Trial Outcomes & Findings for Quantifying Myofascial Dysfunction in Post-Stroke Pain (NCT NCT05762679)

Last Updated: 2025-07-09

Results Overview

Comparison of T1rho (T1ρ) MRI relaxation time of infraspinatus muscles on the paretic and non-paretic sides of patients with post stroke shoulder pain.

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

Baseline

Results posted on

2025-07-09

Participant Flow

All participants were enrolled at Johns Hopkins Hospital.

Of 46 consented participants, 42 met inclusion criteria.

Unit of analysis: Shoulders

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	42 84
Overall Study Paretic Low-Severity	20 20
Overall Study Paretic High-Severity	22 22
Overall Study Non-paretic	42 42
Overall Study COMPLETED	40 80
Overall Study NOT COMPLETED	2 4

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	1
Overall Study No analyzable imaging data	1

Baseline Characteristics

Quantifying Myofascial Dysfunction in Post-Stroke Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paretic - Low Severity n=22 Participants 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.	Paretic - High Severity n=24 Participants 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.	Total n=46 Participants Total of all reporting groups
Age, Continuous	59.59 years STANDARD_DEVIATION 12.21 • n=5 Participants	59.67 years STANDARD_DEVIATION 9.56 • n=7 Participants	59.63 years STANDARD_DEVIATION 10.78 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Time since stroke	49.64 Months STANDARD_DEVIATION 45.55 • n=5 Participants	36.38 Months STANDARD_DEVIATION 32.69 • n=7 Participants	42.72 Months STANDARD_DEVIATION 39.49 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Comparison of T1rho (T1ρ) MRI relaxation time of infraspinatus muscles on the paretic and non-paretic sides of patients with post stroke shoulder pain.

Outcome measures

Outcome measures
Measure	Paretic n=31 shoulder Shoulder/side with stiffness due to Stroke.	Non-Paretic n=31 shoulder Healthy side/shoulder.
T1 Rho MRI Relaxation Time of Shoulder External Rotator (Milliseconds)	29.09 milliseconds Standard Deviation 3.02	27.15 milliseconds Standard Deviation 2.20

PRIMARY outcome

Timeframe: 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.

Comparison of T1rho (T1ρ) MRI relaxation time of pectoralis major muscles on paretic and non-paretic shoulders in patients with post stroke shoulder pain.

Outcome measures

Outcome measures
Measure	Paretic n=31 shoulder Shoulder/side with stiffness due to Stroke.	Non-Paretic n=31 shoulder Healthy side/shoulder.
T1 Rho MRI Relaxation Time of Shoulder Internal Rotator (Milliseconds)	31.83 milliseconds Standard Deviation 3.54	30.96 milliseconds Standard Deviation 3.60

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Paretic n=33 shoulder Shoulder/side with stiffness due to Stroke.	Non-Paretic n=33 shoulder Healthy side/shoulder.
Ultrasound Shear Strain Percentage Between Paretic vs. Non-paretic Muscles	46.54 Shear strain percentage Standard Deviation 19.81	35.37 Shear strain percentage Standard Deviation 13.95

PRIMARY outcome

Timeframe: Baseline

Population: Ultrasound data were collected from 18/33 participants with high severity PSSP to compare paretic side with non-paretic side.

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

Outcome measures

Outcome measures
Measure	Paretic n=18 shoulder Shoulder/side with stiffness due to Stroke.	Non-Paretic n=18 shoulder Healthy side/shoulder.
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	35.67 Shear strain percentage Standard Deviation 12.86

Adverse Events

Subjects Post-stroke

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Preeti Raghavan

Johns Hopkins school of medicine

Phone: 9174889626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place