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

NCT ID: NCT03291197

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-15
• Study Completion Date: 2018-10-14

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.

Conditions

Shoulder Hand Syndrome; Complex Regional Pain Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Suprascapular and median nerve blocks

Intervention Type: DRUG

Ultrasound guided injection of the median and suprascapular nerve of the affected side.

Interventions

Suprascapular and median nerve blocks

Ultrasound guided injection of the median and suprascapular nerve of the affected side.

Intervention Type: DRUG

Other Intervention Names

Bupivacaine, kenalog

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

T Mark Campbell, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Elisabeth Bruyere Hospital

Ottawa, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20170066-01H

Identifier Type: -

Identifier Source: org_study_id