Myofascial Dysfunction
Conditions
Keywords
Glycosaminoglycan, Hyaluronic acid, Post stroke shoulder pain
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTImaging
Phase 1 is an imaging biomarker study.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
New York University
George Mason University
Johns Hopkins University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Hemiparesis from Ischemic or Hemorrhagic Stroke * 4-120 months post-stroke with Hemiparesis since the incidence and intensity of PSSP * Show a difference of more than 10 degrees of passive ER-ROM between non-paretic and paretic shoulders with or without pain * Able to provide informed consent and comply with testing protocols
Exclusion criteria
* Received treatment for spasticity with Botulinum Toxin or Intrathecal Baclofen within the past three months * Have another neurologic condition that may affect motor response (e.g. Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS)) * Have a contraindication to MRI (claustrophobia, magnetic pacemakers and clips) * Have non-musculoskeletal PSSP such as only central pain or Chronic Regional Pain Syndrome (CRPS) * Have a complicated medical condition, or significant injury to either upper limb.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Muscles | Baseline | 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. |
| T1 Rho MRI Relaxation Time of Shoulder External Rotator (Milliseconds) | Baseline | Comparison of T1rho (T1ρ) MRI relaxation time of infraspinatus muscles on the paretic and non-paretic sides of patients with post stroke shoulder pain. |
| T1 Rho MRI Relaxation Time of Shoulder Internal Rotator (Milliseconds) | Baseline | Comparison of T1rho (T1ρ) MRI relaxation time of pectoralis major muscles on paretic and non-paretic shoulders in patients with post stroke shoulder pain. |
| Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Side in Patients With High Severity Post Stroke Shoulder Pain | Baseline | 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 |
Countries
United States
Participant flow
Recruitment details
All participants were enrolled at Johns Hopkins Hospital.
Pre-assignment details
Of 46 consented participants, 42 met inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Paretic - High Severity 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. | 24 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No analyzable imaging data | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Paretic - Low Severity | Paretic - High Severity | Total |
|---|---|---|---|
| Age, Continuous | 59.59 years STANDARD_DEVIATION 12.21 | 59.67 years STANDARD_DEVIATION 9.56 | 59.63 years STANDARD_DEVIATION 10.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 24 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 14 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 10 Participants | 6 Participants | 16 Participants |
| Sex: Female, Male Female | 7 Participants | 14 Participants | 21 Participants |
| Sex: Female, Male Male | 15 Participants | 10 Participants | 25 Participants |
| Time since stroke | 49.64 Months STANDARD_DEVIATION 45.55 | 36.38 Months STANDARD_DEVIATION 32.69 | 42.72 Months STANDARD_DEVIATION 39.49 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paretic | T1 Rho MRI Relaxation Time of Shoulder External Rotator (Milliseconds) | 29.09 milliseconds | Standard Deviation 3.02 |
| Non-Paretic | T1 Rho MRI Relaxation Time of Shoulder External Rotator (Milliseconds) | 27.15 milliseconds | Standard Deviation 2.2 |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paretic | T1 Rho MRI Relaxation Time of Shoulder Internal Rotator (Milliseconds) | 31.83 milliseconds | Standard Deviation 3.54 |
| Non-Paretic | T1 Rho MRI Relaxation Time of Shoulder Internal Rotator (Milliseconds) | 30.96 milliseconds | Standard Deviation 3.6 |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paretic | Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Muscles | 46.54 Shear strain percentage | Standard Deviation 19.81 |
| Non-Paretic | Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Muscles | 35.37 Shear strain percentage | Standard Deviation 13.95 |
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
Time frame: Baseline
Population: Ultrasound data were collected from 18/33 participants with high severity PSSP to compare paretic side with non-paretic side.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paretic | Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Side in Patients With High Severity Post Stroke Shoulder Pain | 47.46 Shear strain percentage | Standard Deviation 20.76 |
| Non-Paretic | Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Side in Patients With High Severity Post Stroke Shoulder Pain | 35.67 Shear strain percentage | Standard Deviation 12.86 |