Phase 4
Completed N=5
Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome
Shoulder Hand Syndrome · Complex Regional Pain Syndromes
Source: ClinicalTrials.gov NCT03291197 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks — 5 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-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 | — |
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.
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. Informational only — not medical advice.