Efficacies of corticosteroid injem

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Level of evidence: Level II, Randomized Controlled Trial, Treatment Study.

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return to daily activities. A single corticosteroid injection isviewed as a conservative treatment modality that achievesgood clinical outcomes.2,11,15 Corticosteroid injectiontherapy has been advised in cases of adhesive capsulitisbecause it is believed that inflammation plays an important

Institutional review board approval: This article was approved by Ewha

Womans University Institutional Board Review (No. ECT 12-04B-41).

*Reprint requests: Sang-Jin Shin, MD, PhD, Department of Orthopaedic

Surgery,School ofMedicine,EwhaWomansUniversity, 1071Anyangcheon-ro,

Yangcheon-Ku, 158-710 Seoul, South Korea.

E-mail addre

J Shoulder Elbow Surg (2012)-, 1-7

1058-2746/$ - s

http://dx.doi.orgss: sjshin622@ewha.ac.kr (S.-J. Shin).Adhesive capsulitis traditionally has been regarded asa self-limiting condition with spontaneous recovery within2 years.16 However, long-term follow-up studies have

shown that 40% of patients have persistent mild pain anshoulder motion limitation and that 11% of patients havpermanent functional disability of the shoulder joint.8,

Various treatment modalities have been introducedreduce pain and time to healing and to enable an ear 2012 Journal of Shoulder and Elbow Surgery Board of Trustees.Keywords: Corticosteroid injection; adhesive capsulitis; subacromial space; intra-articularepartment of Orthopaedic Surgery, School of Medicine, Ewha Womans University, Seoul, South

Background: A corticosteroid injection in the glenohumeral joint conducted blindly is technicallydemanding with a low rate of accuracy despite satisfactory clinical outcomes in the treatment for adhesivecapsulitis. This study prospectively compared the clinical outcomes of patients with idiopathic adhesivecapsulitis treated by a single corticosteroid injection in different locations of the shoulder.Materials and methods: We randomly assigned 191 patients with adhesive capsulitis to 1 of 4 groupsbased on corticosteroid injection location: group I, subacromial; group II, intra-articular; group III,intra-articular combined with subacromial space; and group IV, medication. Pain relief and patient satis-faction were assessed with a visual analog scale and functional outcomes were evaluated with the Amer-ican Shoulder and Elbow Surgeons score up to 24 weeks after treatment.Results: Patients treated with corticosteroids achieved faster pain relief and had greater satisfaction levelsthan patients in group IV during the 16 weeks after treatment. However, no significant difference in painscores was observed among the 4 groups at 24-week follow-up visits (P .670). Shoulder motion andfunction improved in all groups at final follow-up. However, shoulder motion in the injection groups recov-ered faster than that in group IV. At 24 weeks after treatment, no significant differences in shoulder motionor functional outcomes were found among the 4 groups (P .117).Conclusions: The efficacy of a single corticosteroid injection was not found to be related to the site ofinjection. However, a single corticosteroid injection provided faster pain relief, a higher level of patientsatisfaction, and an earlier improvement in shoulder motion and function than medication in patientswith adhesive capsulitis.Sang-Jin Shin, MD, PhD*, Seung-Yup Lee, MDof the shoulder for the treatee front matter 2012 Journal of Shoulder and Elbow Surgery/10.1016/j.jse.2012.06.015ction at different sitesent of adhesive capsulitis

www.elsevier.com/locate/ymseBoard of Trustees.

role in its pathogenesis. Furthermore, the majority of

The hypothesis of this study was that corticosteroid

to undergo one of the following treatment methods: corticosteroid

2 S.-J. Shin, S.-Y. Leeinjection in the subacromial bursa has the same therapeuticeffect and achieves the same functional outcomes as anintra-articular injection. The purposes of this randomized,controlled, prospective clinical study were to analyze theefficacy of a single corticosteroid injection administered atdifferent sites of the shoulder in patients with primaryadhesive capsulitis and to compare the clinical outcomesachieved with those of medication.

Materials and methods

From April 2007 to July 2009, 208 consecutive patients witha diagnosis of primary adhesive capsulitis were enrolled in thisstudy. Our institutional review board approved the study protocol,and informed consent was obtained from all participants. Theinclusion criteria applied were as follows: age of 18 years or older,shoulder pain with limitation of both active and passive shouldermovement in at least 2 directions (forward flexion

ORT

Efficacies of corticosteroid injection 3Figure 1 Flow diagram of patient recruitment based on CONSarticular; SA, subacromial.

Table I Clinical characteristics of 4 groups at baselineResults

The patients demographic and clinical characteristics atbaseline are summarized in Table I. Mean age, genderdistribution, and dominant shoulder involvement weresimilar in the 4 groups. No significant demographic differ-ences were observed among the 4 groups.

The visual analog scale score for pain was significantlyimproved after treatment in all groups at final follow-up(Fig. 2). However, pain relief was achieved significantlyfaster after a corticosteroid injection (groups I, II, and III)than after starting oral medication (group IV), and thisdifference was maintained for up to 16 weeks: 1.4 0.5 ingroup I, 1.4 0.4 in group II, 1.2 0.8 in group III, and3.1 0.5 in group IV (P < .05). Among the 3 corticosteroidinjection groups, group III showed the fastest pain relief,followed by group I and then group II; however, thedifferences were not significant. At 24 weeks follow-up,pain was gradually improved in group IV and no signifi-cant intergroup differences were found (P .670). Thecorticosteroid injection groups showed significantly betterpatient satisfaction for up to 16 weeks (P .022) (Fig. 3).High patient satisfaction in these 3 groups was achieved

I (SA) II

No. of patients 41 42Age (mean SD) (y) 53.9 4.1 55Sex (M/F) 14/27 16Duration of symptoms (mean SD) (mo) 7.7 3.3 7Side (dominant/nondominant) 27/14 30

F, female; IA, intra-articular; M, male; PO, oral medication; SA, subacromial.(Consolidated Standards of Reporting Trials) criteria. IA, intra-within 2 weeks of treatment. Although patients treated withcorticosteroids showed better early satisfaction with treat-ment, no significant differences were observed among the 3corticosteroid groups and group IV after 24 weeks follow-up (P .07).

At final follow-up, mean range of shoulder motionimproved in all 4 groups. Forward flexion of patients ingroups I, II, and II was significantly more rapidly restoredthan that of patients in group IV regardless of injection sitefor up to 16 weeks after treatment (P < .05) (Fig. 4).Forward flexion in patients who received a corticosteroidinjection increased by a mean of 12.4 3.1 beforephysiotherapy started. However, no significant differencewas observed in ranges of forward flexion among the 4groups at final follow-up evaluations (P .117). Externalrotation and internal rotation improvements followeda similar pattern in the 4 groups throughout the 24-weekfollow-up (Figs. 5 and 6). No significant intergroupdifferences were observed in baseline ASES scores (TableII). All shoulder functional outcomes recovered signifi-cantly in the 4 groups at final follow-up (P < .05). Althoughshoulder scores were higher in the corticosteroid injectiongroups than in group IV at each visit up to 16 weeks

(IA) III (SA IA) IV (PO) P value39 36

.1 4.6 56.3 5.8 57.3 6.4 .183/26 14/25 13/23 .986.4 3.4 7.0 2.6 6.8 2.7 .580/12 29/10 26/10 .857

4 S.-J. Shin, S.-Y. Lee(P .036), no intergroup difference was observed at 6months follow-up (P .651).

No infections related to corticosteroid injection occurredaround the shoulder joint. Three patients showed temporaryskin color changes around the injection site, and a steroidflare reaction developed in seven patients.

Discussion

In this study, the use of corticosteroid injection led to morerapid pain relief, better functional outcomes, and higherpatient satisfaction for up to 16 weeks after injection than

Figure 2 Visual analog scale (VAS)assessed pain improvedsignificantly faster in the corticosteroid injection groups (groups I,II, and III) than in group IVand remained lower for up to 16 weeksafter injection (asterisk, P < .05). No significant difference wasobserved among the 4 study groups at final follow-up. IA, intra-articular; PO, oral medication; SA, subacromial.

Figure 3 Patients were significantly more satisfied from 2weeks after corticosteroid injection than with NSAIDs, and thisdifference was maintained for up to 16 weeks (asterisk, P < .05).No significant differences were observed among the 4 groups atfinal follow-up. IA, intra-articular; PO, oral medication; SA, sub-acromial; VAS, visual analog scale.Figure 4 Forward flexion was restored significantly faster in thecorticosteroid injection groups (groups I, II, and III) than in groupIV, and this difference was maintained for up to 16 weeksoral medication. However, patients treated with cortico-steroid injection in the glenohumeral joint and the sub-acromial space achieved similar clinical outcomes at eachvisit.

Although adhesive capsulitis is a common disorder, itsoptimum treatment remains controversial. In the majorityof cases, a stiff shoulder responds well to conservativetreatments, which include oral NSAIDs, oral corticoste-roids, glenohumeral intra-articular corticosteroid injections,and physical therapy.2,3,7,12,14,15 Of these treatments, intra-articular corticosteroid injection achieves better clinicaloutcomes than the other treatments. Lorbach et al15

concluded that an intra-articular injection of corticoste-roid showed superior shoulder motion restoration comparedwith oral corticosteroid. Patients treated with intra-articularcorticosteroid injection with physical therapy achievedfaster symptom relief than those who underwent physical

(asterisk, P < .05). No significant differences were observedamong the 4 groups at final follow-up. IA, intra-articular; PO, oralmedication; SA, subacromial.

Figure 5 External rotation improved regardless of treatmentmethod at final follow-up evaluations. No significant differenceswere observed among the 4 groups during serial follow-up eval-uations. IA, intra-articular; PO, oral medication; SA, subacromial.

Efficacies of corticosteroid injection 5therapy only.23 In our study, patients treated with cortico-steroid injection showed faster pain relief and shoulderfunctional recovery than patients treated with oral medi-cation. However, this study showed that the benefits ofcorticosteroid were not maintained beyond 16 weeks afterinjection. Similar to the results of our study, the majority ofstudies have concluded that injected corticosteroid isprobably of limited short-term benefit in adhesive capsulitiscases. Bulgen et al4 showed that the initial response totreatment was most marked in patients treated with corti-costeroids but found no significant long-term outcomedifference versus patients treated with physical therapy orbenign neglect. Another study found that a patient treatedwith an intra-articular corticosteroid had a satisfactoryfunctional outcome at 6 weeks after injection comparedwith patients treated with physiotherapy only; however, thisdifference disappeared at 16 weeks after treatment.21 Earlytreatment with corticosteroids may chemically ablatesynovitis and thus limit the subsequent development of

Figure 6 Internal rotation improved regardless of treatmentmethod at final follow-up evaluations. No significant differenceswere observed among the 4 groups during serial follow-up eval-uations. IA, intra-articular; PO, oral medication; SA, subacromial.fibrosis and shorten the natural history of the disease.9

Despite the short-term benefits of corticosteroid injec-tion, we considered it worthwhile to use corticosteroid forthe treatment of adhesive capsulitis. One of the beneficialeffects of corticosteroid injection is pain relief, and reducedpain facilitates further treatment. Patients are satisfied withthe fast effects of the injection treatment, because mosthave had shoulder pain for a long time. In our study, patientsatisfaction after a corticosteroid injection was higher eventhough pain and shoulder function were no different fromthose achieved while patients were receiving oral medica-tion. Range of shoulder motion can be increased withoutphysical therapy when pain is reduced after injection;therefore, patients have more confidence in shoulder range-of-motion exercises because they can exercise moreaggressively with little pain. In this study, shoulder motion,especially forward flexion, spontaneously increased about12 before physiotherapy started because of reduced pain.However, the effect of corticosteroids on pain and satis-faction was more marked than those on shoulder range ofmotion, especially rotation. External rotation and internalrotation improved at a lower rate than forward flexionregardless of the treatment method used and requiredcontinuous stretching exercise.

In this study, patients injected in the subacromial spaceshowed similar functional recoveries to patients injected inthe glenohumeral joint. Previous studies compared only 2different injection sites and found that there were nosignificant differences in clinical outcomes between anintrabursal and intra-articular injection.17,20 We addedanother group of patients who were treated with both intra-articular and subacromial corticosteroid injections tocompare clinical outcomes of patients who were treatedwith separate injections. However, we could not find anybetter beneficial effects after simultaneous intra-articularand subacromial injection. It is interesting that shoulderfunction restoration is similar after a subacromial or intra-articular injection because adhesive capsulitis mainlyprovokes the glenohumeral capsular inflammatory changesthat trigger fibrosis and proliferative myelofibrosis.5,8

Although adhesive capsulitis primarily affects gleno-humeral capsular tissue, histologic findings proved thatcontractures of the coracohumeral ligament and rotatorinterval are also the main lesions in chronic adhesive cap-sulitis.18 In addition, release of the rotator interval appearsto be an essential part of the operative treatment of adhesivecapsulitis in terms of obtaining successful restoration ofshoulder motion.6,24 The coracohumeral ligament, whichreinforces the rotator interval, lies superficial to the superiorglenohumeral ligament and may be encountered in thesubacromial space. Therefore, the use of a subacromialinjection is considered to have a positive effect on adhesivecapsulitis. Andrieu et al1 found that the subacromial spaceis almost invariably involved in adhesive capsulitis andsuggested an adjuvant subacromial corticosteroid injectionin patients who do not respond to an intra-articular injec-tion. However, in our study, no additional benefits werefound after combined intra-articular and subacromialinjection compared with an isolated injection in eitherspace. A subacromial injection is technically easier than anintra-articular injection when conducted blindly. However,a subacromial injection of corticosteroid has potential sideeffects, especially when injected into muscle or tendon,because collagen fibers are weakened and late rotator cuffruptures may occur when corticosteroids are inadvertentlyinjected directly into the rotator cuff tendon.

NSAIDs have potent anti-inflammatory properties andare used to treat tendinitis of the rotator cuff and adhesivecapsulitis.13,14 Although literature on the effect of oralNSAIDs for adhesive capsulitis treatment is sparse, the useof NSAIDs has never been shown to improve pain orfunction as compared with a placebo.10 However, in thisstudy, we found that an oral aceclofenac dose of 100 mgdaily combined with physical therapy restored shoulder

fs

lc tasogdifficult to assess because of the high dropout rate. The

24 weeks after treatment according to corticosteroid injection site

wk

6.35.15.65.9

) Significant difference between corticosteroid groups (groups I, II, and IIIy Significant difference between pretreatment and post-treatment scores in e

6 S.-J. Shin, S.-Y. Leeoverall participation rate was 77%. The most commonreason for dropping out was an unwillingness to continuebecause of the failure of medication treatment. Further-more, some adhesive capsulitis cases may have comprisedrotator cuff tendinopathy, which showed similar clinicalcharacteristics to adhesive capsulitis. It was very difficult tomake a differential diagnosis between these 2 diseasesusing limited diagnostic tests, such as physical examinationand ultrasonography used in this study. Finally, patientswith different phases of adhesive capsulitis were present ineach group, and this was not adjusted for, which may haveinfluenced clinical outcomes and effects of corticosteroids.

Conclusion

Different corticosteroid injection sites of the shoulderwere found to have similar clinical outcomes in adhesivecapsulitis cases. However, a single corticosteroid injec-tion provided faster pain relief, a higher level of patientsatisfaction, and earlier improvements in range ofmotion and shoulder function than oral NSAIDs at up toroups were relatively small, and long-term outcomes wereunction at 24 weeks despite a slower rate than cortico-teroid injection.This study has several limitations. First, a subacromia

orticosteroid injection is not commonly used to treadhesive capsulitis, and it is not fully known how it affectshoulder function recovery, despite the good clinical resultsbtained. Second, the numbers of patients in the studyIA, intra-articular; PO, oral medication; SA, subacromial.

Data are given as mean SEM.Table II Differences in ASES shoulder scores from baseline to

Initial 2 wk 4

Group I (SA) 38.8 3.6 69.4 2.7 7Group II (IA) 42.6 3.1 73.9 2.6 8Group III (IA SA ) 39.5 2.6 72.9 4.6 8Group IV (PO) 37.7 2.9 49.4 3.6) 516 weeks after treatment.

Disclaimer

The authors, their immediate families, and any researchfoundations with which they are affiliated have notreceived anyfinancial payments or other benefits from anycommercial entity related to the subject of this article.References

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Efficacies of corticosteroid injection 7

Efficacies of corticosteroid injection at different sites of the shoulder for the treatment of adhesive capsulitisMaterials and methodsResultsDiscussionConclusionDisclaimerReferences