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

• Sponsor: Ottawa Hospital Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03291197
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 0.4

Study Details

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
• 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.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: Oct 15, 2017
• Actual Primary Completion Date: Oct 14, 2018
• Actual Study Completion Date: Oct 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 Names: Bupivacaine, kenalog

Outcome Measures

Primary Outcome Measures

1. Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks [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) [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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)

• Study Protocol and Statistical Analysis Plan - Apr 8, 2017

More Information

Publications

None provided.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT03291197
• Other Study ID Numbers: 20170066-01H
• First Posted: Sep 25, 2017
• Last Update Posted: Sep 30, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• 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; Bupivacaine

Study Results

Participant Flow

Recruitment Details	Recruitment period was from September 2017 to 2018. This was a 12 month period in which patient with shoulder and hand pain following stroke were recruited.
Pre-assignment Detail	All participants were recruited to for suprascapular and median nerve blocks once a diagnosis of shoulder-hand-syndrome was made using the Budapest criteria

Arm/Group Title	Open Label Treatment
Arm/Group Description	These patients received suprascapular and median nerve blocks for shoulder hand syndrome. Investigators assessed the tolerability of his procedure using pre-defined criteria (outlined elsewhere). Suprascapular and median nerve blocks: Ultrasound guided injection of the median and suprascapular nerve of the affected side.
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Open Label Treatment
Arm/Group 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). Suprascapular and median nerve blocks: Ultrasound guided injection of the median and suprascapular nerve of the affected side. Outcome measure were recorded for each participant before, immediately after, and 2 weeks post intervention.
Overall Participants	5
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.5 (9.5)
Sex: Female, Male (Count of Participants)
Female	2 40%
Male	3 60%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Canada	5 100%
Right Hand Dominant (Count of Participants)
Count of Participants [Participants]	5 100%
Mini Mental Status Exam (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	26.6 (1.1)
Stroke Location (Count of Participants)
Right middle cerebral artery	2 40%
Right posterior limb of internal capsule	2 40%
Left pons	1 20%
Time interval, days (Days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Days]	12.8 (1.9)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants tolerated the intervention

Arm/Group Title	Tolerability
Arm/Group Description	Composite score of: a) change in VAS by > 18mm; b) rate of serious adverse events; c) level of patient satisfaction
Measure Participants	5
Count of Participants [Participants]	5 100%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baseline VAS	1 Hour VAS	2 Weeks VAS
Arm/Group Description	visual analog pain scale at baseline prior to intervention	VAS measured within 1 hour after intervetion	VAS measured 2 weeks post intervention
Measure Participants	5	5	5
Shoulder	75	17	22
Hand	36	16	28

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tolerability, 1 Hour VAS
	Comments	Our study was not powered to perform statistical analysis though was still conduct to look for a trend in reduction of VAS.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.043
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	All participants will be assessed using the Budapest Criteria by both a staff physician and a resident. The inter-rater agreement will be determined to assess the reproducibility of the Budapest clinical criteria for newly suspected cases of SHS.
Measure Participants	5
Number [Intraclass correlation coefficient]	0.75

Adverse Events

Time Frame	during and immediately following the procedure
Arm/Group Title	Tolerability
Arm/Group Description	Composite score
All Cause Mortality
	Tolerability
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	Tolerability
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Tolerability
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

Some of these results should be considered hypothesis-generating due to the small sample size of our study, and the inability to assess other factors that may affect the response to pain (i.e. co-morbidities, psychological profile).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.