(Stroke. 2000;31:2396.)
© 2000 American Heart Association, Inc.
Original Contributions |
Effect of Triamcinolone Acetonide Injections on Hemiplegic Shoulder Pain
A Randomized Clinical Trial
From the Department of Rehabilitation Medicine, University Hospital, Vrije Universiteit, Amsterdam (I.A.K.S., H.B., G.J.L.); Institute for Research in Extramural Medicine, Vrije Universiteit, Amsterdam (I.A.K.S., H.B., G.J.L., J.W.R.T., L.M.B.); Department of Rehabilitation Medicine, Jan van Breemen Instituut, Amsterdam (J.H.M.D.); Rehabilitation Center Heliomare, Wijk aan Zee (P. de K.); and Rehabilitation Center Amsterdam (P.A.K.) (Netherlands).
Correspondence to I.A.K. Snels, Department of Rehabilitation Medicine, University Hospital, Vrije Universiteit, PO Box 7057, 1007 MB Amsterdam, Netherlands. E-mail reva{at}azvu.nl
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Abstract |
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Background and Purpose—Hemiplegic shoulder pain is not uncommon after stroke. Its origin is still unknown, and although many different methods of treatment are applied, none have yet been proved to be effective. We sought to study the efficacy of 3 injections of intra-articular triamcinolone acetonide on pain and arm function in stroke patients with hemiplegic shoulder pain.
Methods—In a multicenter, randomized, placebo-controlled clinical trial, patients with hemiplegic shoulder pain received either 3 intra-articular injections of 40 mg triamcinolone acetonide or 1 mL physiological saline solution (placebo). Primary outcomes were pain measured according to 3 visual analogue scales (score range, 0 to 10), and arm function was measured by means of the Action Research Arm test and the Fugl-Meyer assessment scale; secondary outcomes were passive external rotation of the shoulder and general functioning measured according to Barthel Index and the Rehabilitation Activities Profile.
Results—In the triamcinolone group (n=18), the median decrease in pain, 3 weeks after the last injection, was 2.3 (interquartile range, 0.3 to 4.3) versus 0.2 (interquartile range, -0.5 to 2.2) in the placebo group. This result was not statistically significant. The change in the other outcome measures did not differ significantly between the 2 treatment groups. Twenty-five patients reported side effects.
Conclusions—In the 37 participants included in this study, triamcinolone injections seemed to decrease hemiplegic shoulder pain and to accelerate recovery, but this effect was not statistically significant. Therefore, on the basis of the results of this study, these injections cannot be recommended for the treatment of patients with hemiplegic shoulder pain.
Key Words: clinical trials • hemiplegia • shoulder pain • stroke • triamcinolone
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Introduction |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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The occurrence of hemiplegic shoulder pain varies from 16% to 84% in stroke patients.1 2 3 4 5 6 7 8 These patients remain hospitalized for a longer period of time, and shoulder pain interferes with the rehabilitation process.6 8 Many different methods of treatment are applied for hemiplegic shoulder pain,2 9 10 and many different preventive measures are also recommended.2 6 7 11 12 13 14
The clinical presentation of hemiplegic shoulder pain mimics that of the frozen shoulder (adhesive capsulitis). Recently, 2 reviews on the effectiveness of corticosteroid injections for shoulder disorders (in nonhemiplegics) have been published. Van der Heijden et al15 found some indications for a positive effect of steroid injections for shoulder disorders, while Green et al16 concluded that these injections improve the abduction in patients with rotator cuff tendinitis, but that no conclusion can be drawn about their effectiveness for patients with a frozen shoulder. However, in clinical practice, physiatrists frequently treat patients with hemiplegic shoulder pain with steroid injections.10 In a small, uncontrolled study, Dekker et al17 found a positive effect of 3 intra-articular injections with triamcinolone acetonide (a corticosteroid) in 5 of 9 stroke patients with hemiplegic shoulder pain. However, the question of whether these injections are more effective than placebo injections remains unsolved. Therefore, a randomized clinical trial was conducted to evaluate the effect on pain and arm function of 3 intra-articular injections of triamcinolone acetonide versus placebo injections in patients with hemiplegic shoulder pain after stroke.
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Subjects and Methods |
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Design
In a multicenter, placebo-controlled clinical trial, patients were randomized into 2 groups on the basis of computerized random numbers. Four strata were defined: rehabilitation centers versus nursing homes and onset of stroke shorter or longer than 6 months before the trial. For the treatment allocation, numbered sealed envelopes were used. Patients received either 3 injections with triamcinolone acetonide (40 mg Kenacort A-40 in 1 mL) or 3 placebo injections (1 mL saline solution). The patients and all other people involved, except for the injecting physicians, were blinded for the type of treatment. Although an attempt was also made to blind the injecting physicians, this was not possible. Therefore, in no case was an injection given by the physiatrist who was treating the patient. One week before treatment commenced only pain was measured, and 1 week later all baseline measurements were performed, followed by randomization and the first injection. The third measurement took place 1 week after baseline, immediately before the second injection. Two weeks after the second injection the fourth measurement took place, immediately before the third injection. The follow-up measurements took place 3 and 9 weeks after the third injection.
Subjects
Inclusion criteria were as follows: (1) hemiplegia after
stroke, (2) pain in the hemiplegic shoulder 
4.0 (on a scale of 0
to 10) on at least 1 of 3 visual analogue scales (VAS) during at least
2 weeks, (3) a limitation of the passive external rotation of the
hemiplegic shoulder of >20° compared with the other (unaffected)
side, (4) age 18 to 80 years, and (5) written informed consent. The
most important reasons for exclusion were an injection in the affected
shoulder during the previous 6 months or use of systemic
corticosteroids during the previous 3 months, other
obvious explanation for the pain (eg, fracture, luxation), earlier
surgery of the involved shoulder, severe communication problems (<P50
on the Stichting Afasie Nederland test),18 or severe
cognitive problems (
20 on the Mini-Mental State
Examination).19 Patients were initially recruited from 2
rehabilitation centers, but after 6 months, an insufficient number of
patients had been included. Therefore, patients were recruited from 4
additional rehabilitation centers, the rehabilitation wards of 3
nursing homes, and a stroke patient organization. The research protocol
was approved by the ethics committees of all participating
institutions.
Treatment
The injections were given by experienced physicians via the
posterior route.20 After each injection the patients were
provided with a sling for the rest of the day, but no further changes
were made in their normal rehabilitation program.
Measurements
Baseline Measures
In addition to demographic and medical characteristics (type of
stroke, side of lesion in the cerebrum, side of hemiplegia,
comorbidity), the following prognostic factors were measured at
baseline. The grade of subluxation of the shoulder was rated from an
x-ray film of the affected shoulder in an anteroposterior
projection, as described by Van Langenberghe and
Hogan.21 Sensory disorders were dichotomized: any sensory
deviation reported by the patient in a test involving touching or
pin-pricking of the arms, or in a test for vibration disorders with a
tuning fork on the distal end of the radius, was rated as abnormal.
Visual field deficits were tested by means of the direct confrontation
method.22 Neglect was measured according to a letter
cancellation test and a line bisection test and was defined as the
difference between right and left of >2 missed O’s on a
letter cancellation test or <34 O’s canceled of 40, or a
mean deviation of >+7.9 mm for neglect of the left side or
>-6.1 mm for neglect of the right side on a line bisection test
that consisted of 10 lines of 10 cm. Similar tests are described
elsewhere.23 24 Spasticity was assessed during
passive motion in the elbow joint and rated according to the Ashworth
scale.25 The presence or absence of a shoulder-hand
syndrome was rated according to the criteria of Tepperman et
al.26
Primary Outcome Measures
Pain was measured according to 3 vertical VASs of 10.0 cm each:
pain today, pain during the day in the previous week, and pain during
the night in the previous week.27 28 The bottom of the
scale was no pain at all, and the top was very severe pain. The outcome
measure was calculated as the mean of the pain scores during the day
and during the night in the previous week. The arm function was
assessed by means of the Action Research Arm test,29 30
which consists of 19 items focusing on grasping objects of different
shapes and sizes and gross movements of the arm (score range, 0 to 57).
The Fugl-Meyer assessment scale for the upper extremity and
coordination (32 items; score range, 0 to 66) was used to assess the
impairment level of the arm function.31 In both the Action
Research Arm test and the Fugl-Meyer assessment scale, a higher score
indicates a higher functional level.
Secondary Outcome Measures
The passive range of external rotation of the shoulder was
measured with a fluid-filled goniometer.32 The functional
level of the patients was measured according to the Barthel
Index33 (10 items; score range, 0 to 20) and 4 domains of
the Rehabilitation Activities Profile: communication, mobility,
personal care, and occupation.34 The Rehabilitation
Activities Profile score was calculated as the percentage of the
maximum possible score for each patient. For both the Barthel Index and
the Rehabilitation Activities Profile, a higher score indicates a lower
functional level. After each injection, the injecting physicians were
asked how sure they were that the injection was intra-articular. All
cointerventions and side effects were recorded.
Statistical Analysis
The greatest difference between the 2 treatment groups was
expected to be found between baseline and the first follow-up, which
took place after 3 weeks. Therefore, for every patient the absolute
change in the outcome scores between baseline and the first follow-up
measurement was calculated, so that a positive difference indicated
improvement for the patient. Because of the small number of patients in
both groups and the skewed distribution of the differences between the
2 groups, a nonparametric test (Mann-Whitney U
test) was used, with the exact method used to calculate the
P values. The level of statistical significance was set at
0.05. Median differences between the groups and the 95% CIs were
calculated.35
Additional analyses were applied to identify specific subgroups in which the results differed from the overall results. These subgroups were based on sex, type of lesion, side of hemiplegia, involvement of the dominant side, time since onset of stroke, time since onset of hemiplegic shoulder pain, recruitment source, sensory disorders, visual field deficits, neglect, spasticity, cointerventions, and comorbidity. SPPS 9.0 for Windows 95 was used for these analyses.
A DOS version of Spida was used to calculate the Generalized Estimating Equations (GEE) for repeated measures in an additional analysis, with the mean pain during the previous week as outcome. Interaction between the treatment group and time was also studied. The advantage of GEE is that the data of all 6 measurements are included. However, with a small number of patients the point estimator becomes less reliable.
A priori, the minimal clinically important difference (MCID) between
the treatment groups were defined as follows: for pain, the MCID was a
decrease of 30% in the total range of the scale on the VAS for pain
during the previous week; for the Action Research Arm test, Fugl-Meyer
assessment scale, and Rehabilitation Activities Profile, the MCID was a
difference of 10% in the total range of the scale; for the Barthel
Index, the MCID was a difference of 4 points of
20.33
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Results |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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Figure 1
shows that 37 patients were
randomized. Twenty-seven patients were recruited from 6 rehabilitation
centers, 8 from 3 nursing homes, and 2 from a stroke patient
organization. Two patients in the triamcinolone group did not receive
the third injection but completed the follow-up measurements. In the
placebo group, 2 patients dropped out because the injections had
insufficient effect: 1 after 2 injections and the other after 3
injections.
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Table 1 shows the baseline
characteristics of the included patients. Despite randomization, sex
and side of lesion were not equally distributed over the 2 groups. None
of the patients suffered from a shoulder-hand syndrome. No differences
were found in the use of preventive measures (supportive sling, lap
board) or in the number of patients who received additional
physiotherapy or occupational therapy for their shoulder. At baseline
the groups did not differ with regard to the outcome variables
(Table 2). Because of logistic problems,
the x-ray films, which were taken to evaluate the degree of
subluxation, were of insufficient quantity and quality, and therefore
this variable could not be included.
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The course of pain over time is presented in Figure 2. In none of the measurements did the
pain scores differ significantly between the groups. The use of GEE
also showed no significant difference between the 2 treatment groups.
The distributions of the other primary outcomes were too skewed to
warrant application of GEE.
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Table 3 shows the results of the
nonparametric tests for all outcome measures. No
significant or clinically relevant differences between the 2 groups
were found.
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In the subgroups of patients with no sensory disorders, pain decreased by 3.6 in the triamcinolone group and by 0.3 in the placebo group (median difference, 2.7; 95% CI, 0.6 to 5.1). In patients with no visual field deficits, pain decreased by 3.0 in the triamcinolone group and increased by 0.1 in the placebo group (median difference, 2.3; 95% CI, 0.3 to 4.4) and in patients with no neglect pain decreased by 3.3 in the triamcinolone group versus 0.5 in the placebo group (median difference, 2.2; 95% CI, 0.1 to 4.4). In other subgroup analyses, however, some significant differences with no biologically plausible explanation were found (data available from the author on request). For the secondary outcome measures (passive external rotation of the shoulder, Barthel Index, Rehabilitation Activities Profile), no significant differences were found.
The results concerning correct placement of the injections are
presented in Table 4. According
to the injecting physicians, 51% of the triamcinolone injections were
certainly intra-articular versus 30% of the placebo injections. This
difference of 21% is statistically significant (95% CI, 3% to
40%).
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After the last measurement, the blinded outcome assessor guessed the applied treatment correctly in 21 of 35 cases (60%): 11 of 17 cases (65%) of the placebo group and 10 of 18 cases (56%) of the triamcinolone group.
Twenty-five patients reported 1 or more side effects: 12 of these
patients were treated with triamcinolone injections and 13 with placebo
injections. Table 5 presents the
reported side effects. In the patients with diabetes, no
disturbances of the blood glucose level were detected.
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Discussion |
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Before recruitment commenced, it was calculated that at least 35 patients in each group would be needed to obtain sufficient power to detect a statistically significant and clinically relevant reduction in pain. A power calculation based on the available data36 revealed a power of 0.5 for detecting the predefined minimum clinically relevant difference in pain improvement. Therefore, the small number of patients included in the study may be the main reason why the effect of the intervention on pain was not statistically significant. The recruitment of patients from various sources may have diluted the results in 2 different ways. First, recruitment of patients from various sources probably introduced additional factors that could have interfered with the experimental treatment but could not be controlled for. Second, the increase in the number of recruitment sources also increased the number of injecting physicians (in total, 16 different physicians were involved).
The effect of intra-articular injections was studied, and the reported
number of intra-articular injections given differed in the 2 groups
(Table 4
). Although it has been reported that intra-articular
corticosteroid injections are more effective than
non–intra-articular injections,37 the clinical importance
of this finding is unclear.38 Therefore, it can be assumed
that this difference between the groups did not influence the outcomes
of the study.
To measure pain, 3 VASs were used: pain today, pain during the day in
the previous week, and pain during the night in the previous week.
Patients were included if they rated their pain 4.0 on 1 of these 3
scales at the first and second measurements. The effect of the
intervention was based on the mean pain score during the previous week.
There was no difference in effect between the 13 patients who rated
their mean pain during last week <4.0 and the 24 who rated their pain
4.0. Although the VAS is a generally accepted and validated
instrument to measure pain and other subjective
feelings,27 39 40 41 several researchers have recently
reported problems when applying a VAS to stroke
patients.42 43 44 These findings were confirmed in the
present study: several patients had serious problems with
understanding the VAS and how to complete it. However, an additional
question about pain, which could easily be answered by the patients,
revealed similar results (data not shown).
Pain in the shoulder and limitation of the passive movements of the shoulder, especially of the external rotation, are the clinical signs on which the diagnosis of capsulitis of the shoulder is based.45 However, pain and a limitation of the external rotation of the shoulder are sometimes attributed to spasticity of the shoulder muscles.3 6 7 13 When spasticity is the main cause of pain, it is unlikely that triamcinolone will have a significant effect. It is difficult to distinguish between pain in the limited hemiplegic shoulder based on capsulitis alone, pain based on spasticity alone, or a combination of these.
Recurrent injuries allegedly maintain a capsulitis.46 47 Patients with sensory disorders, visual field deficits, or neglect have a higher risk of recurrent injuries of the shoulder, possibly resulting in capsulitis, and triamcinolone injections will not resolve this problem. The subgroup analyses in this study seem to confirm this hypothesis, but the number of patients in these subgroups was very small, and therefore no firm conclusions can be drawn.
The absolute change scores were used as an outcome measure. Statisticians disagree on whether it is preferable to use relative change scores48 or absolute change scores.49 However, there is agreement that an absolute outcome without correction for baseline differences would not be appropriate. In this study analysis was performed with both absolute and relative change scores, and similar results were found. Because absolute change scores are more easily interpreted, these are presented.
It was very surprising that it was so difficult to find patients with hemiplegic shoulder pain, which suggests that the occurrence rates reported in the literature should be reexamined. In recent years much emphasis has been placed on the prevention of hemiplegic shoulder pain in the Netherlands, and it seems that the problem is becoming less common. However, if a patient develops hemiplegic shoulder pain, the question of the manner of treatment remains unanswered. No significant effect of triamcinolone injections was found, and side effects were frequently reported (although most of these were not serious). A new and larger randomized trial should be executed to draw definite conclusions about the efficacy of triamcinolone injections and to identify subgroups of patients for whom these injections are effective. However, on the basis of the results of this study, intra-articular triamcinolone injections cannot be recommended for the treatment of hemiplegic shoulder pain.
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Acknowledgments |
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This research project was funded by the Netherlands Organization for Scientific Research, Council for Medical and Health Research (NWO-MW). We are very grateful for the compliance of the patients who participated in this study. We also thank the physicians who introduced the executive investigator to the patients and the physicians who gave the injections.
Received May 10, 2000; revision received June 23, 2000; accepted June 23, 2000.
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