Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome
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|ClinicalTrials.gov Identifier: NCT03291197|
Recruitment Status : Completed
First Posted : September 25, 2017
Results First Posted : September 30, 2019
Last Update Posted : September 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Hand Syndrome Complex Regional Pain Syndromes||Drug: Suprascapular and median nerve blocks||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label preliminary study testing the tolerability of the procedure.|
|Masking:||None (Open Label)|
|Official Title:||Assessing the Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome - a Feasibility Study|
|Actual Study Start Date :||October 15, 2017|
|Actual Primary Completion Date :||October 14, 2018|
|Actual Study Completion Date :||October 14, 2018|
Experimental: 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).
Drug: Suprascapular and median nerve blocks
Ultrasound guided injection of the median and suprascapular nerve of the affected side.
Other Name: Bupivacaine, kenalog
- Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks [ Time Frame: 12 months ]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.
- Visual Analog Scale (VAS) [ Time Frame: 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.
- Inter-rater Agreement of Budapest Criteria [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291197
|Elisabeth Bruyere Hospital|
|Ottawa, Ontario, Canada, K1N5C8|
|Principal Investigator:||T Mark Campbell, MD||Ottawa Hospital Research Institute|