Trial Outcomes & Findings for Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome (NCT NCT03291197)

Last Updated: 2019-09-30

Results Overview

To evaluate the tolerability of ultrasound-guided suprascapular and median nerve blocks in stroke patients with SHS as determined using the Budapest criteria. Since tolerability is a subjective measure, it will be defined by a composite outcome including: A) Pain score prior to, during, and immediately following the procedure as measured by the visual analog scale (VAS); B) the rate of serious adverse events associated with this procedure; and C) the level of patient acceptance and satisfaction as determined by a validated post-procedure survey.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

12 months

Results posted on

2019-09-30

Participant Flow

Recruitment period was from September 2017 to 2018. This was a 12 month period in which patient with shoulder and hand pain following stroke were recruited.

All participants were recruited to for suprascapular and median nerve blocks once a diagnosis of shoulder-hand-syndrome was made using the Budapest criteria

Participant milestones

Participant milestones
Measure	Open Label Treatment These patients received suprascapular and median nerve blocks for shoulder hand syndrome. Investigators assessed the tolerability of his procedure using pre-defined criteria (outlined elsewhere). Suprascapular and median nerve blocks: Ultrasound guided injection of the median and suprascapular nerve of the affected side.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Treatment n=5 Participants These patients will receive suprascapular and median nerve blocks for shoulder hand syndrome. Investigators will assess the tolerability of his procedure using pre-defined criteria (outlined elsewhere). Suprascapular and median nerve blocks: Ultrasound guided injection of the median and suprascapular nerve of the affected side. Outcome measure were recorded for each participant before, immediately after, and 2 weeks post intervention.
Age, Continuous	68.5 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment Canada	5 participants n=5 Participants
Right Hand Dominant	5 Participants n=5 Participants
Mini Mental Status Exam	26.6 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants
Stroke Location Right middle cerebral artery	2 Participants n=5 Participants
Stroke Location Right posterior limb of internal capsule	2 Participants n=5 Participants
Stroke Location Left pons	1 Participants n=5 Participants
Time interval, days	12.8 Days STANDARD_DEVIATION 1.9 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All participants tolerated the intervention

Outcome measures

Outcome measures
Measure	Tolerability n=5 Participants Composite score of: a) change in VAS by \> 18mm; b) rate of serious adverse events; c) level of patient satisfaction	1 Hour VAS VAS measured within 1 hour after intervetion	2 Weeks VAS VAS measured 2 weeks post intervention
Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks	5 Participants	—	—

PRIMARY outcome

Timeframe: measured at baseline, within 1 hour after, and 2 weeks post intervention

Pain scale used to address a difference following intervention. Pain is measured on a horizontal line from 0 to 100mm, with 0 being no pain and 100 being the worst imaginable pain. Participants place a vertical mark on the line indicating their pain intensity.

Outcome measures

Outcome measures
Measure	Tolerability n=5 Participants Composite score of: a) change in VAS by \> 18mm; b) rate of serious adverse events; c) level of patient satisfaction	1 Hour VAS n=5 Participants VAS measured within 1 hour after intervetion	2 Weeks VAS n=5 Participants VAS measured 2 weeks post intervention
Visual Analog Scale (VAS) Shoulder	75 score on a scale Interval 66.5 to 90.5	17 score on a scale Interval 0.0 to 29.5	22 score on a scale Interval 0.0 to 63.0
Visual Analog Scale (VAS) Hand	36 score on a scale Interval 24.5 to 80.5	16 score on a scale Interval 0.0 to 32.5	28 score on a scale Interval 0.0 to 57.0

SECONDARY outcome

Timeframe: 12 months

Investigators will assess the reproducibility of the Budapest clinical criteria for newly suspected cases of SHS. This will be achieved by determining the level of inter-rater agreement between a resident and a staff physician working in stroke rehabilitation. Investigators will thus determine if there is variability in the clinical diagnosis among physicians with different levels of expertise.

Outcome measures

Outcome measures
Measure	Tolerability n=5 Participants Composite score of: a) change in VAS by \> 18mm; b) rate of serious adverse events; c) level of patient satisfaction	1 Hour VAS VAS measured within 1 hour after intervetion	2 Weeks VAS VAS measured 2 weeks post intervention
Inter-rater Agreement of Budapest Criteria	0.75 Intraclass correlation coefficient	—	—

Adverse Events

Tolerability

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. Marc Monsour

Physical Medicine and Rehabilitation Ottawa Resident

Phone: 6137377350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place