Hydrodilatation With Corticosteroid for the Treatment of Adhesive Capsulitis: A Systematic Review

Hydrodilatation With Corticosteroid for the Treatment of Adhesive Capsulitis: A Systematic Review

1 2 3 4 5 PM R XXX (2017) 1-13 www.pmrjournal.org 6 7 8 9 10 11 12 13 14 15 16 17 Q16 18 19 20 21 22 23 24 25 26 Abstract 27 28 29 Background: Current...
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1 2 3 4 5 PM R XXX (2017) 1-13 www.pmrjournal.org 6 7 8 9 10 11 12 13 14 15 16 17 Q16 18 19 20 21 22 23 24 25 26 Abstract 27 28 29 Background: Current evidence suggests that corticosteroid injection alone expedites the recovery of pain-free range of motion 30 (ROM) in patients with adhesive capsulitis compared to physiotherapy or placebo. However, it remains unclear whether the 31 addition of hydrodilatation with corticosteroid provides improvement in pain-free ROM as well as pain relief. 32 Objective: A review of the literature was conducted to determine whether the combined intervention of hydrodilatation and 33 34 corticosteroid injection expedites restoration of pain-free ROM compared to a control treatment of corticosteroid injection in 35 patients with adhesive capsulitis. 36 Methods: EMBASE, MEDLINE, and CINAHL were searched from database inception to January 2017. Relevant studies were 37 38 determined as randomized controlled trials written in English, comparing the outcomes of hydrodilatation and corticosteroid 39 injection to a control group treated with corticosteroid injection alone in patients with adhesive capsulitis. Two independent 40 reviewers assessed manuscripts for study inclusion and extracted data. 41 Results: A total of 2276 studies were identified through the search, of which 6 randomized controlled studies (involving 410 42 43 shoulders) met criteria for inclusion in this review. Mean age ranged from 51-61 years, with mean symptom duration of 4-9 44 months. Studies varied significantly regarding the volume of injectate, anatomical injection approach, symptom duration, and the 45 method of glenohumeral capsule distension (capsular rupture versus preservation). Two studies demonstrated clinically and 46 47 statistically significant improvement in the combination group at 3-month follow-up, and one study demonstrated clinically 48 significant improvement only in ROM and/or pain/functional scales, compared to 3 studies demonstrating no benefit when 49 compared to corticosteroid injection alone. 50 51 Conclusion: Combining hydrodilatation with corticosteroid injection potentially expedites recovery of pain-free ROM. The 52 greatest benefit is experienced within the first 3 months of intervention. Differences in hydrodilatation techniques, inclusion of 53 capsular preservation, anatomical approach, and length of symptoms may explain the variability in efficacy demonstrated. 54 Further trials using larger sample sizes, better anatomical approaches, image guidance, and hydrodilatation techniques are 55 56 required to determine the true nature of benefits of hydrodilatation with corticosteroid injection. 57 Level of Evidence: To be determined. 58 59 60 61 62 63 are otherwise active and healthy [4]. Persistent funcIntroduction 64 65 tional limitations and pain at longer follow-up periods 66 [5] have been reported, suggesting that a significant Adhesive capsulitis affects 2%-5% of the population 67 portion of patients may be left with residual deficits [6]. [1] and is a difficult condition to treat, resulting in sig68 69 Despite the prevalence of adhesive capsulitis, the nificant patient morbidity [2,3]. Adhesive capsulitis is 70 pathologic response and biochemical progression of characterized by severe pain that is associated with 71 72 disease within the glenohumeral joint remains uncerboth active and passive reduction in passive range of 73 tain. Current research has demonstrated that pain and motion (ROM) of the glenohumeral joint [2]. Patients are 74 75 limited ROM are due to a reduction in capsular volume typically symptomatic ranging from 6 months to 2 years 76 of the glenohumeral joint from a healthy volume of during their fifth or sixth decade of life, whereas they 77 78 79 1934-1482/$ - see front matter ª 2017 by the American Academy of Physical Medicine and Rehabilitation 80 https://doi.org/10.1016/j.pmrj.2017.10.013

Analytical Review

Hydrodilatation With Corticosteroid for the Treatment of Adhesive Capsulitis: A Systematic Review Michael Catapano, BHSc, MD, Nimish Mittal, MBBS, MD, John Adamich, BHSc, MD(C), Dinesh Kumbhare, MD, MSc, FRCPC, DABPMR, Harpreet Sangha, MD, FRCPC, Dip CSCN (EMG)

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Hydrodilatation for Adhesive Capsulitis

28-35 mL to about 5-10 mL in the diseased state [7]. The initial painful stage is characterized by hypertrophic, vascularized synovitis without adhesions or capsular contracture [8]. Synovial biopsy findings have added significantly to our understanding by demonstrating an inflammatory profile, including chronic inflammatory infiltrate, absence of a synovial lining, moderate to extensive subsynovial fibrosis, and perivascular lymphocytic reaction [9]. Capsular contracture appears to be the hallmark of the frozen stage, the second stage of adhesive capsulitis, characterized histologically by deposition of disorganized collagen fibrils with hypercellular collagenous tissue, patchy synovial thickening, and loss of axillary recess with absence of inflammatory infiltrates [8]. Adhesive capsulitis is often managed conservatively, with an approach that may include pain management and physiotherapy [10]. However a multitude of interventions have been trialed to expedite recovery, including intraarticular corticosteroid injection, manipulation under anaesthesia, arthroscopic release, suprascapular nerve blocks, and hydrodilatation [8]. Intra-articular corticosteroid injections into the glenohumeral joint have been definitely demonstrated, in multiple randomized controlled trials, to result in early return of pain-free ROM compared to both placebo and conservative treatment [11-16]. The addition of hydrodilatation to the standard of care (ie, corticosteroid injection) may work synergistically to improve adhesive capsulitis outcomes by providing an immediate expansion of the capsule that can be maintained through either sustained hydraulic pressure or physiotherapy [17]. Currently it is very difficult to quantify the proportion of patients left with residual deficits; however, the combination of hydrodilatation and corticosteroid injection may also reduce the prevalence of long-term deficits [17]. The aim of this systematic review was to analyze current available randomized controlled trials to determine whether there is a synergistic effect of corticosteroid injection and hydrodilatation in the treatment of adhesive capsulitis compared to standardof-care corticosteroid injection. This systematic review builds on the previous Cochrane Review by Buchbinder et al [17] by further elucidating whether hydrodilatation with corticosteroid injection is better than the alternative intervention of corticosteroid injection alone, by the inclusion of recently published randomized controlled trials and refined trial inclusion criteria with appropriate control groups. Methods Search Strategy and Assessment of Study Eligibility This review was formatted and based upon Preferred Reporting Items for Systematic Review and

Meta-analysis (PRISMA) guidelines. MEDLINE, EMBASE, and CINAHL were searched from database inception to January 1, 2017, for articles addressing hydrodilatation for adhesive capsulitis of the shoulder. The search criteria were adapted from previously published systematic reviews to be more inclusive [17]. The search clause for EMBASE is presented in Figure 1. Systematic article screening was performed independently and in duplicate, from titles through to full text by 2 of the authors (M.C. and J.A.) and recorded in Covidence (2016). Only articles published in English were included. Criteria for inclusion were as follows: Level I evidence; hydrodilatation with corticosteroid injection group; and intra-articular corticosteroid injection control group. Exclusion criteria were systematic reviews; Level II evidence or lower; and animal models or cadaveric studies. Throughout the title and abstract screening stages, any article with discordance between reviewers was included to ensure that no relevant articles were prematurely excluded. The reviewers discussed any disagreements at the full-text stage and if consensus was not reached, a third reviewer provided input regarding each article’s eligibility. The reference lists of all included studies were additionally screened to obtain more relevant articles. Data extraction was done in duplicate. The PEDro Scale [18] was used to assess the quality of the included studies. This scale has been validated in the evaluation of multiple physical medicine interventions using an 11-point criterion. Clinical trials are scored based on clarity of eligibility criteria, allocation, equivalency of baseline demographics between groups, blinding, and completeness of follow-up and outcome measures. High-quality evidence has been defined as scores between 6 and 10, fair quality defined as scores between 4 and 5, and poor quality defined as scores below 3. (For further details about PEDro, the reader is referred to reference 18.) Results After duplicates were removed, 2276 were included in the title and abstract screening phase. Following the title and abstract screen, 151 studies progressed to full text review. A total of 146 studies were removed by the full text review, leaving 5 articles to be included for analysis, with the addition of one article found via reference searches (Figure 2). PEDro scale scores were above 7 for all included studies. As a physician administering the procedure cannot be blinded, no study was able to obtain a score of 11. The majority of studies did not clearly blind subjects to group allocation. Table 1 and 2 provide descriptive characteristics of the studies included, and Table 3 lists the respective outcome measures and main results. Jacobs et al [19] conducted a randomized control trial of 50 shoulders randomized to receive hydrodilatation, corticosteroid injection, or hydrodilatation

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Database: Embase Classic+Embase <1947 to 2016 March 03> Search Strategy: -------------------------------------------------------------------------------1 shoulder pain/ (11441) 2 rotator cuff/ (4656) 3 bursi s/ (4665) 4 frozen shoulder/ (1564) 5 humeroscapular periarthri s/ (1773) 6 supraspinatus muscle/ (507) 7 shoulder impingement syndrome/ (1984) 8 rotator cuff injury/ (1302) 9 ((shoulder* or rotator cuff) adj5 (bursi s or frozen or impinge* or tendini s or tendoni s or pain*)).mp. (21096) 10 rotator cuff.mp. (11436) 11 capsuli *.mp. (1116) 12 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 (33495) 13 dilata on/ (12206) 14 arthrography/ (6092) 15 (dilatat* or distension).mp. (153707) 16 hydrodilat*.mp. (43) 17 intraar cular drug administra on/ (6783) 18 13 or 14 or 15 or 16 or 17 (166313) 19 12 and 18 (1748) 20 (exp animals/ or exp animal experimenta on/ or nonhuman/) not ((exp animals/ or exp animal experimenta on/ or nonhuman/) and exp human/) (6206037) 21 19 not 20 (1736) 22 exp embryo/ or exp fetus/ or exp juvenile/ (3516029) 23 exp adult/ (6116305) 24 22 not (22 and 23) (2403377) 25 21 not 24 (1711) 26 limit 25 to embase (1472) Figure 1. Search strategy (Embase).

with corticosteroid injection performed via a landmarkbased posterior approach [19]. Participants were offered a total of 3 injections at 6-week intervals unless they either refused or had a dramatically improved range of movement and no pain. Injections consisted of hydrodilatation (bupivacaine with air; total volume 9 mL); corticosteroid injectiononly group (triamcinolone acetonide; total volume 1 mL); and corticosteroid injection and hydrodilatation group (triamcinolone acetonide, bupivacaine and air; total volume 10 mL). Patients were followed up at baseline and at 6, 12, and 16 weeks postintervention. Three patients dropped out of the study between the fourth and eighth weeks for reasons unrelated to the study, and one patient was unable to continue due to a cerebrovascular accident. At the end of 16-week period, patients receiving hydrodilatation with corticosteroid injection achieved the greatest overall improvement in ROM, with improvement of 4.3 , 3.6 , and 2.1 per week, compared to the corticosteroid injection group of 3.4 , 3.3 , and 1.7 per week in abduction, flexion, and external rotation, respectively. However, although this improvement was clinically significant, it was not statistically significant. Gam et al [20] conducted a randomized controlled trial comparing the combination of hydrodilatation

with lidocaine and triamcinolonhexetonide to triamcinolonhexetonide alone via a landmark-based posterior approach [20]. Hydrodilatation was confirmed via ultrasound demonstrating enlarged joint space compared to preinjection images. Capsular preservation was not directly commented on during ultrasonography. Patients were offered injections once per week for a maximum of 6 weeks or until no symptoms remained, and were asked to record daily analgesic use and pain at rest and with function on a visual analog scale (VAS). An impartial physician who was not involved in treatment administration and was unaware of the treatment that each patient received examined patients at inclusion and at 3, 6, and 12 weeks. Of the 20 patients included in the analysis, patients treated with hydrodilatation and corticosteroid injection achieved nonstatistically significant pain relief with a VAS scores at 12 weeks of 2 and 0 compared to 1 and 3 in the controls at rest and with function, respectively. Analgesic consumption (P ¼ .008), flexion (not reported), extension ROM (P ¼ .03), external rotation ROM (P ¼ .01), and physician impression of symptom severity (P ¼ .002) all demonstrated significant benefit in the population receiving hydrodilatation and corticosteroid injection as compared to the corticosteroid injectiononly group.

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Hydrodilatation for Adhesive Capsulitis

Medline: 966 Ar cles Embase: 1,472 Ar cles CINAHL: 1,910 Ar cles Total: 4,348 Ar cles

Duplicates Removed: 2,072 Ar cles

Title Screen: 2276 Ar cles

Removed at Title Screen: 2125 Ar cles

Full Text Screen: 151 Ar cles

Removed at Full Text Screen: 146 Ar cles - Inappropriate controls - Wrong pa ent popula on - Not in English Manual Search from Reference Lists: 1 Ar cle

6 Ar cles Included Figure 2. Screening process.

Tveita et al studied 76 shoulders that were randomized to receive hydrodilatation with corticosteroid injection consisting of contrast medium, triamcinolone acetonide, bupivacaine, and saline solution or intraarticular injection alone with contrast medium, triamcinolone acetonide, and bupivacaine [21]. Patients received 3 injections at 2-week intervals administered via an anterior approach under fluoroscopy using a KaySchneider technique. Capsular rupture was ensured in dilatation patients with continual injection until there was a recorded loss of resistance, and contrast leakage was identified by fluoroscopy. Patients were followed up at 6 weeks after their last appointment with Shoulder Pain and Disability Index (SPADI) scores and active and passive ROM. Both groups had significant improvement; however there was a small observed difference in DSPADI scores of 3 favoring the dilatation group, although this was not significant (confidence interval ¼ 5 to 11). There was no

difference between groups in passive or active ROM in abduction, forward flexion, or external or internal rotation. Reza et al conducted a randomized controlled trial of 100 shoulders equally randomized to receive either hydrodilatation with saline solution, contrast material, lidocaine, and triamicinolone acetonide or triamicinolone acetonide alone [22]. Injections were performed under fluoroscopic guidance via an anteriorelateral approach, and all patients were given a program of active home exercises focusing on active shoulder ROM for 1 week. Patients were assessed at inclusion and at 2 days and 12 weeks after intervention with VAS and active ROM. The patients receiving hydrodilatation demonstrated significant improvement in VAS scores (P ¼ .002) and ROM in flexion (P ¼ .009), abduction (P ¼ .005), and internal rotation (P ¼ .027) at 12 weeks, with the majority of change occurring within the first 2 days.

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62/68 67/51 50/69 67/62.5 58/62 50/50

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Yoon et al conducted a controlled trial of 90 shoulders randomized to either hydrodilatation with corticosteroid injection of triamcinolone, lidocaine, and normal saline solution under fluoroscopic guidance or corticosteroid injections of triamcinolone alone into the subacromial space or glenohumeral joint [23]. Patients received one injection and were evaluated at inclusion and at 1, 3, and 6 months after treatment using a VAS score, Simple Shoulder Test (SST), Constant score, and passive shoulder ROM (forward flexion and external and internal rotation). At 1 month, patients receiving hydrodilatation and corticosteroid injection had significantly greater improvement in VAS score (P ¼ .035), SST (P ¼ .02), forward flexion (P ¼ .009), and external rotation (P ¼ .05) than patients treated with both methods of corticosteroid injections. However, except for SST and Constant score (between the HD and IAI group) that were maintained at 3 months (P ¼ .05), there was no significant improvement in any other measured outcome at 3 and 6 months. Sharma et al demonstrated in 106 shoulders that hydrodilatation with triamcinolone, lidocaine, and sodium chloride for a total injectate volume of 8-20 mL was not superior at the 4-week, 8-week, or 12-month follow-up compared to intra-articular injection of triamcinolone and lidocaine [24]. Patients in both intervention groups received injections via a landmarkbased posterior approach on the day of randomization and after 7, 17, and 31 days from the start, with outcome measured being evaluated by a blinded assessor at 4 weeks and 8 weeks. In addition, the SPADI was re-administered via mail at 12 months postintervention. The investigators did not demonstrate any difference between intervention groups with a calculated effect size for SPADI from baseline to be 0.0 and 0.1 between the interarticular injection and hydrodilatation group at 8 weeks and 12 months, respectively. Moreover, there was no statistically difference between group differences in change in the SPADI, numeric pain rating scale (NPRS), or ROM in abduction, external rotation, internal rotation, or hand behind back at 4 and 8 weeks in an analysis of covariance.

28/29 38/37 18/16 12/8 32/34 50/50 8 7 8 8 10 8

53/54 52/51 55/52 53.5/47 52/53 61/58

Symptom Duration, mo, Cases/Controls % Women, Cases/Controls Age, y, Cases/Controls Cases/Controls (n) PEDro Scale Score (/11)

5

RCT ¼ randomized controlled trial.

Korea Norway UK Denmark Norway Iran Yoon et al [23] Tveita et al [21] Jacobs et al [19] Gam et al [20] Sharma et al [24] Reza et al [22]

2016 2008 1991 1998 2016 2013

Country Study

Year

Discussion

Table 1 Demographics of included studies

641 642 643 644 645 646 647 648 649 650 651 652 653 654 655 656 657 658 659 660 661 662 663 664 665 666 667 668 669 670 671 672 673 674 675 676 677 678 679 680 681 682 683 684 685 686 687 688 689 690 691 692 693 694 695 696 697 698 699 700 701 702 703 704 705 706 707 708 709 710 711 712 713 714 715 716 717 718 719 720

Follow-up (wk)

M. Catapano et al. / PM R XXX (2017) 1-13

Hydrodilatation with corticosteroid injection has gained popularity due to its theoretical benefit of simultaneous treatment of the inflammatory reaction and constricted glenohumeral joint. Current randomized controlled trials have produced conflicting results as to whether this theoretical benefit translates to clinically evident improvements compared to corticosteroid injection alone. Two studies, by Reza et al [22] and Gam et al [20], demonstrated significant improvement in pain and function in patients receiving the combined intervention of hydrodilatation compared to corticosteroid injection alone at 1-month and 3-month

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Diagnostic Criteria

Yoon et al [23] (2016)

Patients included consisted of those with limited active and passive ROM in at least 2 directions (abduction and forward flexion <100 , external rotation <20 , or internal rotation/ Apley’s Test score 30 for at least 2 ranges of forward flexion, abduction, or external rotation compared to the unaffected side, pain predominantly in one shoulder lasting >3 months and <2 years. Those with a clinical history of diabetes mellitus, trauma to the shoulder in the past 6 months requiring hospital care, serious mental illness, cancer, glenohumeral arthritis, glenohumeral dislocations, or full-thickness rotator cuff tears with displacement of the humeral head were excluded from the study. Included patients consisted of those with abduction and forward flexion <90 , external rotation <20 , intact rotator cuff via clinical testing, and normal shoulder radiographs. Patients were included regardless of severity of pain when using the limb, at rest or at night, history of trauma, or duration of symptoms. Patients with diabetes mellitus or a myocardial infarction were excluded from the study.

Tveita et al [21] (2008)

Jacobset al [19] (1991)

Prior Conservative Treatment(s) Patients included within the study were not allowed to have previous treatments of manipulation under anaesthesia, suprascapular nerve injection, or have received a steroid injection within the 6 months prior to enrollment. Prior use of other conservative therapy was not reported. Prior to inclusion, some patients were taking oral medication for shoulder pain including acetaminophen or various NSAIDs, and a few were receiving physiotherapy. Patients were excluded if they were taking oral corticosteroids. Patients were not instructed to attend physiotherapy but were allowed to proceed with their current treatment program if they wished. Prior use of conservative therapy was not reported. All patients were given an information sheet with a home exercise program; however, compliance was not assessed.

Injectate direction

Amount of Injectate (Capsular Effect)

Comparison Group(s)

Intervention

Intra-articular injection: 1 mL triamcinolone 40 mg, 4 mL 2% lidocaine, and 5 mL of normal saline solution in the glenohumeral joint using an anterior approach with patients in the supine position Subacromial injection: 1 mL triamcinolone 40 mg, 4 mL 2% lidocaine, and 5 mL of normal saline solution into the subacromial bursa using a posterior approach under ultrasound guidance Intra-articular injection: 3-4 mL contrast medium, 2 mL (20 mg) triamcinolone, and 3-4 mL of 5 mg/mL bupivacaine was injected using fluoroscopy and an anterior approach with needle placement at about the junction of the middle and lower third of the glenohumeral joint space.

Single injection under fluoroscopy, using an anterior approach whereby needle placement was medial to the head of the humerus and approximately 1 cm lateral to the coracoid process.

Injectate was directed posteriorly, slightly superiorly, and laterally.

- 1 mL (40 mg) triamcinolone - 4 mL 2% lidocaine - 40 mL normal saline solution (Capsule ruptured)

Arthrograms were performed according to the Kaye-Schneider technique and injected using fluoroscopy and an anterior approach with needle placement at about the junction of the middle and lower third of the glenohumeral joint space.

Needle was directed posteriorly and slightly superiorly and medially as described by the KaySchneider technique

- 4 mL of contrast medium - 2 mL (20 mg) triamcinolone - 4 mL 5 mg/mL bupivacaine - 10 mL saline solution (Capsule ruptured)

Injections were preformed via a posterior approach using a landmark-based technique with the infiltration of the capsule through the posterior corner of the acromion and the needle held horizontally toward the coracoid.

Needle was positioned anterior and superiorly, directed toward the coracoid process.

- 1 mL (40 mg) triamcinolone - 6 mL 0.25% bupivacaine - 3 mL air (Inferred capsule preservation)

Hydrodilatation without corticosteroid: injection of 6 mL 0.25% bupivacaine and 3 mL air via a landmarkbased posterior approach that was identical to the hydrodilatation with corticosteroid technique. Intra-articular injection: 1 mL triamcinolone (40 mg) via a landmark-based posterior approach that was identical to the hydrodilatation with corticosteroid technique.

Hydrodilatation for Adhesive Capsulitis

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Study

6

Table 2 Descriptions of included studies

881 882 883 884 885 886 887 888 889 890 891 892 893 894 895 896 897 898 899 900 901 902 903 904 905 906 907 908 909 910 911 912 913 914 915 916 917 918 919 920 921 922 923 924 925 926 927 928 929 930 931 932 933 934 935 936 937 938 939 940 941 942 943 944 945 946 947 948 949 950 951 952 953 954 955 956 957 958 959 960

961 962 963 964 965 966 967 968 969 970 971 972 973 974 975 976 977 978 979 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 995 996 997 998 999 1000 1001 1002 1003 1004 1005 1006 1007 1008 1009 1010 1011 1012 1013 1014 1015 1016 1017 1018 1019 1020 1021 1022 1023 1024 1025 1026 1027 1028 1029 1030 1031 1032 1033 1034 1035 1036 1037 1038 1039 1040

Gam et al [20] (1998)

Reza et al [22] (2013)

Those included in the study had no other treatment for adhesive capsulitis other than analgesics in the study period. Prior treatment for adhesive capsulitis in this patient population was not reported.

Intra-articular injection: 1 mL (20 mg) of triamcinolone alone via a posterior approach identical to that use for the hydrodilatation technique. The treatment was repeated once/wk for a maximum of 6 wk or until no symptoms were present

Injection was carried out via a posterior approach verified by ultrasound. The treatment was repeated once/wk for a maximum of 6 wk or until no symptoms were present.

Needle placement was directed anteriorly with a 1.5inch needle perpendicular to the scapulae spine.

- 19 mL 1%-2% lidocaine - 1 mL (20 mg) triamcinolone (Inferred capsular preservation)

Not reported

Injections were carried out via a landmarkbased posterior approach. Injections were given after inclusion on day 1 and after 7, 17, and 31 days from the start.

Needle placement was directed anteriorly using a landmarkbased injection technique.

- 1 mL (20 mg) triamcinolone - 3 mL lidocaine - Sodium chloride 9 mg/mL to total 8 to >20 mL (Unknown capsular effect)

Patients included were those with a painful stiff shoulder for >3 months without evidence of gross infection, inflammatory disease, spaceoccupying lesions, shoulder bony lesions, or calcium deposits around the joint on a complete blood count with ESR or shoulder and neck radiography. Those with clinical evidence of abnormal muscular mass around the arm or shoulder suggestive of rotator cuff tendon tearing, fever, pain on touching of the shoulder, or history of pregnancy, diabetes mellitus, or polyarthritis were excluded.

Not reported

Intra-articular Injection: 1 ml (20 mg) triamcinolone and 3 mL 10 mg/mL lidocaine for a total of 4 mL injected into the glenohumeral joint via a landmark-based posterior approach. Treatment-as-usual: informed about the possibilities of optional conservative treatment, such as physiotherapy or pain medication other than corticosteroid injections or per oral corticosteroid medication until 61 days after inclusion Intra-articular injection: injection of 1 mL (40 mg) triamcinolone was injected into the shoulder joint via an anterior-lateral method. A program of active home exercises focusing on active shoulder ROM for 1 wk followed the injections.

Arthrographic shoulder capsule distension was performed through an anterior-lateral approach under fluoroscopic guidance. Patients sat with their affected arms in maximal external rotated position.

Not reported

- 1 mL [40 mg] triamcinolone acetonide - 2 mL 2% lidocaine - 20 mL contrast material - 27 mL normal saline solution (Capsule ruptured)

7

ESR ¼ erythrocyte sedimentation rate; NSAIDs ¼ nonsteroidal anti-inflammatory drugs; ROM ¼ range of motion; VAS ¼ visual analog scale.

M. Catapano et al. / PM R XXX (2017) 1-13

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Sharma et al [24] (2016)

Included patients consisted of those referred with a diagnosis of adhesive capsulitis of 6 wk or more duration and nocturnal accentuation of pain, 50% or less passive range of motion in external rotation compared to the contralateral shoulder, no glenohumeral effusion, normal shoulder x-rays, normal ESR, hemoglobin, leukocytes, alkali phosphatase, and negative IgM rheumatoid factor, no history of significant shoulder trauma in the last 6 months that resulted in pain or restricted movement of the shoulder (minor trivial injuries accepted), and no diabetes. Patients included in the study were those with reduced passive range of motion more than 30% of 2 of 3 shoulder movements and no normal movement of shoulder abduction, external rotation, and internal rotation compared to the contralateral side. Patients with diabetes or asthma, pregnant women, and breastfeeding women were excluded.

1041 1042 1043 1044 1045 1046 1047 1048 1049 1050 1051 1052 1053 1054 1055 1056 1057 1058 1059 1060 1061 1062 1063 1064 1065 1066 1067 1068 1069 1070 1071 1072 1073 1074 1075 1076 1077 1078 1079 1080 1081 1082 1083 1084 1085 1086 1087 1088 1089 1090 1091 1092 1093 1094 1095 1096 1097 1098 1099 1100 1101 1102 1103 1104 1105 1106 1107 1108 1109 1110 1111 1112 1113 1114 1115 1116 1117 1118 1119 1120

1121 1122 1123 1124 1125 1126 1127 1128 1129 1130 1131 1132 1133 1134 1135 1136 1137 1138 1139 1140 1141 1142 1143 1144 1145 1146 1147 1148 1149 1150 1151 1152 1153 1154 1155 1156 1157 1158 1159 1160 1161 1162 1163 1164 1165 1166 1167 1168 1169 1170 1171 1172 1173 1174 1175 1176 1177 1178 1179 1180 1181 1182 1183 1184 1185 1186 1187 1188 1189 1190 1191 1192 1193 1194 1195 1196 1197 1198 1199 1200

8

Table 3 Study results for included studies Main Results

Authors’ Conclusions

Yoon et al [23] (2016)

VAS score: IAI 5.6 (2.1), 4.6 (1.1), 4.4 (1.5), 1.9 (1.1) vs HD 5.8 (1.5), 3.6 (1.3), 3.4 (1.4), 2.1 (1.3) at baseline, 1 m, 3 mo, and 6 mo, respectively. Simple Shoulder Test Score: IAI 3.2 (1.8), 6.0 (2.5), 6.8 (1.6), 8.3 (1.2) vs HD 3.2 (2.2), 7.8 (2.0), 8.7 (3.4), 8.9 (1.2) at baseline, 1 mo, 3 mo, and 6 mo, respectively. Constant Score: IAI 58.6 (17.1), 67.4 (19.8), 73.6 (18.1), 80.1 (14.2) vs HD 57.4 (20.0), 78.1 (16.8), 77.3 (18.1), 85.1 (11.2) at baseline, 1 mo, 3 mo, and 6 mo, respectively. SPADI: IAI 59 (20), 20 (17) vs HD 63 (20), 26 (19) at baseline and 6 wk, respectively. Passive ROM (with scapula stabilized): aROM IAI 31 (11), 46 (13) vs HD 31 (11), 44 (12) at baseline and 6 wk, respectively ffROM IAI 46 (17), 65 (12) vs HD 48 (14), 61 (13) at baseline and 6 wk, respectively extROM IAI 16 (14), 29 (16) vs HD 19 (13), 27 (17) at baseline and 6 wk, respectively intROM IAI 31 (13), 48 (15) vs HD 34 (14), 45 (12) at baseline and 6 wk, respectively ROM: aROM IAI 3.4 (2.4-4.5) vs HD 4.3 (3.4-5.2) in degrees/wk (95% confidence interval) at baseline and 16 wk ffROM IAI 3.3 (2.3-4.3) vs HD 3.6 (3.2-4.0) in degrees/wk (95% confidence interval) at baseline and 16 wk extROM IAI 1.7 (1.2-2.3) vs HD 2.1 (1.6-2.6) in degrees/wk (95% confidence interval) at baseline and 16 wk VAS with resisted movement NR at baseline and 16 wk VAS: At Rest IAI 4 (2-6), 1 (0-6) vs HD 3 (2-7), 2 (0-5) at baseline and 12 wk With Function IAI 4 (3-7), 3 (2-8) vs HD 5 (4-5), 0 (0-1) at baseline and 12 wk Analgesic use: IAI 1 (0-3), 0.5 (0-2) vs HD 2 (1-3), 0 (0-0) at baseline and 12 wk Exact values for ROM were not reported. However there was significant improvement in all ROMs (extension, forward flexion, external rotation) except abduction. Extension and external rotation was significant from wk 7, respectively pw 0.03 and 0.01. Exact values for physician impression were not reported. However the physicians impression also showed a significant difference in wk 7 and 12 in favor of distension, respectively pw 0.01 and 0.002. SPADI: IAI 63.8 (16.0), 34.1 (21.4), 23.8 (22.0), 16.9 (18.9) vs HD 60.5 (16.8), 30.9 (21.0), 20.1 (18.4), 17.2 (19.8) at baseline, 4 wk, 8 wk, and 12 mo, respectively NPRS: IAI 6.9 (1.4), 3.8 (2.2), 3.0 (2.3) vs HD 7.2 (1.6), 3.5 (1.7), 2.9 (1.6) at baseline, 4 wk, and 8 wk, respectively PROM: aROM IAI 53.7 (13.4), 62.7 (15.6), 68.9 (15.3) vs HD 51.0 (17.8), 64.7 (17.2), 71.9 (17.0) in degrees at baseline, 4 wk, and 8 wk, respectively extROM IAI 19.6 (14.7), 30.1 (16.3), 38.2 (17.6) vs HD 25.2 (17.7), 35.6 (15.8), 42.7 (17.9) in degrees at baseline, 4 wk, and 8 wk, respectively IntROM IAI 38.8 (15.5), 49.5 (17.4), 57.2 (15.7) vs HD 41.1 (14.1), 42.7 (17.3), 59.6 (16.1) in degrees at baseline, 4 wk, and 8 wk, respectively

Hydrodilatation > intra-articular steroid injection and subacromial injection at 1 and 3 mo in terms of functional scores. However, for VAS and ROM, the HD group performed better statistically at 1 month with similar effects at 3 and 6 mo. No difference between injection techniques at 6 mo.

Tveita et al [21] (2008)

Jacobs et al [19] (1991)

Gam et al [20] (1998)

Sharma [24] et al (2016)

Q14

No difference at 6-wk follow-up.

Hydrodilatation for Adhesive Capsulitis

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Study

Greatest improvement in passive ROM in the distension and steroid group; however not statistically significantly better. Both steroid and distension and steroid group were better than distension only.

Corticosteroid and distension demonstrated a statistically significant difference in ROM in all directions except abduction and analgesic sparing. Clinically significant but statistically nonsignificant differences in VAS scores were reported.

Q15

No significant difference between hydrodilatation and corticosteroid compared to corticosteroid alone for any outcome measure at 4 wk, 8 wk, or 12 mo.

1201 1202 1203 1204 1205 1206 1207 1208 1209 1210 1211 1212 1213 1214 1215 1216 1217 1218 1219 1220 1221 1222 1223 1224 1225 1226 1227 1228 1229 1230 1231 1232 1233 1234 1235 1236 1237 1238 1239 1240 1241 1242 1243 1244 1245 1246 1247 1248 1249 1250 1251 1252 1253 1254 1255 1256 1257 1258 1259 1260 1261 1262 1263 1264 1265 1266 1267 1268 1269 1270 1271 1272 1273 1274 1275 1276 1277 1278 1279 1280

VAS ¼ visual analog scale; IAI ¼ intra-articular injection of corticosteroid; HD ¼ hydrodilatation with corticosteroid; SPADI ¼ Shoulder Pain and Disability Index; aROM ¼ abduction range of motion; ffROM ¼ forward flexion range of motion; extROM ¼ external range of motion; intROM ¼ internal range of motion; ROM ¼ range of motion; NPRS ¼ numeric pain rating scale; PROM ¼ passive range of motion.

Statistically significant difference in both active ROM and VAS score at both 2 days and 12 wk postintervention. VAS with function: IAI 7.46 (1.15), 6.76 (1.17), 3.57 (1.1) vs HD 7.96 (0.98), 4.33 (1.00), 3.29 (0.95) at baseline, 2 days, and 12 wk postintervention ROM: aROM IAI 65.4 (21.1), 72.6 (24.9), 82.7 (22.6) vs HD 63.8 (25.6), 102.7 (30.7), 114.4 (30.1) at baseline, 2 days, and 12 wk ffROM IAI 66.3 (24.2), 75 (21.7), 84.8 (21.3) vs HD 66.6 (29.5), 104.4 (32), 110.8 (33.3) at baseline, 2 days, and 12 wk extROM IAI 22.7 (11.06), 28.1 (10.9), 36.2 (12.2) vs HD 20.4 (12.5), 40.9 (17.5), 50.8 (17.2) at baseline, 2 days, and 12 wk intROM IAI 31.5 (11.8), 36.9 (11.5), 48.4 (10.8) vs HD 33.6 (21), 48.1 (19.6), 55.4 (18.2) at baseline, 2 days, and 12 wk Reza et al [22] (2013)

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9

follow-up. This benefit was also experienced in patients in the Jacobs et al [19] study. However, because of a small sample size without adequate power, this difference failed to reach statistical significance. The improvements in pain and ROM seen in the studies previously discussed was also documented by Yoon et al [23] at 1 month; however there was no appreciable improvement at long-term follow-ups of 3 and 6 months. In contrast, Tveita et al [21] and Sharma et al [24] demonstrated no difference at 1- and 2-month followup, or at 1-year follow-up demonstrated by Sharma et al between patients receiving the combined intervention versus corticosteroid injection alone. One of the reasons for this large variability in effectiveness among randomized controlled trials may stem from the technique used to dilate the glenohumeral capsule in each study. Each study used a unique protocol consisting of varying volumes and consistencies of injectate, varying anatomical injection approaches, and varying volumes used in the comparison groups. As such, studies were evaluated individually for trends; however, we were not able to combine data from each of the studies, as it would not appropriately synthesize the total results. Study protocols differed in their aim to obtain capsular rupture during hydrodilatation. This variability stems from initial theories that maximal expansion, where capsular rupture was achieved, would result in the greatest dilatation of the capsule and translate to maximal clinical improvement. This theory was based on studies of hydrodilatation without corticosteroid injection. In these studies, there was a small appreciable clinical improvement with protocols obtaining capsular rupture (CR) [25-28] compared to those where there was capsular preservation (CP) [14,19,29]. Recently, this theory was tested in a randomized, head-to-head clinical trial of capsular CP versus capsular CR [30] with the addition of corticosteroid. A total of 46 patients were randomized to receive hydrodilatation with corticosteroid with the purpose of either CP and CR. Intraarticular administration of 40 mg triamcinolone was administered in both groups. The desired capsular effect was confirmed postintervention using ultrasound imaging and continued intra-articular pressure monitoring. Between-group comparison demonstrated that there was a larger decrease in VAS score in patients in the CP group compared to those in the CR group. This improvement was significant at 3 days (P ¼ .032) and marginal at 1 month (P ¼ .075). There was increased improvement in abduction ROM (P ¼ .035 and .011), summed ROM (P ¼ .068 and .043), and Apley’s Test score (P ¼ .002 and .013) in patients with CP than in those with CR group at 3 days and 1 month, respectively. The additional benefit attained by those in the CP group has been proposed to be a result of maintained pressure in the glenohumeral joint causing continual capsular distension without rupture postintervention and the appropriate delivery of corticosteroid [30].

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Hydrodilatation for Adhesive Capsulitis

1441 Those studies included in this review in which there 1442 can be inferred CP based upon review of study meth1443 1444 odology reported clinically significant improvements 1445 in patient outcomes with the addition of hydro1446 dilatation. Capsular preservation was not measured by 1447 1448 any study; however, 2 studies [19,20] in this review 1449 likely maintained capsule integrity. Jacobs et al [19] 1450 1451 used a total injectate volume of 10 mL, which is 1452 significantly below the average volume needed to 1453 achieve CR (18.5-25.8 mL) [31]. From this we have 1454 1455 inferred that there is likely CP in the majority of pa1456 tients, with a small number experiencing CR, as 1457 1458 described to occur with volumes as low as 8 mL [30]. 1459 Gam et al [20] performed ultrasound evaluation 1460 1461 postintervention to ensure appropriate anterior dila1462 tation after the infusion of 20 mL. Although we cannot 1463 ensure the capsular effect during their procedure, it 1464 1465 can be inferred that there is likely CP in a significant 1466 portion of the population due to the moderate amount 1467 1468 of injectate and maintained capsular dilatation post1469 procedure on ultrasound. We cannot be sure how long 1470 the distension was maintained and whether there was 1471 1472 subsequent rupture after ultrasound evaluation, as a 1473 mean time to rupture has been reported as 400 sec1474 1475 onds [31]. This is in contrast to the 3 studies [21,22,32] 1476 reported in this review that ensured CR, of which only 1477 one study [22] demonstrated maintained benefits with 1478 1479 the addition of hydrodilatation. In one study, Sharma 1480 Q7 et al [24] were unable to comment on the capsular 1481 1482 effect due to variable and moderate injection volumes 1483 of anywhere from 8 mL to more than 20 mL and 1484 1485 without data describing mean injectate volumes or 1486 expected capsular effect. 1487 In addition to the continual capsular distension, im1488 1489 provements in patients receiving hydrodilatation with 1490 corticosteroid injection may be attributable to the 1491 1492 appropriate location of deliverance of corticosteroid. 1493 CP provides continual dilatation while ensuring that 1494 injected corticosteroid stays within the joint capsule, 1495 1496 where it can provide maximal anti-inflammatory ef1497 fects. With CR, there is fluid extravasation that carries 1498 1499 injected corticosteroid into the surrounding soft tissue, 1500 away from inflamed structures. In a recent case series 1501 by Yoon et al [32], patients receiving hydrodilatation 1502 1503 with corticosteroid injection and CP demonstrated 1504 marked improvement compared with previously pub1505 1506 lished results. Mean pain scores were 8.4 at baseline, 1507 3.4 at 24 hours, 3.1 at 48 hours, 2.1 at 2 weeks, and 1.9 1508 1509 Q8 at 4 months. The mean Oxford score was 13.6 at base1510 line and 36.5 at 4-month follow-up. The benefit seen 1511 with hydrodilatation with corticosteroid and CP in prior 1512 1513 studies and in the studies included in this review in1514 dicates that CP may result in superior pain relief and 1515 1516 clinical effect as measured by the Oxford score. This is 1517 in contrast to previous studies of hydrodilatation 1518 without corticosteroid injection that demonstrated su1519 1520 perior results with CR.

Injection approaches varied significantly among the 1521 1522 studies included in this review. This may account for 1523 some of the variability in outcomes, as previous cadav- 1524 eric [33], magnetic resonance imaging [34], and ultra- 1525 1526 sound [35] studies have shown that pathologically 1527 contracted structures in patients with adhesive capsu- 1528 1529 litis include the anterior capsule, most notably the 1530 coracohumeral ligament and the rotator cuff interval. 1531 Multiple approaches can been attempted to more 1532 1533 effectively target these pathological structures in pa- 1534 tients with adhesive capsulitis as, theoretically, tar- 1535 1536 geted increased pliability of anterior structures through 1537 local dilatation and deposition of corticosteroid may 1538 1539 provide optimal effect and, subsequently, clinical 1540 1541 improvement. Previously, Prestgard et al [36] studied the efficacy of 1542 1543 corticosteroid injections directly into the anterior gle- 1544 nohumeral capsule itself. This approach ensures that 1545 1546 corticosteroid is injected around the pathological 1547 structures, but demonstrated no benefit when 1548 compared to intra-articular corticosteroid injections 1549 1550 alone. The lack of additional benefit seen with the 1551 approach used by Prestgard et al [36] may be due to a 1552 1553 lack of dilational effects with small intra-articular vol- 1554 umes in the patient group receiving directed injections 1555 into the anterior capsule synovial tissue. For example, 1556 1557 in those receiving traditional intra-articular corticoste- 1558 roid injections, 7 mL was injected into the glenohumeral 1559 1560 joint, compared to those receiving anterior capsular 1561 injections, who had 3.5 mL injected into the gleno- 1562 1563 humeral joint and 3.5 mL into the anterior glenohumeral 1564 capsule synovial tissue. The combination of localized 1565 corticosteroid deposition into the anterior glenohumeral 1566 1567 capsule with simultaneous targeted dilatation of ante- 1568 rior capsular structures theoretically would have pro- 1569 1570 vided additional benefit over localized corticosteroid 1571 deposition into the anterior capsule. This theoretical 1572 benefit is demonstrated among studies in this review, 1573 1574 with improved clinical endpoints such as increased ROM 1575 and pain relief when effectively combining these 1576 1577 elements. 1578 Injection approaches among studies included in this 1579 review can be grouped into posterior approaches, direct 1580 1581 anterior approaches, and anterior-lateral approaches. 1582 Studies using an anterior fluoroscopy technique [21,23], 1583 1584 whereby the needle entered the joint at or below the 1585 medial humeral head, did not demonstrate significant 1586 1587 benefits at final follow-up compared to standard-of-care 1588 corticosteroid injection. As described by both Yoon et al 1589 [23] and Tveita et al [37], “during the injection, the 1590 1591 joint was gradually distended, making the axillary and 1592 subscapular recesses more visible,” demonstrating that Q91593 1594 pathologic structures experienced little to no disten- 1595 sion. This is in contrast to studies in this review that 1596 1597 used a posterior approach whereby the joint was 1598 accessed superiorly at the level of the scapular spine, 1599 and in which the patients demonstrated significant 1600

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benefit [20], trend toward benefit [19], or no benefit [24]. This approach allows for more target dilatation of the anterior-superior aspect, explaining some of the benefit experienced by these patients. This trend is supported Reza et al, who demonstrated significant maintained benefit of hydrodilatation with corticosteroid injection using an anterior-lateral approach under fluoroscopy [22]. This approach also accesses the joint in the superior aspect and theoretically results in targeted dilatation of anterior capsular structures. The use of control groups was not homogenous among studies. Control groups varied from a total injectate volume of 10 mL in Yoon et al [23] and Tveita et al [21] compared to 1 mL in Reza et al [22], Jacobs et al [19], and Gam et al [20]. This heterogeneity makes it difficult to compare between-study results, as patients receiving intra-articular injections of 10 mL likely experienced some amount of dilatation. In addition, this large volume does not translate to clinical practice, as the majority of glenohumeral corticosteroid injections are significantly below 10 mL. As such, 2 of the studies [21,23] reporting negative results may be confounded by the use of a control group that received clinically significant dilatation greater than seen with standard-ofcare intra-articular injections. Differences among patient populations may explain some of the variability seen among the studies in this review. Patients in the earlier stages of their condition have a predominantly inflammatory response with a pliable capsule amenable to dilatation and the antiinflammatory effects of corticosteroid. As such, patients who receive intervention earlier in the course of disease would be expected to experience greater clinical improvement. Although no study reported the proportion of patients in each stage of the disease, 2 studies with a mean symptom duration of 5 months reported increased improvement in the combined group, whereas studies with a mean symptom duration of more than 7 months demonstrated no benefit. Although there were a multitude of steroid types, dosages, varying numbers of injections, and cumulative hydrodilatation offered, we do not believe that these significantly contributed to the variability seen among studies in this review. This is because there have been several studies demonstrating benefit with varying amounts of corticosteroid injection [13,14,38] and no difference between high-dose and low-dose triamcinolone acetonide observed [16]. In addition, it is not believed that a cumulative dilatory effect played a role in the variability seen between trials, as previous studies have demonstrated no additional benefit of repeat hydrodilatation [39]. In addition, there was no trend found among those studies that offered repeat hydrodilatation compared to those that offered a single intervention. Of the 3 that offered repeat interventions, one demonstrated statistically significant benefit [20], one demonstrated only clinically apparent benefit [19],

11

and one demonstrated no benefit [21], compared to 3 studies that offered a single intervention, of which one demonstrated significant benefit [22] and 2 demonstrated no benefit [23,24]. It is theorized that the lack of additional benefit with repeat intervention is that the capsule in these patients had progressed to a point at which it was no longer amenable to either dilatation or anti-inflammatory medication, and repeat interventions could not overcome this. Side effects were equal among the combined intervention group and controls. Approximately 15% of patients in each group described transient loss of sensation, motor control of the arm, flushing, nausea, dizziness, pain, and/or discomfort. These were typically rated as mild and spontaneously resolved completely, lasting only for a short period of time. Dropout rates were low in all studies, with no differences between groups. This systematic review builds on the 2008 Cochrane Review [17] by further elucidating whether hydrodilatation with corticosteroid injection results in an expedited return of pain-free ROM compared to corticosteroid injection by the inclusion of recently published randomized controlled trials and refined trial inclusion with appropriate control groups. From this review, we can conclude that there is silver-level evidence that hydrodilatation with corticosteroid injection provides short-term improvements in pain-free ROM and functionality in the first 1-3 months, with unclear benefit in long-term outcomes. Conclusion Hydrodilatation with corticosteroid injection for adhesive capsulitis remains a theoretically attractive intervention due to its potential ability to simultaneously treat the pathologic inflammatory response and capsular contraction. However. there continues to be insufficient and conflicting evidence in the existing literature as to whether there is benefit to the addition of hydrodilatation to standard-of-care corticosteroid injection alone. The variability in published studies can be explained by the heterogeneity in injectate dose and volume, intended CP or rupture, approaches for injection, and presence or absence of appropriate control groups. There is evidence that optimization of technique may explain the synergistic effect experienced with hydrodilatation and corticosteroid injection in several studies. In the literature, there is a trend toward benefit of the addition of hydrodilatation to corticosteroid injection, specifically in studies that targeted tight anterior capsular structures. Despite the trend demonstrated in the literature, there remains a lack of robust data on the effect of hydrodilatation with corticosteroid injection via this optimized technique, as only a few studies have combined these factors. There has yet to be a consistent demonstration of benefit in a

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high-quality, published research study. Further research is warranted to better understand the factors affecting patient response to hydrodilatation with corticosteroid injection, and to provide reliable evidence on the effects of hydrodilatation with corticosteroid injection via an optimized technique. Hydrodilatation with corticosteroid injection has not been demonstrated to hinder improvement or to result in an increased prevalence of side effects compared to corticosteroid injection alone. Due to the limited quality of the available literature, adhesive capsulitis continues to pose a challenge for the treating physician in deciding the most appropriate intervention protocol. In conclusion, there is currently conflicting high-quality evidence that hydrodilatation with corticosteroid injection expedites the return of pain-free ROM compared to intra-articular corticosteroid injection alone.

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Disclosure M.C. Toronto Rehabilitation Institute, University Center, 550 University Ave, Toronto, ON M5G 2A2, Canada; Division of Physical Medicine and Rehabilitation, Department of Medicine, University of Toronto, Toronto, ON, Canada. Address correspondence to: M.C.; e-mail: [email protected] Disclosure: nothing to disclose N.M. Division of Physical Medicine and Rehabilitation, Department of Medicine, University of Toronto, Toronto, ON, Canada Disclosure: nothing to disclose J.A. University of Toronto Faculty of Medicine, University of Toronto, Toronto, ON, Canada Disclosure: nothing to disclose

D.K. Division of Physical Medicine and Rehabilitation, Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medicine, University of Toronto, Toronto, ON, Canada Disclosure: nothing to disclose H.S. Division of Physical Medicine and Rehabilitation, Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medicine, University of Toronto, Toronto, ON, Canada Disclosure: nothing to disclose Submitted for publication May 12, 2017; accepted October 25, 2017.

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