Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06718413

Myofascial Dysfunction in Post Stroke Shoulder Pain

Shoulder pain is extremely common after stroke and occurs in 30-70% of patients. The pain may begin as early as one week after stroke, although peak onset and severity occurs around four months, and persists into the chronic stage. Chronic post stroke shoulder pain (PSSP) interferes with motor recovery, decreases quality of life, and contributes to depression. PSSP is thought to be caused mainly by damage to the myofascial tissues around the shoulder joint. Interestingly, an MRI study in patients with PSSP showed that the degree of structural damage to the muscles did not correlate with the degree of pain. Thus, 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 hyaluronic acid (HA) in muscle and its fascia can cause myofascial dysfunction. HA is a glycosaminoglycan (GAG) consisting of long-chain polymers of disaccharide units of glucuronic acid and N-acetylglucosamine and is a chief constituent of the extracellular matrix of muscle. In physiologic quantities, HA functions as a lubricant and a viscoelastic shock absorber, enabling force transmission during contraction and stretch. Reduced joint mobility and spasticity result in focal accumulation and alteration of HA in muscle. This can lead to the development of stiff areas and taut bands, dysfunctional gliding of deep fascia and muscle layers, reduced range of motion (ROM), and pain. However, the association of muscle HA accumulation with PSSP has not been established.

The investigators have quantified the concentration of HA in muscle using T1rho (T1ρ) MRI and found that T1ρ relaxation time is increased in post stroke shoulder pain and stiffness. Furthermore, dynamic US imaging using shear strain mapping can quantify dysfunctional gliding of muscle that may generate pain during ROM. Myofascial dysfunction can result in non-painful reduction in ROM (latent PSSP), which may become painful due to episodic overuse injury producing greater shear dysfunction (active PSSP). Hence, shear strain mapping may differentiate between latent versus active PSSP. Thus, quantitative Motor Recovery (MR) and US imaging may serve as useful biomarkers to elucidate the pathophysiology of myofascial dysfunction.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Ning Cao, MD

CONTACT

718-801-0026

Preeti Raghavan, MD

CONTACT

917-488-9263

About this study

Aim 1: Quantify the extent of HA accumulation in shoulder muscles using T1rho MRI before and after treatment with hyaluronidase injections versus placebo in patients with PSSP. Hypothesis: The primary objective will be to demonstrate that dysfunctional shoulder girdle muscles on the paretic side in patients with PSSP will show decreased T1ρ relaxation times in the infraspinatus muscle after treatment with hyaluronidase injections compared with placebo 5-7 weeks post-injection.

Aim 2. Determine maximum sheer strain in shoulder muscles using US shear strain mapping before and after treatment with hyaluronidase injections versus placebo in patients with PSSP. Research Hypothesis: Shear strain on the paretic side in patients with PSSP measured using ultrasound shear mobility between the pectoralis major and minor muscles will decrease after treatment with hyaluronidase injections compared with placebo 5-7 weeks post-injection.

Aim 3. Assess the impact of hyaluronidase injections compared with placebo on shoulder pain, pain free range of motion, upper limb motor impairment, function and quality of life in patients with PSSP. Hypothesis: Hyaluronidase injections compared with placebo in patients with PSSP will lead to (1) reduced pain as assessed using the pain questionnaires and lower pain-pressure thresholds with quantitative sensory testing using an algometer; (2) increased pain free range of motion in most affected shoulder joints; (3) reduced upper limb motor impairment measured using the Fugl-Meyer Scale; (4) increased function measured using the Wolf Motor Function Test; and (5) improved quality of life measured using the Stroke Specific Quality of Life scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥18 years;
  • hemiparesis from an ischemic or hemorrhagic stroke;
  • time since cerebral injury 3-180 months prior;
  • show a difference of more than 10 degrees of passive ER-ROM between non-paretic and paretic shoulders with or without pain
  • ability to give informed consent and HIPAA authorization, and comply with study protocols;

Exclusion criteria

  • treatment of spasticity with Botulinum toxin or intrathecal baclofen within the past three months, phenol injections within the past 12 months, or ongoing adjustment of anti-spastic medications;
  • other neurologic condition that may affect motor response (e.g., Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), MS);
  • clinically significant cognitive dysfunction with score <19 on Folstein's Mini Mental Status Examination or positive depression screening on the Patient Health Questionnaire (PHQ)-9;
  • pregnancy;
  • known hypersensitivity to hyaluronidase;
  • standard contraindications for MRI;
  • have non-musculoskeletal PSSP such as only central pain or chronic regional pain syndrome (CRPS)
  • any condition that will preclude the patient from completing the protocol as determined by the PI.

Treatment and study plan

hyaluronidase plus saline

Drug

Injection of study drug with saline

Other names: Treatment Arm

Saline

Drug

injection of normal saline and no study drug

Other names: Control Arm

Primary outcomes

  1. T1ρ relaxation times (ms) in the treatment group

    Time frame: Baseline, up to 7 weeks post first injection

    Aim 1: T1ρ relaxation times in the treatment group. The primary endpoint will be change in T1ρ relaxation times on MRI in the shoulder girdle muscles of the paretic side between the baseline visit and 5-7 weeks post-first injection (i.e., post injection follow up at Visit 5/ end of Phase 1).

Secondary outcomes

  1. Ultrasound shear strain

    Time frame: 7 weeks

    Percent shear strain obtained via ultrasound in the two groups. Higher shear strain is better.

  2. Pain rating as assessed by algometer

    Time frame: 7 weeks

    Pain rating on quantitative sensory testing of shoulder muscles. Lower pain rating is better.

  3. Pain free range of motion

    Time frame: 7 weeks

    Range of motion for the most affected shoulder movement. Higher range of motion is better.

  4. Upper limb motion impairment as assessed by the Fugl-Meyer Scale

    Time frame: 7 weeks

    Upper limb Fugl-Meyer scale; score range 0-66 with higher numbers reflecting less arm impairment

  5. Upper limb function as assessed by Wolf Motor Function Test (time)

    Time frame: 7 weeks

    Participants are given a battery of functional tasks that are timed and scored on movement quality. Score range is 0-120, lower scores being better.

  6. Quality of life as assessed by the Stroke Impact Scale

    Time frame: 7 weeks

    Scores range from 0-100, with higher score showing better quality of life and lower stroke impact.

Study contacts

Contact information is provided by the study sponsor or research team.

Ning Cao, MD

CONTACT

[email protected]

718-801-0026

Preeti Raghavan

CONTACT

[email protected]

410-955-0703

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Quantifying and Treating Myofascial Dysfunction in Post Stroke Shoulder Pain

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 5, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.