Pilot MRI Study on Osteopathic Manipulation for Myofascial Pain Syndrome

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorAuburn University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Malignancy.

Major psychiatric disorders, such as bipolar disorder and depression.

Cognitive impairment

Skin lesion(s) on the shoulders and upper back.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Osteopathic Manipulation Treatment - Scapular Release

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Group 1 - One session of OMT InterventionExperimental treatment 1 intervention
Group B: Group 2 - No interventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
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.
2

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.

Time frame
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.
3

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.

Time frame
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 outcomes

1

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.

Time frame
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.
2

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.

Time frame
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.
3

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.

Time frame
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.
4

Neck Disability Index (NDI)

Measure self-report neck disability

Time frame
Outcome will be assessed at Time 1 within the 4 hour duration.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Auburn University

Lead sponsor

Auburn University MRI Research Center

Collaborator

Edward Via College of Osteopathic Medicine-Auburn

Collaborator

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