.

Timeline

• Start date: 2024-08-31
• Primary completion: 2025-04-30
• Completion: 2025-06-30
• First posted: 2024-08-06
• Last updated: 2024-08-06