Pilot MRI Study on Osteopathic Manipulation for Myofascial Pain Syndrome

NCT ID: NCT06538727

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-06-30

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group 1 - One session of OMT Intervention

Participants in the experimental condition will have one OMT treatment (Scapular Release) done to the upper back.

Group Type: EXPERIMENTAL

Osteopathic Manipulation Treatment - Scapular Release

Intervention Type: 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 2 - No intervention

Participants in the control condition will receive no treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Auburn University MRI Research Center

UNKNOWN

Sponsor Role: collaborator

Edward Via College of Osteopathic Medicine-Auburn

UNKNOWN

Sponsor Role: collaborator

Auburn University

OTHER

Sponsor Role: lead

Responsible Party

Pao-Feng Tsai

Professor & Associate Dean for Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pao-Feng Tsai, PhD

Role: PRINCIPAL_INVESTIGATOR

Auburn University

Central Contacts

Pao-Feng Tsai, PhD

Role: CONTACT

pzt0022@auburn.edu

334-844-6807

Other Identifiers

MPS2024

Identifier Type: -

Identifier Source: org_study_id