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

Complex Regional Pain Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291197
• Other study ID #: 20170066-01H
• Status: Completed
• Phase: Phase 4
• Start date: October 15, 2017
• Est. completion date: October 14, 2018

Study information

• Verified date: July 2019
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 14, 2018
• Est. primary completion date: October 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Shoulder Hand Syndrome
• Syndrome

Intervention

Drug:
• Suprascapular and median nerve blocks
Ultrasound guided injection of the median and suprascapular nerve of the affected side.

Locations

Country	Name	City	State
Canada	Elisabeth Bruyere Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 months
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.	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.	12 months