Clinical trial NCT03291197
Conditions: Shoulder Hand Syndrome Complex Regional Pain Syndromes
Keywords: Suprascapular nerve block Median nerve block CRPS Shoulder hand syndrome
Sponsor: Ottawa Hospital Research Institute
Start date: 2017-10-15; Completion date: 2018-10-14
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Detailed description:

Arms: arm 1: 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).
Interventions: intervention 1: Suprascapular and median nerve blocks
Intervention descriptions: intervention 1: Ultrasound guided injection of the median and suprascapular nerve of the affected side.

Protocol documents:
Prot_SAP_000.pdf: 
Assessing the tolerability of suprascapular and median nerve blocks for the treatment of 
shoulder-hand syndrome - a feasibility study 
 
OSHN-REB: 20170066-01H 
Bruyere REB: M16-17-024 
NCT03291197 
 
Date: April 8 2017 
 
 


Assessing the tolerability of suprascapular and median nerve blocks for the treatment of 
shoulder-hand syndrome - a feasibility study 
 
INTRODUCTION 
 
Background and Rationale  
Chronic regional pain syndrome (CRPS) is a debilitating, painful condition characterized 
by severe pain of the shoulder and hand. It may occur in multiple settings, including post-
trauma, post-surgery, or in the hemiparetic upper limb following a stroke. When this occurs in 
stroke patients, it is also referred to as shoulder-hand syndrome (SHS). In SHS, the stroke-
affected upper extremity shows pathologic alterations including vasomotor (changes in 
temperature and skin colour); sudomotor (sweating and edema); motor signs/symptoms 
(weakness and tremor); trophic alterations of nails, hair, skin as well as joint contractures 
(Harden 2013). SHS is highly prevalent in the stroke population, affecting as many as 25% of 
these patients in Canada (Tepperman 1984).  Due to its progressive nature, SHS frequently 
leads to severe functional impairment and chronic morbidity. Thus, SHS has a significant impact 
on stroke recovery, patients’ ability to regain independence, and community reintegration 
(Kang 2012).  
 
The pathophysiology of SHS is poorly understood. The two most commonly accepted 
mechanisms include neurogenic inflammation and/or autonomic nervous system dysfunction 
(Bussa 2015).  Neurogenic inflammation may occur secondary to increased pro-inflammatory 
cytokines in the blood plasma and cerebral spinal fluid (Bussa 2013 and Taha 2007), and is 
supported by effective treatment with corticosteroids (Braus 1994; Kalita 2006; Rah 2012).  The 
putative autonomic nervous system dysfunction mechanism is based upon the observation that 
there is an increased sensitivity of blood vessels to catecholamines and adrenergic sensitivity by 
nociceptive neurons (Bussa 2013), as assessed during sympathetic nerve blockade (Meier 2009; 
Carroll 2009; Aydemir 2006). 
 
Due to the variability in how SHS presents itself, its clinical diagnosis can be challenging 
(Harden 2007). In order to address this challenge, a collaborative international task force has 
developed a set of validated diagnostic criteria, known as the Budapest criteria, which 
incorporates symptoms and signs of vasomotor, sudomotor, motor and trophic changes 
(Harden 2007 and 2013; see Appendix A). While the Budapest criteria have been validated in 
non-stroke populations (CRPS types 1 and 2), an important limitation is the lack of information 
regarding their reproducibility among users and within the stroke patient population. The 
sensitivity and specificity of the Budapest criteria in non-stroke populations has been reported 
to be 0.85 and 0.69, respectively (Harden 2013). To our knowledge, the inter-rater agreement 
of the Budapest criteria is unknown in the stroke population suffering from SHS.  
 
Due to the lack of knowledge regarding the pathophysiology of SHS, treatment options 
vary, focusing on both pharmacologic and non-pharmacologic treatments for neuropathic-type 
pain (Cacchio 2009; Kalita 2006). One of the most widely accepted treatments for SHS is the 
administration of a high-dose pulse of corticosteroids, follows by a rapid taper. Three studies 


have assessed this treatment approach and all have shown that pain is significantly reduced 
(Braus 1994; Kalita 2006; Rah 2012). Appendix B summarizes pharmacological, non-
pharmacological (physical therapy and mirror therapy) and procedural interventions 
(sympathetic stellate ganglion block). Despite multiple treatment options, SHS often remains 
refractory and severely disabling. 
 
Within the last decade, there has been exciting research in the field of peripheral nerve 
blockade for stroke patients with upper extremity pain. Jeon et al. (2014) evaluated 30 patients 
with hemiplegic shoulder pain (HSP) randomized to either intraarticular steroid injection, 
suprascapular nerve block (SSNB), or combined therapy. They showed a significant decrease in 
pain using the visual analog scale in all three groups at 1 hour, 1 week, and 1 month post-
injection (p=0.000). Adey-wakeling et al. (2013) equally randomized 64 patients with HSP to 
SSNB or placebo injection. There was a significant difference in visual analog scale pain 
reduction (18mm) in the experimental group compared to placebo group at 1 week, 4 weeks, 
and 12 weeks (p=0.02) post-injection. Yasar et al. (2011) randomized 26 patients with HSP to 
two groups (intraarticular steroid injection and SSNB). There was significant reduction in VAS 
pain at 1 hour, 1 week, and 1 month post-injection (p<0.001) (see Appendix C for more details). 
 
While these studies show promise for the management of generalized hemiplegic 
shoulder pain in the stroke population, to our knowledge, there has yet to be any study 
specifically evaluating the effect of peripheral nerve injection for the treatment of SHS.  As SHS 
is a highly painful condition that often presents with allodynia and hyperalgesia of the hand and 
shoulder (Harden 2013), the tolerability of an injection in or near these regions may preclude 
their use in this particular population. There is therefore a need to ensure the tolerability of 
such treatments prior to evaluating their efficacy in patients with SHS. Based on the pain 
distribution of SHS, we have specifically chosen to evaluate the combined tolerability of two 
well-described peripheral nerve blocks: suprascapular and median nerve blockades, both of 
which have been deemed safe and effective in other settings (Jeon 2014; Adey-wakeling 2013; 
Yasar 2011; Liebmann et al 2006).  
 
In order to evaluate the reproducibility of the Budapest criteria for SHS, we will measure 
the inter-rater agreement between 2 clinical assessors. Our preliminary findings would reassure 
investigators and funding agencies regarding the feasibility of conducting a larger clinical study. 
 
OBJECTIVES 
For this preliminary study, we have developed 2 independent Objectives: 
 
Objective 1: Tolerability of Suprascapular and Median Nerve Blockade 
We will 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. 


 
Hypothesis 1: Ultrasound-guided peripheral nerve blocks of the suprascapular and median 
nerves will be well tolerated by stroke patients with SHS. 
 
Objective 2: Inter-rater Agreement of Budapest Criteria 
We will assess the reproducibility of the Budapest clinical criteria for newly suspected 
cases of SHS. This will be achieved by estimating the level of inter-rater agreement between a 
resident and a staff physician working in stroke rehabilitation. We will therefore determine if 
there is variability in the clinical diagnosis among physicians with different levels of expertise.   
 
Hypothesis 2: There is good to excellent inter-rater reliability (>0.60) of the Budapest clinical 
criteria between these two assessors. 
 
MATERIALS AND METHODOLOGY 
1) Population 
Stroke patients with suspected shoulder-hand-syndrome (SHS) are most often identified 
on the inpatient stroke rehabilitation ward at Élisabeth Bruyère Hospital (EBH) or Saint 
Vincent’s Hospital (SVH) in Ottawa, ON. They are occasionally encountered in the outpatient 
stroke clinics at EBH. Patients with suspected SHS will be referred to Dr. Campbell (a physical 
medicine and rehabilitation physician who specializes in stroke rehabilitation) for evaluation. 
This has been discussed with the other physicians at EBH and SVH. Such patients most 
commonly present with a painful shoulder and painful edematous hand. Subjects will be 
recruited over a 12-month period from the inpatient stroke rehabilitation unit at EBH, the 
restorative care inpatient program at SVH, and the stroke outpatient clinic at EBH.   
 
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. 
 
2) Research procedures and instrumentation:  
 
a) Suprascapular and median nerve blocking procedure 
 
As part of their standard of care, all participants will receive their usual treatment for 
SHS as per Dr. Campbell’s discretion. Patients receiving corticosteroids usually receive a 


standardized regimen of prednisone 60mg daily from day 1 to 10 then a taper of 10mg daily, 
total treatment regimen is 15 days. While we will try to standardize this part of the treatment, 
it is possible that some patients may require a different treatment course, based on their 
response to therapy. Such patients will receive appropriate adjustments to care based on their 
clinical picture. Each participant will undergo an ultrasound-guided injection of the 
suprascapular nerve and median nerve by a trained radiologist or radiology fellow (under the 
supervision of the staff radiologist) at The Ottawa Hospital, General Campus. This will involve a 
subcutaneous injection of 1% lidocaine for local analgesia at each location followed by 1mL of 
0.5% bupivicaine and 40mg of triamcinolone. 
 
b) Ultrasound-guided nerve block technique: 
 
Median nerve block: probe will initially be centered over the volar wrist and the median nerve 
will be identified. The nerve has a typical honeycomb appearance and the probe will be moved 
proximally to the midforearm between the flexor digitorum superficialis and the flexor 
digitorum profundus at the midline of the forearm (Liebmann et al 2006). The identified nerve 
will then be injected. 
 
Suprascapular nerve block: is identified as a round hyperechoic structure at 4cm depth beneath 
the transverse scapular ligament in the scapular notch (Harmon and Hearty 2007). The 
identified nerve will then be injected. 
 
c) Assessment of pain pre- and post-procedure with the visual analog scale. 
 
The visual analog scale (VAS) is a subjective measure of pain on a scale of 0-100mm. The 
subjects will be supervised during the completion of VAS to minimized errors. The test-retest 
reliability of VAS has been shown to be good in literates (r = 0.94, p < 0.001) and in illiterates (r 
= 0.71, p < 0.001) (Hawker et al 2011). The VAS will be completed just prior to the procedure 
(scheduled for early morning), during the procedure, within 1 hour post-procedure, and 2 
weeks post- procedure.  
 
d) Detection of adverse events. 
 
The radiologist performing the procedure will report the immediate adverse events on 
the physician’s post-procedural survey (Appendix E). The participant will keep a logbook that 
will be returned 2 weeks post-procedure where they will list any adverse events.  Each 
participant will receive a pamphlet with instruction on how to identify these adverse events and 
how to record them. Adverse events that have been associated with peripheral nerve blocks 
include: 
• Increased pain during the procedure: the percentage of this is unknown in patients with 
SHS. Because of the high sensitivity to pain this may be increased. 
• Nerve injury (8-10%): symptoms of nerve injury include pain, tingling and paresthesia. 
This can also include motor and sensory deficits. This is a temporary effect with only 
about 1 in 200 people having symptoms 6 months after the procedure. 


• Hematoma: this is rare because a small gauge needle (22G or 25G) will be used as well 
direct pressure will be applied at the needle site following the procedures. 
• Local anesthetic systemic toxicity (LAST): accidental intravascular injection of local 
anesthetic. The clinical manifestations of LAST include mild symptoms (ringing in ears, 
tingling in lips, and agitation) to severe neurological (seizures) and cardiovascular signs 
(hypertension, hypotension, tachycardia, bradycardia, ventricular arrhythmia, cardiac 
arrest). This complication is very rare as precautions are taken during the procedure to 
avoid inadvertent intravascular injection. 
• Allergic reaction: this can be an allergic contact dermatitis or urticarial and anaphylaxis. 
Patient’s known to have allergies to local anesthetics will be given a substitute 
medication. 
• Infection: risk is negligible from a single-shot peripheral nerve block. 
• Secondary injury: reduced sensation after nerve block puts subjects at risk of tissue 
injury. 
 
e) Evaluation of the patient’s acceptance and satisfaction 
 
We will use an adapted post-procedure assessment questionnaire. The original 
questionnaire was used in a total of 566 patients for the purpose of determining the quality of 
multiple interventional pain management procedure (Zhou et al 2006). The questionnaire, as 
described by Zhou et al, includes 12 questions (7 Likert-type questions, 4 yes/no questions, and 
1 open question). For our study, we have adapted this to 9 questions (2 Likert-type questions, 5 
visual analog scales, and 2 yes/no questions) relevant to our study. Our adapted questionnaire 
will address the patients’ overall satisfaction, pain, and comfort with the procedure.  Four of 
the questions in the questionnaire will address satisfaction with the procedure.  A participant is 
considered to be satisfied with the procedure if they did not have any undesirable reactions, 
were comfortable during the procedure, and would be willing to undergo the procedure again. 
 
f) Overall calculation of tolerability 
 
A composite score that will be determined by a) Pain score prior to and immediately 
following the procedure as measured by the 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. The levels of tolerability will be categorized 
as well tolerated, tolerated, and not tolerated. They are defined as the following: 
i. Well tolerated: either pain did not increase more than 18mm on the VAS during or post-
procedure, participants had no serious adverse events, and participants are satisfied 
with the procedure. 
ii. Tolerated: No adverse events and one of: pain did not increase more than 18mm on the 
VAS either during or post-procedure OR participants are satisfied with the procedure  
iii. Not tolerated: Any adverse event OR patients experienced an increase of more than 
18mm on the VAS either during or post-procedure AND participants are not satisfied 
with the procedure 
 


g) Reliability of the Budapest Criteria 
 
Two independent physicians will apply the Budapest clinical criteria to confirm or rule 
out the diagnosis of SHS.  The two physicians will differ in their level of training with the training 
resident being a comparator to the stroke rehabilitation attending physician. Each assessment 
will be done independently and within 24 hours of each other to avoid changes in their clinical 
status. The physicians will not discuss their findings with the patient or each other (double 
blind) as this may lead the second independent assessor to make a similar conclusion.  The 
attending physician independently of the second assessor will have the final decision on patient 
management in order to avoid alterations in standard of care. The evaluations by both the 
resident and attending physician will remain in a sealed opaque envelope in a locked drawer 
managed by our research assistant at EBH until the completion of the study. The evaluation 
forms will carry only the participants study number, and will carry no identifying data. 
Identifying data linked to the study number will be kept in a separate, encrypted electronic 
document on the Ottawa Hospital Server. Statistical assessment will be performed with the 
help of the Ottawa Methods Centre. 
 
 
ENROLLMENT PROCEDURE AND SEQUENCE OF ASSESSMENT. 
 
Enrolment for the study and sequence of assessment will be as follow for each participant: 
a) Referral: Stroke patients with suspected shoulder-hand-syndrome (SHS) are most often 
identified on the inpatient stroke rehabilitation ward at Élisabeth Bruyère Hospital (EBH) 
or Saint Vincent’s Hospital (SVH) in Ottawa, ON. They are occasionally encountered in 
the outpatient stroke clinics at EBH. Patients with suspected SHS will be referred to Dr. 
Campbell (a physical medicine and rehabilitation physician who specializes in stroke 
rehabilitation) for evaluation. This has been discussed with the other physicians at EBH 
or SVH. Such patients most commonly present with a painful shoulder followed by a 
painful edematous hand. Subjects will be recruited over a 12-month period from the in-
patient stroke rehabilitation unit at EBH, the restorative care inpatient program at SVH, 
and the stroke outpatient clinic at EBH.   
b) Screening: Two independent physicians will assess the patient using the Budapest 
clinical criteria. The diagnosis will be placed in a sealed envelope in a locked drawer until 
completion of the study. 
c) Recruitment: the physical medicine and rehabilitation physician will then independently 
decide on patient management and recruitment for peripheral nerve blockade. 
d) Baseline pain: this will be assessed when the participant is enrolled in the study. 
e) Intervention: participants will have the ultrasound guided suprascapular and median 
nerve block within 1 week of diagnosis and recruitment.  
f) Post-procedure survey: will be completed by both the participant and interventional 
radiologist within 1 hour following the procedure. This will include the VAS. 
g) Logbook: a logbook will be given to each participant with an information pamphlet 
regarding the adverse events to monitor for. The participant will record any adeverse 
events over a 2 week period. 


h) 2-week follow up: participants will return their logbooks. They will also complete a final 
VAS. 
  
OUTCOME MEASURES 
 
Objective 1 (Primary outcome): 
Patient tolerability. This will be defined by a composite score determined by: a) the 
difference between the level of pain from before (baseline), during, and 1 hour after the 
procedure as determined by the visual analog scale; b) the rate of serious adverse events 
associated with the procedure; and c) the level of patient acceptance/satisfaction as indicated 
by a validated post-procedural survey.  
A lack of increase of pain of >18mm in the self-assessment test comparing before, 
during and after the procedure will indicate the patient tolerated the procedure. Additionally, 
absence of serious adverse events and participants’ satisfaction with the procedure. 
 
Objective 2 (Secondary outcomes): 
Examiner’s reliability of the Budapest clinical criteria. This will be achieved by 
estimating the level of inter-rater agreement through the intra-class correlation coefficient 
(ICC) and the limits of agreement. We expect a good to excellent inter-rate agreement with an 
ICC of greater than 0.60 (Cicchetti 1994). 
 
Change in pain. The visual analog scale, similar to that in the questionnaire, will be used 
to address the change in pain from baseline (before procedure) to 2 weeks after the procedure. 
 
STATISTICAL ANALYSIS 
 
All statistics will be performed with the assistance of the Ottawa Methods Centre (Dr. 
Rosendo Rodriguez, who assisted us with the development of our protocol). Descriptive 
statistics and plots will characterize the distribution of pain scores obtained at baseline and 
after the procedure for all patients.  Rates, proportions and ratios will describe the distribution 
of patients below and above the pre-determined cut-off.  The cut-off is at least two of the three 
parameters: lack of increase of pain of >18mm post-procedure, no serious adverse events, and 
the patient was satisfied or very satisfied with the procedure. We will use t-tests to assess the 
significance of the differences in pain scores between baseline and each post-procedural 
examination.  In case of substantial skewing of the data, suitable transformations or non-
parametric alternatives will be considered (ie. Mann-Whitney U test).  
Reliability of the Budapest criteria on the diagnosis of SHS will be assessed by intra-class 
correlations or kappa statistics and limits of agreement (95% confidence interval) (Rosner and 
Willet 1998). Bland-Altman’s plots will display the differences in scores between physicians by 
incorporating their mean values (Bland and Altman 1986). 
 
Sample size estimation. Based on our institution’s history of new SHS patients, we 
estimate a rate of 1 to 2 per month, 10% of whom will be limited due to cognition and language 
impairment, we expect to have an average of 12 potentially eligible patients. Since roughly 2/3 


of those are assumed to consent to the procedure, at least 8 to 10 participants are expected to 
enrol in a single year for this study.   
 
ETHICAL ISSUES 
 
 
All participants will receive the standard of care for SHS and will be treated by Dr. 
Campbell.  Additional risks may occur with the addition of peripheral nerve blockade to the 
suprascapular and median nerves, as it is an interventional procedure.  Informing the patients 
of the risks and providing them with a pamphlet on how to identify adverse events will mitigate 
these risks. Additionally, we will provide a contact number for the participants if they have any 
questions regarding symptoms. 
 
FUTURE PLANS 
 
 
This preliminary study addresses a novel treatment for stroke patients with SHS. It will 
provide information on the safety and tolerability of the proposed procedures. The information 
from this study will inform investigators that suprascapular and median nerve blockade is 
tolerable to stroke patients with SHS. One of our secondary outcomes, pain 2 weeks post-
procedure, will also be informative regarding the short-term efficacy in alleviating pain with this 
treatment. We hope to use the data gathered from this study to design a larger study that will 
address the efficacy of this treatment for relieving pain.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Appendix A 
 
Budapest criteria for shoulder hand syndrome (Clinical criteria): 


 
1. Continuing pain, which is disproportionate to any inciting event 
2. Must report at least one symptom in three of the four following categories: 
a. Sensory: Reports of hyperalgesia and/or allodynia 
b. Vasomotor: Reports of temperature asymmetry and/or skin color changes and/or skin 
color asymmetry 
c. Sudomotor/Edema: Reports of edema and/or sweating changes and/or sweating 
asymmetry 
d. Motor/Trophic: Reports of decreased range of motion and/or motor dysfunction 
(weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin) 
3. Must display at least one sign at time of evaluation in two or more of the following categories: 
a. Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or 
deep somatic pressure and/or joint movement) 
b. Vasomotor: Evidence of temperature asymmetry and/or skin color changes and/or 
asymmetry 
c. Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating 
asymmetry 
d. Motor/Trophic: Evidence of decreased range of motion and/or motor dysfunction 
(weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin) 
4. There is no other diagnosis that better explains the signs and symptoms 
(Adopted from Harden 2013) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix B 
 
Study 
Methods 
Results 


Non-pharmacological 
Kondo et al. 2001 
152 stroke patients admitted to a 
rehabilitation unit and followed 
for 200 days were monitored for 
the development of SHS. Half of 
the patients were treated with a 
physical therapy protocol to 
prevent SHS. The remaining 
patients received standard 
inpatient rehabilitation.  
 
Incidences of SHS were 15/81 
(18.5%) for patients receiving 
the protocol and 23/71 (32.4%) 
among patients who did not.  
 
Cacchio et al. 2009 
48 patients with SHS were all 
treated with convention PT and 
randomized into mirror therapy 
group. 
There was significant 
improvement in pain and 
function (p<0.001) in the mirror 
therapy group. 
Pharmacological - Corticosteroids 
Braus et al. 1994 
36 patients with SHS were 
randomized to receive 
methylprednisolone 8mg orally or 
placebo for 4 weeks.  
No improvement was noted in 
placebo group after 4 weeks 
therefore switched to treatment 
group. Those receiving 
corticosteroids significant 
improvement in SHS that was 
maintained at 6 months. 
Kalita et al. 2006 
60 patients with SHS were 
randomized to receive 
prednisolone 40mg orally or 
piroxicam 20mg daily. 
83.3% of the prednisolone group 
had a significant improvement 
compared to 16.7% of the 
piroxicam group. 
Rah et al. 2012 
58 patients with SHS were 
randomized to receive 
triamcinolone 40mg orally or 
lidocaine placebo group. Pain level 
was assessed at 2, 4 and 8 weeks 
post treatment. 
Significant improvement with 
VAS in treatment group 
compared to placebo group at 4 
and 8 weeks (p<0.05). 
Interventional - Sympathetic Ganglion Nerve Block 
Price 1998 
Compared 7 patients with CRPS 
with stellate ganglion (n=4, 15ml 
lidocaine 1%) or lumbar 
sympathetic block (n=3, 10ml 
bupivacaine 0.125%) with normal 
saline. 
No significant difference 
Aydemir 2006 
Compared stellate ganglion 
lidocaine block (10 ml of 1%) plus 
sham stellate ganglion ultrasound 
No significant difference 


block (n = 9) to stellate ganglion 
ultrasound ’block’ (consisting of 
ultrasound delivered non-
invasively over the stellate 
ganglion) plus sham stellate 
ganglion lidocaine block (10 ml of 
saline; n = 9). 
Carroll 2009 
Compared 9 patients with CRPS (7 
completed study) with 
sympathetic block with botulinum 
toxin A (75 units) plus bupivacaine 
(10 ml of 0.5%) with just 
bupivacaine (10 ml of 0.5%) in 
people with complex regional pain 
syndrome (CRPS) of the lower 
extremity. 
Significantly longer duration of 
analgesia in the botulinum toxin 
group (median time to analgesic 
failure 71 days (95% CI 12 to 
253)) compared with 
bupivacaine alone (<10 days, 
95% CI 0 to 12; P < 0.02). 
Meier 2009 
23 patients with lower limb CRPS 
compared lidocaine delivered 
intravenously (1% lidocaine; 0.1 
ml/kg, maximum 6 ml) with 
lidocaine sympathetic block 
(1%lidocaine; 0.1ml/kg, maximum 
6ml) in children with lower limb 
CRPS-I or CRPS-II. In a cross-over 
trial participants received 
intravenous (IV) lidocaine and a 
placebo sympathetic block or a 
lidocaine sympathetic block and 
placebo IV. 
No significant between-group 
differences were observed in 
mean spontaneous pain scores. 
There were no significant 
differences between pre- and 
post intervention spontaneous 
pain scores for either group. 
Toshniwal 2012 
Compared continuous SGB (n = 
18; 280 ml, 0.125% bupivacaine at 
2 mL/hour for seven days) to 
continuous infraclavicular brachial 
plexus block (n = 12; 400 ml, 
0.125% bupivacaine at 5 mL/hour 
for seven days) in people with 
CRPS Type I of the upper 
extremity. 
Significantly lower short-term 
pain scores in favour of the 
group receiving the continuous 
infraclavicular brachial plexus 
block versus the group receiving 
the continuous stellate ganglion 
block. Specifically, at 30 
minutes, 2 hours and 12 hours, 
those receiving the continuous 
brachial plexus block had 
significantly lower intensity of 
pain (0.7, 0.5, and 0.7 
respectively) and 
unpleasantness of pain (0.7, 0.7, 
and 0.8 respectively) scores 


compared with those receiving a 
continuous stellate ganglion 
block (intensity: 3.3, 2.7, 1.9; 
unpleasantness: 3, 2.7, 1.9; all P 
< 0.05). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix C 


 
Study 
Methods 
Results 
Suprascapular nerve block in hemiplegic shoulder pain (HSP) 
Jeon et al. 2014 
30 patients with HSP: 10 in 
SSNB, 10 in intraarticular 
injection, and 10 in 
combined.  All injections 
were US-guided. Maximum 
passive ROM and pain level 
was assessed 
There were significant 
differences in shoulder ROM 
with time (1 hour, 1 week, 
and 1 month after injection). 
There was no difference 
according to injection 
method. Pain was 
significantly decreased until 1 
week after injection. After 1 
month pain was relatively 
increased though remained 
significantly decreased 
compared to pre-injection. 
Adey-Wakeling et al. 2013 
64 patients with HSP were 
assigned to the experimental 
group (SSNB) or placebo 
group (NS injection). 32 
patients were assigned to 
experimental group and 32 
to the placebo group. 
Primary outcome measure 
was VAS. Secondary outcome 
measures were disability and 
quality of life scales. 
Both intervention and control 
groups demonstrated 
decreased pain score.  
Patient that received SSNB 
demonstrated statistically 
significant pain reduction 
compared to control at (1 
week, 4 weeks, and 12 
weeks).  There was no impact 
on secondary outcome 
measures. 
Yasar et al. 2011 
26 patients with HSP were 
randomized into intra-
articular steroid injections 
(n=11) and SSNB (n=15).  
ROM and VAS were 
measured at baseline, 1 hour, 
1 week, and 1 month post 
injection. 
There was significant 
difference in ROM and pain 
in both groups. There was no 
difference between the two 
groups.  
 
 
 
 
 
 
 
 
 


Appendix D 
 
Participant post-procedure questionnaire (adapted from Zhou et al 2006): 
1. Select the phrase that indicates how satisfied or dissatisfied you are with the procedure 
overall: 
a. Very satisfied 
b. Satisfied 
c. Slightly satisfied 
d. Slightly dissatisfied 
e. Dissatisfied 
f. Very dissatisfied 
 
2. Do you have any undesirable reaction resulting from the procedure? 
a. Yes          b.   No        If yes, please explain… 
 
3. On this scale, please mark on the line how much pain you had DURING the procedure. 
 
 
 
 
 
4. On this scale, please mark how uncomfortable (other than pain) you were DURING the 
procedure (0 = very comfortable and 10 = very uncomfortable). 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
5. On this scale, please mark how much pain you were having in your HAND just BEFORE 
the procedure. 
 
 
 
 
6. On this scale, please mark how much pain you were having in your SHOULDER just 
BEFORE the procedure. 
 
 
 
 
7. On this scale, please mark how much pain you are having NOW in your HAND, following 
the procedure. 
 
 
 
 
8. On this scale, please mark how much pain you are having NOW in your SHOULDER, 
0 (No pain) 
10 (Worst 
imaginable pain) 
0 (No pain) 
10 (Worst 
imaginable pain) 
0 (No pain) 
10 (Worst 
imaginable pain) 
0 (No pain) 
10 (Worst 
imaginable pain) 


following the procedure. 
 
 
 
 
9. Assuming that these procedures helped your pain, would you be willing to undergo 
them again, sometime in the future? 
a. Yes       b. No, if not, explain _____________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0 (No pain) 
10 (Worst 
imaginable pain) 


Appendix E 
 
Physician post-procedure questionnaire (adapted from Zhou et al 2006): 
List complications: 
 Seizure 
 Coma 
 Cardiac arrest 
 Hypertension, leading to termination of procedure 
 Hypotension, leading to termination of procedure 
 Tachycardia, leading to termination of procedure 
 Bradycardia, leading to termination of procedure 
 Allergic or anaphylactic reactions 
 Unplanned admission to hospital or ICU 
 Technical difficulty (specify) 
 Other (specify)