## Protocol Section
### Identification Module
**NCT ID:** NCT05762679

**Acronym:** Myofascial

**Brief Title:** Quantifying Myofascial Dysfunction in Post-Stroke Pain

**Official Title:** Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management

#### Organization Study ID Info
**ID:** IRB00354876
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins University
#### Secondary ID Infos
**ID:** 1R61AT012279-01
**Link:** https://reporter.nih.gov/quickSearch/1R61AT012279-01
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-03

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-02

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-02-28

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2023-03-10
**Type:** ACTUAL
**Study First Submit Date:** 2023-02-28
**Study First Submit QC Date:** 2023-02-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Center for Complementary and Integrative Health (NCCIH)

**Class:** OTHER

**Name:** New York University

**Class:** OTHER

**Name:** George Mason University

#### Lead Sponsor

**Class:** OTHER

**Name:** Johns Hopkins University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Myofascial Dysfunction

**Keywords:**

- Glycosaminoglycan

- Hyaluronic acid

- Post stroke shoulder pain

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Latent 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.

**Label:** Latent PSSP

#### Arm Group 2

**Description:** Active 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.

**Label:** Active PSSP

### Outcomes Module

#### Primary Outcomes

**Description:** Comparison of T1rho (T1ρ) MRI of pectoralis major and infraspinatus muscles in paretic and non-paretic shoulders

**Measure:** To quantify the extent of HA accumulation in shoulder muscles using quantitative MRI and US.

**Time Frame:** Baseline

**Description:** Comparison of peak lateral shear strain of pectoralis major and infraspinatus muscles in paretic latent vs active PSSP compared to non-paretic shoulders

**Measure:** To distinguish between latent versus active PSSP using US shear strain mapping of the same muscles on the paretic side compared with the non-paretic side.

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** We will enroll 20 patients each with latent PSSP and active PSSP group, repectively.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** praghav3@jh.edu

**Name:** Preeti Raghavan, MD

**Phone:** 410-955-0703

**Role:** CONTACT

**Contact 2:**

**Email:** jhuan190@jh.edu

**Name:** Jonny Huang, DPT

**Phone:** (410) 614-1347

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Baltimore

**Contacts:**

***Contact 1:***

- **Email:** jhuan190@jh.edu

- **Name:** Jonny Huang, DPT

- **Phone:** 410-614-1347

- **Role:** CONTACT

***Contact 2:***

- **Name:** Preeti Raghavan, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Johns Hopkins University School of Medicine

**State:** Maryland

**Status:** RECRUITING

**Zip:** 21287

#### Overall Officials

**Official 1:**

**Affiliation:** Johns Hopkins University

**Name:** Preeti Raghavan, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M21907

- Name: Shoulder Pain

- Relevance: LOW

- As Found: Unknown

- ID: M22306

- Name: Stroke

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9878

- Name: Hyaluronic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
