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

NCT03291197 | Completed Phase 4 Results

• 1 other identifier: 20170066-01H
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Inter-rater Agreement of Budapest Criteria

  12 months

Study Arms (1)

Open label treatment

EXPERIMENTAL

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

Interventions

Suprascapular and median nerve blocks DRUG

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

Also known as: Bupivacaine, kenalog

Open label treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Elisabeth Bruyere Hospital

Ottawa, Ontario, K1N5C8, Canada

Location

MeSH Terms

Conditions

Reflex Sympathetic Dystrophy; Complex Regional Pain Syndromes

Interventions

Bupivacaine; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and 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).

Results Point of Contact

• Title: Dr. Marc Monsour
• Organization: Physical Medicine and Rehabilitation Ottawa Resident

mmonsour051@gmail.com

6137377350

Study Officials

• T Mark Campbell, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label preliminary study testing the tolerability of the procedure.

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: October 15, 2017
• Primary Completion: October 14, 2018
• Study Completion: October 14, 2018
• Last Updated: September 30, 2019
• Results First Posted: September 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)