Pilot MRI Study on Osteopathic Manipulation for Myofascial Pain Syndrome
NCT Number: NCT06538727
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myofascial Pain Syndrome
Interventions: OTHER: Osteopathic Manipulation Treatment - Scapular Release
Sponsor: Auburn University
Collaborators: Auburn University MRI Research Center|Edward Via College of Osteopathic Medicine-Auburn
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-31
Completion Date: 2025-06-30

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

Primary Outcome Measures: MRI Biomarkers - Structural MRI, 3D T1- weighted images (TR (repetition time) = 7 ms, TE (echo time) = 2.4 ms, resolution 0.6 mm3, flip angle = 20°, bandwidth = 790 Hz/pixel) will be used for high-resolution structural imaging. T2 maps will be obtained with T2 prepared gradient-echo (GRE) sequence with centric ordered k- space trajectory. T2 preparation duration will be varied from 24 ms to 84 ms in increments of 10 ms with sequence TR (time between consecutive T2 preps) = 3000 ms. The GRE acquisition parameters will be TR = 7 ms, flip angle = 6° (small flip angle to minimize T1 weighting), and resolution 0.6 mm 3 . T2 and proton density maps will be computed by voxel-wise non-linear fitting to mono-exponential T2 decay., For experimental group (Group 1): Outcomes will be assessed at Time 1 and Time 2 within the 4 hour duration; For no intervention group (Group 2): Outcomes will be assessed at Time 1 within the 4 hour duration.|MRI Biomarkers - Diffusion Tensor MRI (DTI), The DTI will be acquired with a spin echo EPI (echo-planar imaging) sequence, at the same location as anatomical and T2 images, with TE/TR = 55/6000 msec, 2 mm3 isotropic resolution, BW (bandwidth) = 925 Hz/pixel, 12 gradient encoding directions, and b-values of 500 and 800 s/mm2. A Nonlinear least-squares fit will be used to determine the diffusion tensor out of the 12 diffusion weighted images according to the relationship as described before., For experimental group (Group 1): Outcomes will be assessed at Time 1 and Time 2 within the 4 hour duration; For no intervention group (Group 2): Outcomes will be assessed at Time 1 within the 4 hour duration.|fMRI, While all other measurements will be from the myofascial unit or region, fMRI will be acquired from the brain using a 2D gradient-echo multiband EPI (echo-planar imaging) sequence with TR = 1000 ms, TE = 20 ms, flip angle = 70°, voxel dimensions = 2 mm3 , and a multiband factor of 2. After standard pre-processing, brain activity and connectivity in the pain matrix will be assessed., For experimental group (Group 1): Outcomes will be assessed at Time 1 and Time 2 within the 4 hour duration; For no intervention group (Group 2): Outcomes will be assessed at Time 1 within the 4 hour duration.
Secondary Outcome Measures: Pressure pain threshold (PPT) Assessment, A research team member will use an algometer device to measure pressure pain threshold for each MTrP site and a normal tissue site on the opposite side of the upper back. The team member will measure each site for a total of three times, and these three measurements will be averaged for each MTrP site. The algometer will measure in lbs/in2., For experimental group (Group 1): Outcomes will be assessed at Time 1 and Time 2 within the 4 hour duration; For no intervention group (Group 2): Outcomes will be assessed at Time 1 within the 4 hour duration.|Active Range of Motion (AROM) Assessment, A goniometer will be used to measure in degrees, the participant's active range of motion. The neck, shoulder, forearm, and back will all be assessed. A separate range of motion in degrees based on the goniometer will be recorded for each body part., For experimental group (Group 1): Outcomes will be assessed at Time 1 and Time 2 within the 4 hour duration; For no intervention group (Group 2): Outcomes will be assessed at Time 1 within the 4 hour duration.|Verbal Pain Report (VAS) Measure, Participants will rate on a scale of 0-10 (Visual Analog Scale) how much pain they are currently experiencing in their upper back., For experimental group (Group 1): Outcomes will be assessed at Time 1 and Time 2 within the 4 hour duration; For no intervention group (Group 2): Outcomes will be assessed at Time 1 within the 4 hour duration.|Neck Disability Index (NDI), Measure self-report neck disability, Outcome will be assessed at Time 1 within the 4 hour duration.|Sit to Stand Test (STS), Objective physical function measure, Outcome will be assessed at Time 1 within the 4 hour duration.|Get up and Go Test (GUG), Objective physical function measure, Outcome will be assessed at Time 1 within the 4 hour duration.|Six Minute Walk Test, Objective physical function measure, Outcome will be assessed at Time 1 within the 4 hour duration.|Pain Intensity Scale (PEG), Self-report survey-Pain, Outcome will be assessed at Time 1 within the 4 hour duration.|Pain Interference Scale (PEG), Self-report survey-Pain, Outcome will be assessed at Time 1 within the 4 hour duration.|Physical Function/Quality of Life Scale (PROMIS Physical Functioning Short Form 6B), Self-report survey-Physical function, Outcome will be assessed at Time 1 within the 4 hour duration.|Sleep Scale (PROMIS Sleep Disturbance 6a+ Sleep Duration Question), Self-report survey-Sleep, Outcome will be assessed at Time 1 within the 4 hour duration.|Pain Catastrophizing Scale (Pain Catastrophizing Scale - Short Form 6 item version), Self-report survey-Pain catastrophizing, Outcome will be assessed at Time 1 within the 4 hour duration.|Depression Scale (PHQ-9), Self-report survey-Depression, Outcome will be assessed at Time 1 within the 4 hour duration.|Anxiety Scale(GAD-7), Self-report survey-Anxiety, Outcome will be assessed at Time 1 within the 4 hour duration.|Global Satisfaction with Treatment Scale (PGIC), Self-report survey-Global satisfaction, Outcome will be assessed at Time 1 within the 4 hour duration.|Substance Abuse Screener (TAPS1), Self-report survey-Substance abuse, Outcome will be assessed at Time 1 within the 4 hour duration.|Medication Intake Form, Self-report survey-Medication intake, Outcome will be assessed at Time 1 within the 4 hour duration.