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Phase 4 N=5 Other

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

Shoulder Hand Syndrome · Complex Regional Pain Syndromes

Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks — 5 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Suprascapular and median nerve blocks (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Ottawa Hospital Research Institute
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks
5
PRIMARY
Visual Analog Scale (VAS)
75; 17; 22; 36; 16; 28 0.043 sig
SECONDARY
Inter-rater Agreement of Budapest Criteria
0.75

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.

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 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03291197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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