Clinical trial NCT06538727: Pilot MRI Study on Osteopathic Manipulation for Myofascial Pain Syndrome
Official title: A Feasibility and Pilot Study of an MRI Study to Investigate Changes After Osteopathic Manipulation Therapy in Patients With Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: Myofascial Pain
MPS
Myofascial Pain Syndrome
Myofascial Trigger Point
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: Auburn University MRI Research Center
name: Edward Via College of Osteopathic Medicine-Auburn
First posted: 2024-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: DIAGNOSTIC

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

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.

Primary outcomes:
measure: MRI Biomarkers - Structural MRI
timeFrame: 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: MRI Biomarkers - Diffusion Tensor MRI (DTI)
timeFrame: 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: fMRI
timeFrame: 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:
measure: Pressure pain threshold (PPT) Assessment
timeFrame: 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: Active Range of Motion (AROM) Assessment
timeFrame: 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: Verbal Pain Report (VAS) Measure
timeFrame: 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: Neck Disability Index (NDI)
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Sit to Stand Test (STS)
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Get up and Go Test (GUG)
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Six Minute Walk Test
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Pain Intensity Scale (PEG)
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Pain Interference Scale (PEG)
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Physical Function/Quality of Life Scale (PROMIS Physical Functioning Short Form 6B)
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Sleep Scale (PROMIS Sleep Disturbance 6a+ Sleep Duration Question)
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Pain Catastrophizing Scale (Pain Catastrophizing Scale - Short Form 6 item version)
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Depression Scale (PHQ-9)
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Anxiety Scale(GAD-7)
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Global Satisfaction with Treatment Scale (PGIC)
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Substance Abuse Screener (TAPS1)
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
measure: Medication Intake Form
timeFrame: Outcome will be assessed at Time 1 within the 4 hour duration.
Other outcomes:
Locations:
Study officials:
affiliation: Auburn University
name: Pao-Feng Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
References: