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| ID | Type | Description | Link |
|---|---|---|---|
| INTERSHIELD 26-002257 | Other Grant/Funding Number | Mayo Clinic Radiology |
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The purpose of this study is to quantify Magnetic Resonance Elastography (MRE)-derived mechanical property biomarkers of the lumbar paraspinal musculature and associated myofascial tissue regions before and after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expert Manipulative Massage Automation (EMMA) | Experimental | Subjects will receive one massage therapy session utilizing the EMMA system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMMA (Expert Manipulative Massage Automation) | Device | Participants will receive device-assisted massage therapy using EMMA (Expert Manipulative Massage Automation). Each treatment session will last approximately 30 minutes. The device will be operated using conservative settings with predefined maximum force and pressure limits. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SII-derived mobility index | Baseline, 30 minutes post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain, Enjoyment of Life, and General Activity (PEG) Scale Score | The Pain, Enjoyment of Life, and General Activity (PEG) scale is a 3-item participant-reported measure used to assess pain intensity and pain-related interference with enjoyment of life and general activity. The total PEG score is calculated as the average of the 3 item scores and ranges from 0 to 10, with higher scores indicating greater pain severity and interference. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Bush | Contact | 507-266-1008 | Bush.Melissa1@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ziying Yin, Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Baseline, 30 minutes post-intervention |
| Change in Spinal Range of Motion (ROM) | Spinal range of motion will be assessed by a clinical assessor using a bubble inclinometer. Measurements will include lumbar flexion and right and left lateral bending. The outcome will be reported as the change from baseline in spinal range of motion, measured in degrees. | Baseline, 30 minutes post-intervention |
| D013568 |
| Pathological Conditions, Signs and Symptoms |