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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61AT012279-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| New York University | OTHER |
| George Mason University | OTHER |
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The purpose of this study is to quantify the extent of GlycosAminoGlycan/Hyaluronic Acid (GAG/HA) accumulation using T1rho (T1ρ) MRI in the paretic versus non-paretic shoulder rotator muscles, and correlate the T1ρ Magnetic Resonance Imaging (MRI) measurements with US echo texture measurements to develop a clinic-friendly tool to infer the extent of HA accumulation; and to distinguish between latent versus active Post Stroke Shoulder Pain (PSSP) using ultrasound (US) shear strain mapping of the same muscles on the paretic side compared with the non-paretic side.
Shoulder pain is extremely common after stroke and occurs in 30-70% of patients. Chronic post stroke shoulder pain (PSSP) contributes to depression, interferes with motor recovery, and decreases quality of life. Although PSSP is thought to be caused by damage to the myofascial tissues around the shoulder joint, the pathophysiology of myofascial dysfunction and pain in PSSP has not been elucidated, leading to missed opportunities for early diagnosis, and variable success with pain management. The accumulation of HA in muscle and its fascia can cause myofascial dysfunction. HA is a GAG and a chief constituent of the extracellular matrix of muscle. In physiologic quantities, it functions as a lubricant and a viscoelastic shock absorber, enabling force transmission during muscle contraction and stretch. Reduced joint mobility and spasticity can result in focal accumulation and alteration of HA in muscle, leading to the development of taut bands, dysfunctional gliding of deep fascia and muscle layers, Reduced Range of Motion (ROM), and pain. Muscle HA concentrations can be imaged using T1ρ MRI, and myofascial dysfunction can be assessed using echo texture analysis and shear strain mapping on quantitative US, which may serve as useful biomarkers to elucidate the pathophysiology of myofascial dysfunction in PSSP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paretic | Experimental | Subgroups: Low severity PSSP - defined as focal palpable nodules that may be tender on palpation with pain rating of < 5/10 when combined with the hand-behind-neck (HBN) maneuver. High severity PSSP - defined as focal palpable nodules that are tender on palpation, reproducing the pain, and eliciting a pain rating of >= 5/10 when combined with the hand-behind-neck (HBN) maneuver. |
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| Non-Paretic | Other | The non-paretic side of the same patients serves as the control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaging | Diagnostic Test | Phase 1 is an imaging biomarker study. |
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| Measure | Description | Time Frame |
|---|---|---|
| T1 Rho MRI Relaxation Time of Shoulder External Rotator (Milliseconds) | Comparison of T1rho (T1ρ) MRI relaxation time of infraspinatus muscles on the paretic and non-paretic sides of patients with post stroke shoulder pain. | Baseline |
| T1 Rho MRI Relaxation Time of Shoulder Internal Rotator (Milliseconds) | Comparison of T1rho (T1ρ) MRI relaxation time of pectoralis major muscles on paretic and non-paretic shoulders in patients with post stroke shoulder pain. | Baseline |
| Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Muscles | Comparison of ultrasound shear strain between pectoralis major and pectoralis minor muscles on the paretic and non-paretic sides in patients with post stroke shoulder pain. | Baseline |
| Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Side in Patients With High Severity Post Stroke Shoulder Pain | Comparison of ultrasound shear strain between pectoralis major and minor muscles on the paretic side compared with the non-paretic side in patients with high severity post stroke shoulder pain | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Preeti Raghavan, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
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Of 46 consented participants, 42 met inclusion criteria.
All participants were enrolled at Johns Hopkins Hospital.
| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Post-Stroke | Subjects will undergo testing on their non-paretic arm which will serve as a proxy for "healthy" control. Subjects will undergo 3 types of quantitative imaging of the pectoralis major (key internal rotator) and infraspinatus (key external rotator) muscles of both arms |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
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| Overall Study |
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Total of 46 participants have been consented and 42 met the eligibility criteria. out of 42 participants who finished the study, 7 lacked usable MRI or Ultrasound images and were excluded from the analysis. 35 participants have been included in the final analysis. Out of these 35, 31 have been used for MRI analysis and, 33 have been used for ultrasound analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Paretic - Low Severity | Low severity PSSP defined as focal palpable nodules that may be tender on palpation with pain rating of < 5/10 when combined with the hand-behind-neck (HBN) maneuver. Imaging: Phase 1 is an imaging biomarker study. |
| BG001 | Paretic - High Severity |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | T1 Rho MRI Relaxation Time of Shoulder External Rotator (Milliseconds) | Comparison of T1rho (T1ρ) MRI relaxation time of infraspinatus muscles on the paretic and non-paretic sides of patients with post stroke shoulder pain. | MRI data were collected from 31 participants to compare paretic side with non-paretic side. Four participants were excluded based on pre-specified MRI criteria not being met. Five participants were excluded from analysis based on not meeting pre-specified criteria for pain. | Posted | Mean | Standard Deviation | milliseconds | Baseline | shoulder | shoulder |
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Up to 3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Post-stroke | Subjects will undergo testing on their non-paretic arm which will serve as a proxy for "healthy" control. Subjects will undergo 3 types of quantitative imaging of the pectoralis major (key internal rotator) and infraspinatus (key external rotator) muscles of both arms. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Preeti Raghavan | Johns Hopkins school of medicine | 9174889626 | praghavan@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2023 | May 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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High severity PSSP is defined as focal palpable nodules that are tender on palpation, reproducing the pain, and eliciting a pain rating of >= 5/10 when combined with the hand-behind-neck (HBN) maneuver. Imaging: Phase 1 is an imaging biomarker study. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Time since stroke | Mean | Standard Deviation | Months |
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Healthy side/shoulder.
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| Primary | T1 Rho MRI Relaxation Time of Shoulder Internal Rotator (Milliseconds) | Comparison of T1rho (T1ρ) MRI relaxation time of pectoralis major muscles on paretic and non-paretic shoulders in patients with post stroke shoulder pain. | MRI data was collected from 31 participants to compare paretic side with non-paretic side. Four participants were excluded based on pre-specified MRI criteria not being met. Five participants were excluded from analysis based on not meeting pre-specified criteria for pain. | Posted | Mean | Standard Deviation | milliseconds | Baseline | shoulder | shoulder |
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| Primary | Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Muscles | Comparison of ultrasound shear strain between pectoralis major and pectoralis minor muscles on the paretic and non-paretic sides in patients with post stroke shoulder pain. | Ultrasound data were collected from 33 participants to compare paretic side with non-paretic side. Two were excluded from analysis based on lack of image clarity. Five participants were excluded from analysis based on not meeting pre-specified criteria for pain. | Posted | Mean | Standard Deviation | Shear strain percentage | Baseline | shoulder | shoulder |
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| Primary | Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Side in Patients With High Severity Post Stroke Shoulder Pain | Comparison of ultrasound shear strain between pectoralis major and minor muscles on the paretic side compared with the non-paretic side in patients with high severity post stroke shoulder pain | Ultrasound data were collected from 18/33 participants with high severity PSSP to compare paretic side with non-paretic side. | Posted | Mean | Standard Deviation | Shear strain percentage | Baseline | shoulder | shoulder |
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| 0 |
| 42 |
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| 42 |
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| 42 |
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