A Phase 4 interventional study of Suprascapular and median nerve blocks in Shoulder Hand Syndrome and Complex Regional Pain Syndromes, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by Ottawa Hospital Research Institute · Phase 4, Interventional, and Other
Shoulder-hand syndrome (SHS) in stroke patients is painful and lowers quality of life. Unfortunately, the cause of SHS is not known, diagnosing SHS can be difficult, and treating it can be hard. Recent research has shown that certain nerve blocks are good for treating shoulder pain for stroke patients, but no one has looked specifically as SHS. Investigators think that specific nerve blocks involving a shoulder nerve (the suprascapular, or SSc nerve) and a hand nerve (the median nerve) will be helpful in reducing SHS pain. Investigators will use ultrasound guidance to accurately inject these nerves. These injections have never been described for SHS patients however, so investigators want to make sure people with SHS can go through with the injections without too much pain or discomfort. That is, the investigators want to test the tolerance of these injections for people with SHS. Investigators are also hoping to better understand how consistent a set of diagnostic criteria, called the Budapest criteria, are at diagnosing SHS in order to be able to accurately diagnose this condition.
43 studies on the registry are indexed under Reflex Sympathetic Dystrophy; 4 are open to participants now.
This study's enrollment of 5 is below the median of 48 across 35 interventional studies indexed under Reflex Sympathetic Dystrophy.
Browse Reflex Sympathetic Dystrophy studies →Ottawa Hospital Research Institute is the lead sponsor of 547 studies on the registry; 99 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Suprascapular and median nerve blocks
Ultrasound guided injection of the median and suprascapular nerve of the affected side.
Also known as: Bupivacaine, kenalog
Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks
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.
Time frame: 12 months
Visual Analog Scale (VAS)
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.
Time frame: measured at baseline, within 1 hour after, and 2 weeks post intervention
Inter-rater Agreement of Budapest Criteria
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.
Time frame: 12 months
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.
| Milestone | Open Label Treatment |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
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.
| Participants | Tolerability |
|---|---|
| Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks | 5 |
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.
| score on a scale | Baseline VAS | 1 Hour VAS | 2 Weeks VAS |
|---|---|---|---|
| Shoulder | 75 (66.5 to 90.5) | 17 (0 to 29.5) | 22 (0 to 63) |
| Hand | 36 (24.5 to 80.5) | 16 (0 to 32.5) | 28 (0 to 57) |
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.
| Intraclass correlation coefficient | All Participants |
|---|---|
| Inter-rater Agreement of Budapest Criteria | 0.75 |
Collected over during and immediately following the procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tolerability | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Open Label Treatment |
|---|---|
| Mean | 68.5 ± 9.5 |
| Sex: Female, Male(Participants) | Open Label Treatment |
|---|---|
| Female | 2 |
| Male | 3 |
| Race and Ethnicity Not Collected(Participants) | Open Label Treatment |
|---|
| Region of Enrollment(participants) | Open Label Treatment |
|---|---|
| Canada | 5 |
| Right Hand Dominant(Participants) | Open Label Treatment |
|---|---|
| Count of participants | 5 |
| Mini Mental Status Exam(units on a scale) | Open Label Treatment |
|---|---|
| Mean | 26.6 ± 1.1 |
| Stroke Location(Participants) | Open Label Treatment |
|---|---|
| Right middle cerebral artery | 2 |
| Right posterior limb of internal capsule | 2 |
| Left pons | 1 |
| Time interval, days(Days) | Open Label Treatment |
|---|---|
| Mean | 12.8 ± 1.9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Ran from Oct 2017 to primary completion in Oct 2018, 11 months.
Results were first posted in Sep 2019, 11 months after primary completion.
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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