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Reprint requests to Seung-Hyun Yoon, MD, PhD, Dept of Physical Medicine and Rehabilitation, Ajou University School of Medicine and Ajou University Hospital, San 5, Wonchon-dong, Yeongtong-gu, Suwon 443-721, Republic of Korea
Three primary and 1 university-affiliated tertiary-care hospitals.
Poststroke HSP patients (N=58) with evidence of rotator cuff disorder.
Participants were randomly assigned to receive ultrasound-guided subacromial injection with triamcinolone 40mg (treatment group, n=29), or lidocaine (placebo group, n=29). After a single injection, participants were followed up for 8 weeks.
Main Outcome Measures
Visual analog scale (VAS) of the average shoulder pain level at day and night (VAS-day/night, the primary outcome measures), Modified Barthel Index, Shoulder Disability Questionnaire (SDQ), and angles of shoulder active range of motion (flexion, abduction, external rotation, and internal rotation) at pretreatment and weeks 2, 4, and 8 posttreatment.
There was no significant difference between the 2 groups in the main outcome measures at pretreatment. Compared with the placebo group, VAS-day/night, SDQ, flexion, external rotation, and internal rotation showed significant improvement in the treatment group.
To our knowledge, this is the first randomized, placebo-controlled study to assess the efficacy of subacromial injection in HSP patients with evidence of rotator cuff disorder. Subacromial corticosteroid injection showed improvement in pain, disability, and active range of motion, and the duration of its efficacy continued up to 8 weeks.
The pathogenesis of HSP is not well known; most investigators believe that multiple factors contribute to HSP. Postulated causes of HSP include adhesive capsulitis, rotator cuff disorder, bicipital tendonitis, glenohumeral subluxation, complex regional pain syndrome, spasticity, myofascial pain, central neuropathic pain, and brachial plexopathy.
Because of the various causes and multiple factors involved in HSP, it is not easy to treat the pain. There is also a burden on the time and cost of the treatment. And many times, the result is not satisfactory even after treatment.
which used magnetic resonance imaging, found 35% of the subjects exhibiting a tear of at least 1 rotator cuff, bicep, or deltoid muscle, and 53% exhibiting tendinopathy of at least 1 rotator cuff, bicep, or deltoid muscle. Normally, the rotator cuff muscle puts downward pressure on the humerus head during the shoulder joint abduction and flexion. But in patients with hemiplegia, the weakened rotator cuff makes it difficult to put a smooth downward pressure on the humerus head, and this leads to impingements. It is presumed that frequent impingements in turn lead to repeated microtraumas and inflammatory responses, resulting in tendinitis or tendon tear.
Corticosteroid injection is frequently performed in patients with HSP; however, it is still controversial when it comes to its efficacy. One study reported improvements in the range of motion and pain of hemiplegic patients after intra-articular corticosteroid injection.
which categorized the cause of shoulder pain into 2 groups, the adhesive capsulitis or subacromial impingement group, and administered an intra-articular or subacromial injection, respectively. According to the study results, both groups showed an increased range of motion and reduced pain. But this study was not blinded and also lacked a placebo control.
There is a paucity of study on the efficacy of subacromial corticosteroid injection, and no randomized controlled trial exists to draw any conclusions. We performed a subacromial injection on stroke survivors with hemiplegia who were dignosed with rotator cuff disorder as one of the major causes of shoulder pain. We hypothesized that subacromial corticosteroid injection would have a positive effect on pain, range of motion, disability, and activities of daily living.
Between October 2009 and July 2010, eligible participants with shoulder pain were recruited in the rehabilitation and neurosurgery clinics of a university hospital in Suwon City, South Korea and 3 other local clinics in Suwon, Goyang, and Busan City. Demographics of the participants, including age, sex, etiology, time since stroke, affected side, Brunnstrom stage of upper limb, and presence of spasticity, were recorded.
Inclusion and Exclusion Criteria
Inclusion criteria were: (1) hemiplegia after stroke, (2) HSP of at least 1 month in duration, (3) aged 20 to 70 years old, (4) clinically and ultrasonographically diagnosed rotator cuff disorder; a minimum of 1 positive finding from the physical tests showing correlation with the ultrasonographic evaluation, (5) pain defined as a score of 3 points or more on a 10-cm visual analog scale (VAS) rated from 0 (no pain) to 10 (worst imaginable pain), (6) muscle power of deltoid grade 2 (poor) or greater on the manual muscle test by the Medical Research Council Scale, and (7) a minimum score of 20 points for the Mini-Mental State Examination to ensure the patient can make his/her own decision to participate in the research and express changes in pain.
Exclusion criteria were: (1) current adhesive capsulitis (restriction of passive motion >30° in ≥2 planes of movement, measured to onset of pain with a gravity inclinometer),
grade 3 (considerable increase in muscle tone, passive movement difficult) and 4 (rigid in flexion or extension) in affected upper limb, (6) shoulder subluxation (the width between the inferior aspect of the acromion and the superior aspect of the head of the humerus >1 finger at a sitting or standing position without supporting the affected upper limb),
(7) severe motor weakness (muscle power of deltoid less than grade 2 on the manual muscle test), (8) primary osteoarthritis of glenohumeral joint in a simple radiograph, (9) the presence of another obvious explanation for the pain (ie, fracture, radiculopathy, myofascial pain, central neuropathic pain), (10) the presence of an unstable medical condition or a known uncontrolled systemic disease, including cancer, rheumatoid arthritis, endocrine disease, major depression, or schizophrenia, (11) previous trauma history of the currently affected shoulder, (12) evidence of recent alcohol or drug abuse, (13) previous corticosteroid injection history of the affected shoulder, or (14) incapable of communication owing to severe aphasia. To prevent postinjection hemorrhage, we did not include participants who were currently taking medication such as an antiplatelet agent or anticoagulation, with the exception of those who agreed to stop for a minimum of 5 days before the injection.
A power analysis programa was used to calculate the number of participants.
Mean pain intensity scores (0–5 scale; 0=worst) of the subacromial injection (40mg triamcinolone and lidocaine) and placebo (lidocaine only) groups in this study were 4.04 and 3.00, respectively, and the SD was 1.55. For alpha of .05 (2-tailed test), 80% power, 2 groups, and 3 repetitions, 52 participants were required. A total of 60 participants would be necessary to allow for 15% loss to follow-up. At the final analysis, 58 participants were included, with an analysis power of 86%. The study was approved by the institutional review board at the university hospital, and all participants gave their written informed consent.
Diagnosis of Rotator Cuff Disorder
To determine rotator cuff disorders, we examined physical and ultrasonographic evaluations. We checked for muscle power of rotator cuff and tenderness in the affected shoulder. The Neer,
Participants with no positive findings in these tests were excluded.
After the physical tests, participants were examined with commercial, real-time ultrasound equipment (Logiq P6,b Accuvix XQ,c SonoAce X8,c HD 11XEd) using 5- to 13-MHz linear-array transducers. The examiners evaluated the participants for the presence of a rotator cuff impingement/tendinopathy/tear, calcification, subacromial bursa fluid, or abnormalities of the long head of the biceps tendon. Decisions regarding the imaging interpretations were based on the finding of previously published studies.
The subacromial bursitis was defined as hypoechogenic fluid filled bursa greater than 2-mm thick. Dynamic examination by moving the arm from neutral position to abduction was performed to evaluate impingement syndrome.
Design and Randomization
This study was a multicenter, randomized, triple-blind (the participants, injection operators, and evaluators), placebo-controlled trial. A schematic of the study is shown in figure 1. A total of 181 participants were recruited. Of them, 121 were excluded. After screening evaluations, 60 participants were randomly assigned to 1 of 2 groups by a block randomization method, which ensured that approximately equal numbers were allocated to each group.
A computerized random number generator and table were used to perform group allocations, which were managed by an assistant (other than the authors). Four of the authors who are board certified physiatrists (S.H.Y., J.Y.H., D.J.M., and B.J.) with 5 to 10 years of experience in ultrasonographic evaluation; evaluators and the musculoskeletal radiologist (K.S.K.) attended a 2-day training course on the study procedure, physical tests, home exercise program, and ultrasonography for diagnosis and injection procedure. The investigators adhered to the injection protocol even after the training course. One of the authors (J.Y.H.) in the university hospital visited the local clinics to facilitate communication between the medical personnel and minimize the differences in diagnoses due to the use of ultrasonography. Clinical investigator meetings were also held once a month, on average.
After physical and ultrasonographic examination, the participants were randomized to have either a single injection of 4mL of 40mg (10mg/mL) triamcinolone acetonide and 1mL of 1% lidocaine or 5mL of 1% lidocaine. The injection was prepared by a sterile technique using opaque syringes so that the participants, injection operators, and evaluators remained blinded to the group assignment. Participants sat in an upright position and the arms were positioned behind their backs with internal rotation and hyperextension of the shoulder and with the elbow bent for longitudinal supraspinatus view. A 23-gauge, 6-cm long needle was inserted parallel to the transducer in a semioblique plane from the posterior side of the shoulder (fig 2) . The needle was advanced with real-time ultrasound equipment until the needle tip entered the bursa.
Participants had to stay at the hospitals for more than 20 minutes after the injection for any signs of acute adverse reactions. Late adverse reactions including postinjection flare, disturbance of menstrual pattern, facial flushing, subcutaneous tissue atrophy, skin depigmentation, infection, and tendon rupture were also checked at each follow-up. Patients on analgesics, if any, were told to stop administering from 5 days before the injection.
Because corticosteroid injection may lead to a temporary weakening of the tendon,
participants were given instructions to avoid any heavy work or exercises on the shoulders for the first 2 weeks after the injection. Although systematic reviews of interventions for rotator cuff disorder and shoulder pain suggest that exercise can be an effective treatment,
which synthesized features of exercise protocols from clinical studies with the highest levels of evidence. When participants revisited the hospital for a follow-up evaluation at week 2 postinjection, evaluators handed out picture leaflets and provided an education on home exercise programs based on the adopted protocol. Recommendations to keep exercising were also given at each follow-up examination. Participants were also encouraged to write an exercise diary to record the exercise frequency, duration, and any difficulties. These diaries were reviewed at each follow-up visit. Participants with low compliance were contacted by phone and encouraged to continue exercising. From week 2, participants were instructed to start gentle and active range of motion (AROM) exercise without weight. From week 3, they were told to perform progressive strengthening exercises for the scapular stabilizing muscles; from week 4, they were told to perform rotator cuff strengthening with closed chain exercises. Exercises were to be performed 3 times a day lasting 10 minutes each round, and participants were to continue until they felt pain or the pain was no longer bearable to continue exercising. They were also prohibited from taking any additional medication and physical modalities, such as heat, cold, and electricity.
Treatment efficacy was evaluated at pretreatment and weeks 2, 4, and 8 after the injection by the 4 evaluators who were not informed of the injected medication. Primary outcome measure was 10-cm VAS for shoulder pain intensity during the day (VAS-day) and the night (VAS-night). The participant answered the question: “with respect to the worst pain you have experienced in your life, what was the average level of your shoulder pain in the last one week?” by placing a mark somewhere along the line. Secondary outcome measures were AROM of the shoulder, the Korean version of the Modified Barthel Index,
AROM was measured by a goniometer for forward flexion, abduction, and external rotation of shoulder. The measurement was taken in a position not affected by gravity (flexion measured lying on the side of the unaffected limb, abduction in a supine position, and external rotation in a sitting position). Participants were asked to move their shoulders slowly and the angle on onset of pain was measured 3 times to record the average value. Scapular rotation was prevented by the evaluators' hand. External rotation was measured in 0° abduction of shoulder and 90° flexion of elbow position. Internal rotation was measured from the vertebra prominens at C7 to the tip of the fully extended thumb. The distance (cm) from the spinous process of C7 vertebra to the tip of the actively extended thumb on the back was measured using a measuring tape.
and is a useful method that is also relevant with the activities of daily living, such as dressing, bathing, and toileting. The functional level was evaluated with the Modified Barthel Index, composed of 10 criteria (personal hygiene, bathing, feeding, toileting, stair up/down, dressing, defecation, voiding, ambulation, and chair/bed transfer) on a scale of 0 to 100. An SDQ score is commonly used in the evaluation of shoulder disability in clinical trials, has proven levels of validity, and consists of 22 self-reporting items that participants respond to with either yes or no. The SDQ has demonstrated strong associations with quality of life measures and compares favorably with other published shoulder disability questionnaires in terms of overall validity and patient acceptability. The score ranges between 0 (no disability) and 22 (maximal disability).
Comparisons of baseline characteristics of participants were based on the chi-square and Mann-Whitney U test. The effect of subacromial injection (treatment or placebo) was evaluated with repeated-measures analysis of variance (ANOVA). If the repeated-measures ANOVA for group by time interaction was significant, post hoc tests with Bonferroni correction was conducted to compare the 2 groups at each time point. Significance was accepted for P values of less than .05. Statistical analyses were performed by SPSS statistical software.e
A total of 60 patients were recruited and of them, 2 were excluded from further follow-ups: 1 from the placebo group who claimed no effect from the injection and the other from the treatment group who cited difficulties of transportation as the reason for no longer visiting the hospital (see fig 1). Table 1 shows the baseline characteristics of the study participants and the ultrasonographic findings of affected shoulder. With the exceptions of hemiplegic side and the ultrasonographic finding of increased fluid in the biceps tendon sheath, there was no significant difference between the treatment group and placebo group in age, sex, stroke type, duration of stroke, duration of shoulder pain, Brunnstrom stages, and Modified Ashworth Scale. There was no significant difference between the treatment group and placebo group in VAS-day, VAS-night, SDQ, Modified Barthel Index, and AROM at pretreatment (P>.05). Changes in outcome measurements after subacromial injection are shown in table 2. Repeated-measures ANOVA showed significant effect of time in all outcomes measures (VAS-day, F2.01,112.35=30.93, P<.001; VAS-night: F2.04,114.49=33.42, P<.001; SDQ, F1.73,97.11=37.41, P<.001; Modified Barthel Index, F1.11,61.91=6.50, P=.011; flexion, F1.71,95.98=28.31, P<.001; abduction, F1.33,74.33=12.66, P<.001; external rotation, F1.72,96.30=14.63, P<.001; internal rotation, F1.56,87.56=8.99, P=.001), and significant group by time interactions for VAS-day (F2.02,112.35=7.67, P=.001), VAS-night (F2.04,114.49=8.91, P<.001), SDQ (F1.73,97.11=15.20, P<.001), flexion (F1.71,95.98=28.10, P<.001), external rotation (F1.72,96.30=8.67, P=.001), and internal rotation (F1.564,87.564=11.15, P<.001). This means that compared with pretreatment, all outcome measures improved significantly in both groups by time. Compared with the placebo group, VAS-day/VAS-night, SDQ, flexion, external rotation, and internal rotation showed significant improvement in the treatment group. Post hoc tests for between-group comparison revealed that of VAS-day at weeks 4 and 8, VAS-night at weeks 2, 4, and 8, SDQ at weeks 4 and 8, flexion at weeks 2, 4, and 8, and external rotation at weeks 2 and 4 showed significant improved in the treatment group.
There were no important complications, such as skin pigmentation or infection, other than facial flushing on days 1 to 5 after injection (2 participants in treatment group) and dizziness due to vasovagal reaction during injection (1 participant in placebo group).
Subacromial injection with corticosteroid is known to improve pain and function in nonstroke patients with rotator cuff disorder.
However, there is a paucity of studies on the efficacy of subacromial injection in stroke patients with rotator cuff disorder. Although there are a few studies that report improvements in the range of motion and pain after subacromial injection,
it is still difficult to assess the efficacy because they either lack the number of participants, placebo control, or have the problem of an unblinded study design. This study was designed to complement previous studies; to our knowledge, this is the first randomized, placebo-controlled study to assess the efficacy of subacromial injection in poststroke HSP.
Intra-articular and subacromial injections with corticosteroid are frequently used procedures in poststroke HSP but not enough evidence exists to prove its efficacy. A randomized trial
on the efficacy of intra-articular injection in HSP reported no improvement in pain and therefore did not recommend intra-articular injection. However, we believe the one-size-fits-all use of intra-articular injection on all HSP, without taking into consideration their various causes such as adhesive capsulitis, rotator cuff disorder, glenohumeral subluxation, complex regional pain syndrome, spasticity, and neuropathic pain, may have led to such result. Subsequent studies
suggested the possibility of subacromial injection to HSP patients with evidence of rotator cuff disorder having a positive effect on pain and function. These suggestions were even more clearly confirmed by our study.
The minimum clinically significant change of VAS pain severity is known to range from 1.3 to 3.0.
In several studies that used a subacromial injection of triamcinolone 40mg (the same dose as our study) to nonstroke subjects with rotator cuff disorders, the change from baseline VAS score was −3.6±2.9 and −3.5±2.9 at weeks 4 and 8, respectively,
and in our study, −1.9±1.6 and −2.5±1.4 at weeks 4 and 8, respectively. This suggests that the subacromial injection may be less efficacious for stroke survivors than nonstroke patients in relieving pain. It is generally known that the pain is relieved due to the corticosteroid that reduces the inflammation of the rotator cuff.
But as mentioned earlier, various causes are involved in patients with HSP. It can be assumed, then, that anti-inflammatory property alone does not suffice for relieving pain in HSP patients.
We used the Modified Barthel Index to find out whether the improvement in shoulder pain and AROM after the subacromial injection had an effect on the activities of daily living. Despite improvements in pain and AROM for treatment groups at week 8, there was no significant difference in the Modified Barthel Index between the 2 groups. This is probably because the Modified Barthel Index is not a test that is designed specifically for shoulders. For instance, it includes many items that have more to do with the functions of distal than proximal upper limbs, and functions that have little to do with upper limbs, such as toileting, stair up/down, defecation, voiding, and ambulation.
First, in the case of stroke patients, it is difficult to diagnose the rotator cuff disorder accurately using a physical test due to the motor weakness of their hemiplegic limb. Studies on the correlation between a physical test and the ultrasonographic finding in diagnosing rotator cuff disorder in nonstroke subjects found the accuracy to be lower when a physical test alone was used for diagnosis, and therefore emphasized the added use of ultrasonographic evaluation for enhanced accuracy.
Based on these studies, we included participants only if a positive finding of rotator cuff disorder using the physical test correlated with those of the ultrasonographic evaluations. Still, there is (1) no standard criteria for diagnosing the rotator cuff disorder of poststroke HSP patients, (2) no evidence that the correlation of physical and ultrasonographic examination will improve the diagnostic accuracy of rotator cuff disorder in poststroke HSP patients, and (3) no way to figure out whether the discovered rotator cuff disorder is the cause of the current HSP because there is no knowledge about the prior shoulder anatomy. All these points may lead to a selection bias of this study.
Second, although we tried to include HSP patients diagnosed only with rotator cuff disorder, those with other causes may have been included. For instance, clinical diagnosis criterion of the International Association for the Study of Pain
was used to diagnose the complex regional pain syndrome, without 3-phase bone scan. This criterion is not always clear and may lead to inaccurate diagnosis. Also, while excluding the severe spasticity patients of grade 3 and beyond on the Modified Ashworth Scale from the study, we did not exclude less severe patients because most stroke patients have spasticity and cannot be entirely excluded.
longer-term effect of subacromial injection of about 6 or 12 months should be studied.
Lastly, it is difficult to generalize because we excluded patients with severe motor weakness, or muscle power of deltoid less than grade 2, and those with subluxation. These are stroke patients with the highest risk and prevalence of HSP. And because these conditions are common in patients with HSP, excluding such patients would pose as a certain limitation.
To our knowledge, this is the first randomized, placebo-controlled study to assess the efficacy of subacromial corticosteroid injection in HSP patients with evidence of rotator cuff disorder. Subacromial injection showed improvement in shoulder pain, disability, and AROM; the duration of its efficacy continued up to 8 weeks after the single injection without serious complications. This study shows how subacromial injection can be an efficacious treatment for patients with HSP.
Supported by the Department of Medical Sciences, The Graduate School, Ajou University (grant no. 3-2009-0090) .
No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.