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

• ClinicalTrials.gov Identifier: NCT03291197
• Recruitment Status: Completed
• First Posted: September 25, 2017
• Results First Posted: September 30, 2019
• Last Update Posted: September 30, 2019
• Sponsor: Ottawa Hospital Research Institute
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Shoulder Hand Syndrome; Complex Regional Pain Syndromes	Drug: Suprascapular and median nerve blocks	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open label preliminary study testing the tolerability of the procedure.
• Masking: None (Open Label)
• Primary Purpose: Other
• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, Ontario

Elisabeth Bruyere Hospital

Ottawa, Ontario, Canada, K1N5C8

Sponsors and Collaborators

Ottawa Hospital Research Institute

Investigators

• Principal Investigator: T Mark Campbell, MD; Ottawa Hospital Research Institute

  Study Documents (Full-Text)

Documents provided by Ottawa Hospital Research Institute:

Study Protocol and Statistical Analysis Plan  [PDF] April 8, 2017

More Information

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT03291197
• Other Study ID Numbers: 20170066-01H
• First Posted: September 25, 2017
• Results First Posted: September 30, 2019
• Last Update Posted: September 30, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:

Suprascapular nerve block; Median nerve block; CRPS; Shoulder hand syndrome

Additional relevant MeSH terms:

Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Disease; Pathologic Processes; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents