A Feasibility and Pilot Study of an MRI Study to Investigate Changes After Osteopathic Manipulation Therapy in Patients With Myofascial Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- MRI Biomarkers - Structural MRI
研究概览
简要总结
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
详细描述
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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
MRI Biomarkers - Structural MRI
时间窗: 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.
fMRI
时间窗: 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.
MRI Biomarkers - Diffusion Tensor MRI (DTI)
时间窗: 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.
次要结局
- 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.)
- Six Minute Walk Test(Outcome will be assessed at Time 1 within the 4 hour duration.)
- Pain Catastrophizing Scale (Pain Catastrophizing Scale - Short Form 6 item version)(Outcome will be assessed at Time 1 within the 4 hour duration.)
- Sleep Scale (PROMIS Sleep Disturbance 6a+ Sleep Duration Question)(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.)
- Pain Intensity Scale (PEG)(Outcome will be assessed at Time 1 within the 4 hour duration.)
- Pain Interference Scale (PEG)(Outcome will be assessed at Time 1 within the 4 hour duration.)
- 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.)
- Neck Disability Index (NDI)(Outcome will be assessed at Time 1 within the 4 hour duration.)
- Get up and Go Test (GUG)(Outcome will be assessed at Time 1 within the 4 hour duration.)
- Physical Function/Quality of Life Scale (PROMIS Physical Functioning Short Form 6B)(Outcome will be assessed at Time 1 within the 4 hour duration.)
- Anxiety Scale(GAD-7)(Outcome will be assessed at Time 1 within the 4 hour duration.)
- Global Satisfaction with Treatment Scale (PGIC)(Outcome will be assessed at Time 1 within the 4 hour duration.)
- Depression Scale (PHQ-9)(Outcome will be assessed at Time 1 within the 4 hour duration.)
- Substance Abuse Screener (TAPS1)(Outcome will be assessed at Time 1 within the 4 hour duration.)
- Medication Intake Form(Outcome will be assessed at Time 1 within the 4 hour duration.)
研究者
Pao-Feng Tsai
Professor & Associate Dean for Research
Auburn University