Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Assessing the Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome - a Feasibility Study

Conditions
-----------------
Shoulder Hand Syndrome, Complex Regional Pain Syndromes

Intervention / Treatment
-----------------
* Drug: Suprascapular and median nerve blocks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are required to be 18 years of age or older and have a presumptive diagnosis of SHS post-stroke with a minimum visual analog scale of 40mm (greater than 40mm is considered moderate pain). Exclusion Criteria: Subjects will be excluded from the study if they have significant cognitive impairment (mini-mental state examination <23) and language deficits (difficulty cooperating due to aphasia) as this may affect their response to the outcome measures. Subjects with uncontrolled hypertension (>180/110), septicemia, and brachial plexus injuries will be excluded. Patients who are blind and deaf will also be excluded, as they will be unable to adequately complete the post-procedure survey and VAS. Patients on anticoagulation medications will also be excluded on a case-by-case basis and medications will be held prior to injection if required for safety. Patients with INR >1.5 will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Open label preliminary study testing the tolerability of the procedure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label treatment<br>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<br>* Ultrasound guided injection of the median and suprascapular nerve of the affected side.<br>* Other names: Bupivacaine, kenalog;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suprascapular nerve block, Median nerve block, CRPS, Shoulder hand syndrome