Pilot MRI Study on Osteopathic Manipulation for Myofascial Pain Syndrome

NCT06538727 | Not Yet Recruiting

• 1 other identifier: MPS2024
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Myofascial Pain Syndrome

Keywords

Myofascial Pain; MPS; Myofascial Pain Syndrome; Myofascial Trigger Point

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• Pressure pain threshold (PPT) Assessment

  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

  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

  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)

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

• Sit to Stand Test (STS)

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

Study Arms (2)

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.

Other: Osteopathic Manipulation Treatment - Scapular Release

Group 2 - No intervention

NO INTERVENTION

Participants in the control condition will receive no treatment.

Interventions

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.

Group 1 - One session of OMT Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Auburn University: lead
• Auburn University MRI Research Center: collaborator
• Edward Via College of Osteopathic Medicine-Auburn: collaborator

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Pao-Feng Tsai, PhD

  Auburn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pao-Feng Tsai, PhD

CONTACT

334-844-6807; pzt0022@auburn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Associate Dean for Research

Model Details: 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: * Group 1: receives one session of OMT * Group 2: control group - does not receive intervention

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: August 6, 2024
• Study Start: August 31, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share