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| Name | Class |
|---|---|
| Auburn University MRI Research Center | UNKNOWN |
| Edward Via College of Osteopathic Medicine-Auburn | UNKNOWN |
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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:
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:
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:
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
Physical Function Assessment
1 hour of MRI Scans
Receive OMT Intervention (15-minute scapular release procedure)
1 hour of MRI Scans
Physical Function Assessment
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
Battery of self-report surveys
Clinical/Physical Function Assessment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - One session of OMT Intervention | Experimental | Participants in the experimental condition will have one OMT treatment (Scapular Release) done to the upper back. |
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| Group 2 - No intervention | No Intervention | Participants in the control condition will receive no treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic Manipulation Treatment - Scapular Release | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pao-Feng Tsai, PhD | Contact | 334-844-6807 | pzt0022@auburn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pao-Feng Tsai, PhD | Auburn University | Principal Investigator |
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| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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To achieve both aims, a two-arm-experimental design with a posttest control-group-only, will be conducted in a convenience sample of 20 adult patients with MPS of the upper back. Participants will be randomly allocated to one of the following three groups with a 1:1 ratio:
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| 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. |