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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label treatment | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suprascapular and median nerve blocks | Drug | Ultrasound guided injection of the median and suprascapular nerve of the affected side. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | measured at baseline, within 1 hour after, and 2 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| T Mark Campbell, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elisabeth Bruyere Hospital | Ottawa | Ontario | K1N5C8 | Canada |
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All participants were recruited to for suprascapular and median nerve blocks once a diagnosis of shoulder-hand-syndrome was made using the Budapest criteria
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Treatment | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants tolerated the intervention | Posted | Count of Participants | Participants | 12 months |
|
during and immediately following the procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tolerability | Composite score | 0 |
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Some of these results should be considered hypothesis-generating due to the small sample size of our study, and the inability to assess other factors that may affect the response to pain (i.e. co-morbidities, psychological profile).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marc Monsour | Physical Medicine and Rehabilitation Ottawa Resident | 6137377350 | mmonsour051@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2017 | Aug 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012019 | Reflex Sympathetic Dystrophy |
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Open label preliminary study testing the tolerability of the procedure.
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| 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Right Hand Dominant | Count of Participants | Participants |
|
| Mini Mental Status Exam | Cognitive test. Total score out of 30 points. A total score below 24 is considered cognitively impaired. We are not including subscales and report only on the total score. | Mean | Standard Deviation | units on a scale |
|
| Stroke Location | Count of Participants | Participants |
|
| Time interval, days | The number of days from the date of study enrolment to the date the participants received peripheral nerve injections. | Mean | Standard Deviation | Days |
|
|
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| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | measured at baseline, within 1 hour after, and 2 weeks post intervention |
|
|
|
|
| Secondary | 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. | Posted | Number | Intraclass correlation coefficient | 12 months |
|
|
|
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D000588 |
| Amines |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
|