Myofascial Pain SyndromeNCT06538727
Pilot MRI Study on Osteopathic Manipulation for Myofascial Pain Syndrome
A study testing Osteopathic Manipulation Treatment - Scapular Release in people with Myofascial Pain Syndrome, run by Auburn University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Osteopathic Manipulation Treatment - Scapular Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Feasibility and Pilot Study of an MRI Study to Investigate Changes After Osteopathic Manipulation Therapy in Patients With Myofascial Pain Syndrome
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.
Read more
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
Read the 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:
- 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:
- 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
- Being tested
- Osteopathic Manipulation Treatment - Scapular Release
- Keywords
- Myofascial Pain, MPS, Myofascial Pain Syndrome, Myofascial Trigger Point
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulation Treatment - Scapular ReleaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Osteopathic Manipulation Treatment - Scapular Release |
| Group 2 - No intervention | No intervention | Participants in the control condition will receive no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Measured: 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
Measured: Outcome will be assessed at Time 1 within the 4 hour duration.
Sit to Stand Test (STS)
Objective physical function measure
Measured: Outcome will be assessed at Time 1 within the 4 hour duration.
Get up and Go Test (GUG)
Objective physical function measure
Measured: Outcome will be assessed at Time 1 within the 4 hour duration.
Six Minute Walk Test
Objective physical function measure
Measured: Outcome will be assessed at Time 1 within the 4 hour duration.
Pain Intensity Scale (PEG)
Self-report survey-Pain
Measured: Outcome will be assessed at Time 1 within the 4 hour duration.
Pain Interference Scale (PEG)
Self-report survey-Pain
Measured: 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
Measured: 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
Measured: 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
Measured: Outcome will be assessed at Time 1 within the 4 hour duration.
Depression Scale (PHQ-9)
Self-report survey-Depression
Measured: Outcome will be assessed at Time 1 within the 4 hour duration.
Anxiety Scale(GAD-7)
Self-report survey-Anxiety
Measured: Outcome will be assessed at Time 1 within the 4 hour duration.
Global Satisfaction with Treatment Scale (PGIC)
Self-report survey-Global satisfaction
Measured: Outcome will be assessed at Time 1 within the 4 hour duration.
Substance Abuse Screener (TAPS1)
Self-report survey-Substance abuse
Measured: Outcome will be assessed at Time 1 within the 4 hour duration.
Medication Intake Form
Self-report survey-Medication intake
Measured: Outcome will be assessed at Time 1 within the 4 hour duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start31 Aug 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Edward Via College of Osteopathic Medicine-Auburn
- Responsible party
- Principal investigator, Pao-Feng Tsai, Auburn University
- Investigators
- Pao-Feng Tsai, PhD, Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538727
- Sponsor's protocol ID
- MPS2024
- Status last verified
- Jul 2024
- First submitted
- 29 May 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Pilot Study of an MRI Study to Investigate Changes After Osteopathic Manipulation Therapy in Patients With Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06538727
- Acronym / sponsor ID
- MPS2024
- Conditions
- Myofascial Pain Syndrome
- Keywords
- Myofascial Pain, MPS, Myofascial Pain Syndrome, Myofascial Trigger Point
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Edward Via College of Osteopathic Medicine-Auburn
- Study start
- 31 Aug 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 - One session of OMT Intervention | Experimental | Other: Osteopathic Manipulation Treatment - Scapular ReleaseParticipants in the experimental condition will have one OMT treatment (Scapular Release) done to the upper back. |
| Group 2 - No intervention | No intervention | –Participants in the control condition will receive no treatment. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulation Treatment - Scapular ReleaseFirst, 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. | Other | Group 1 - One session of OMT Intervention |
Primary outcome
MRI Biomarkers - Structural MRI
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.
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.
MRI Biomarkers - Diffusion Tensor MRI (DTI)
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.
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.
fMRI
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.
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.
17 secondary outcomes
Pressure pain threshold (PPT) Assessment
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.
Active Range of Motion (AROM) Assessment
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.
Verbal Pain Report (VAS) Measure
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.
Neck Disability Index (NDI)
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Sit to Stand Test (STS)
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Get up and Go Test (GUG)
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Six Minute Walk Test
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Pain Intensity Scale (PEG)
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Pain Interference Scale (PEG)
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Physical Function/Quality of Life Scale (PROMIS Physical Functioning Short Form 6B)
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Sleep Scale (PROMIS Sleep Disturbance 6a+ Sleep Duration Question)
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Pain Catastrophizing Scale (Pain Catastrophizing Scale - Short Form 6 item version)
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Depression Scale (PHQ-9)
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Anxiety Scale(GAD-7)
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Global Satisfaction with Treatment Scale (PGIC)
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Substance Abuse Screener (TAPS1)
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Medication Intake Form
Time frame: Outcome will be assessed at Time 1 within the 4 hour duration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pao-Feng Tsai, PhD principal investigator
Auburn University
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulation Treatment - Scapular Release in people with Myofascial Pain Syndrome, run by Auburn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pao-Feng Tsai, PhD (334-844-6807, pzt0022@auburn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Biomarkers - Structural MRI (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.