Complex Regional Pain Syndromes, Shoulder Hand Syndrome
Conditions
Keywords
Suprascapular nerve block, Median nerve block, CRPS, Shoulder hand syndrome
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.
Interventions
DRUGSuprascapular and median nerve blocks
Ultrasound guided injection of the median and suprascapular nerve of the affected side.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open label preliminary study testing the tolerability of the procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
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 details
All participants were recruited to for suprascapular and median nerve blocks once a diagnosis of shoulder-hand-syndrome was made using the Budapest criteria
Participants by arm
| Arm | Count |
|---|---|
| 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).
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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Open Label Treatment | — |
|---|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 9.5 | — |
| Mini Mental Status Exam | 26.6 units on a scale STANDARD_DEVIATION 1.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 5 participants | — |
| Right Hand Dominant | 5 Participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
| Stroke Location Left pons | 1 Participants | — |
| Stroke Location Right middle cerebral artery | 2 Participants | — |
| Stroke Location Right posterior limb of internal capsule | 2 Participants | — |
| Time interval, days | 12.8 Days STANDARD_DEVIATION 1.9 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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.
Time frame: 12 months
Population: All participants tolerated the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tolerability | Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks | 5 Participants |
Primary
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.
Time frame: measured at baseline, within 1 hour after, and 2 weeks post intervention
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tolerability | Visual Analog Scale (VAS) | Shoulder | 75 score on a scale |
| Tolerability | Visual Analog Scale (VAS) | Hand | 36 score on a scale |
| 1 Hour VAS | Visual Analog Scale (VAS) | Shoulder | 17 score on a scale |
| 1 Hour VAS | Visual Analog Scale (VAS) | Hand | 16 score on a scale |
| 2 Weeks VAS | Visual Analog Scale (VAS) | Shoulder | 22 score on a scale |
| 2 Weeks VAS | Visual Analog Scale (VAS) | Hand | 28 score on a scale |
Comparison: Our study was not powered to perform statistical analysis though was still conduct to look for a trend in reduction of VAS.p-value: 0.043Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tolerability | Inter-rater Agreement of Budapest Criteria | 0.75 Intraclass correlation coefficient |