Clinical trial NCT03291197: Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome
Official title: Assessing the Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shoulder Hand Syndrome
Complex Regional Pain Syndromes
Keywords: Suprascapular nerve block
Median nerve block
CRPS
Shoulder hand syndrome
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label preliminary study testing the tolerability of the procedure.
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks
timeFrame: 12 months
measure: Visual Analog Scale (VAS)
timeFrame: measured at baseline, within 1 hour after, and 2 weeks post intervention
Secondary outcomes:
measure: Inter-rater Agreement of Budapest Criteria
timeFrame: 12 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Elisabeth Bruyere Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: T Mark Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References: