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

Primary Purpose

Shoulder Hand Syndrome, Complex Regional Pain Syndromes

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Suprascapular and median nerve blocks
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Shoulder Hand Syndrome focused on measuring Suprascapular nerve block, Median nerve block, CRPS, Shoulder hand syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Elisabeth Bruyere Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open label treatment

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 19, 2017
Last Updated
September 3, 2019
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03291197
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
October 14, 2018 (Actual)
Study Completion Date
October 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Hand Syndrome, Complex Regional Pain Syndromes
Keywords
Suprascapular nerve block, Median nerve block, CRPS, Shoulder hand syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open label preliminary study testing the tolerability of the procedure.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open label treatment
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Suprascapular and median nerve blocks
Other Intervention Name(s)
Bupivacaine, kenalog
Intervention Description
Ultrasound guided injection of the median and suprascapular nerve of the affected side.
Primary Outcome Measure Information:
Title
Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks
Description
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.
Time Frame
12 months
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
measured at baseline, within 1 hour after, and 2 weeks post intervention
Secondary Outcome Measure Information:
Title
Inter-rater Agreement of Budapest Criteria
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T Mark Campbell, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elisabeth Bruyere Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N5C8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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