Treatment Effects of Ultrasound-Guided Capsular Distension With Hyaluronic Acid in Adhesive Capsulitis of the Shoulder

Archives of Physical Medicine and Rehabilitation journal homepage: www.archives-pmr.org Archives of Physical Medicine and Rehabilitation 2013;94:264-70

ORIGINAL ARTICLE

Treatment Effects of Ultrasound-Guided Capsular Distension With Hyaluronic Acid in Adhesive Capsulitis of the Shoulder Ki Deok Park, MD,a Hee-Seung Nam, MD,b Ju Kang Lee, MD, PhD,a Young Joo Kim, PhD,c Yongbum Park, MDc From the aDepartment of Rehabilitation Medicine, Gachon University of Medicine and Science, Gil Medical Center, Incheon; bDepartment of Physical Medicine and Rehabilitation, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul; and cDepartment of Physical Medicine and Rehabilitation, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea.

Abstract Objective: To investigate the efficacy of ultrasound-guided intra-articular (IA) hyaluronic acid injection with capsular distension compared with steroid injection alone in patients with adhesive capsulitis of the shoulder by assessing pain relief, functional improvements, and range of motion at 2 and 6 weeks after final injections. Design: Prospective randomized controlled trial. Setting: University hospital. Participants: Patients (NZ100) with adhesive capsulitis of shoulder. Interventions: Subjects were randomly assigned to 2 groups: 45 patients in group A were treated with 0.5% lidocaine plus triamcinolone 40mg IA injection and 45 patients in group B were treated with 0.5% lidocaine plus hyaluronic acid 20mg and capsular distension. All injections were performed every 2 weeks for a total of 3 times. Main Outcome Measures: Treatment effects were assessed using the Shoulder Pain and Disability Index (SPADI), Verbal Numeric Scale (VNS), and passive range of motion (ROM) of the shoulder (flexion, abduction, external rotation) before injections and at 2 and 6 weeks after the last injections. Results: SPADI, VNS, and passive ROM were improved at 2 and 6 weeks in both groups. The statistical differences were not observed in SPADI and VNS between groups (P<.05), and shoulder passive external rotation was more improved in group B than in group A (P<.05). Conclusions: Capsular distension with IA hyaluronic acid injection was shown to be a treatment method as effective as the steroid injection alone in pain relief and functional improvement; additionally, it was more effective in passive external rotation improvement than steroid injection alone. Archives of Physical Medicine and Rehabilitation 2013;94:264-70 ª 2013 by the American Congress of Rehabilitation Medicine

Adhesive capsulitis is one of the most common afflictions of the shoulder joint, with as much as 2% of the general population suffering from the affliction.1,2 It is characterized by spontaneous onset of pain and progressive stiffness of the glenohumeral joint, accompanied by significant disability.3,4 Ombregt5 reported that it is possible to recover to normative function using home-based therapies, moist heat, simple analgesics, and reassurance, whereas others have emphasized the importance of continuous treatment to prevent persistent pain, limitations of shoulder joint No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.

motion, and adverse effect on the activities of daily living, including sleep disturbance. In patients with severe pain or limitations in range of motion (ROM), physiotherapy, exercise, and oral medication are recommended. These can include intraarticular (IA) injections, capsular distension, manipulation after anesthesia, and surgery.5-7 However, manipulation after anesthesia and surgery are limited by poor accessibility; thus, the IA injections of drugs, such as corticosteroids, and capsular distension after IA injection are more commonly used. On the other hand, IA injection of corticosteroid may cause complications, such as fat atrophy, skin color changes, and weakness of ligaments or tendons caused by leakage of drugs into surrounding soft tissues.8

0003-9993/13/$36 - see front matter ª 2013 by the American Congress of Rehabilitation Medicine http://dx.doi.org/10.1016/j.apmr.2012.10.002

Hyaluronate and capsular distension It has recently been accepted that sodium hyaluronate injections are a safe and effective treatment method, especially for knee osteoarthritis.8 A 1-week interval is regarded as an ideal injection period, and the therapeutic effect generally begins after the second week injection.9-11 There are a few clinical studies of hyaluronic acid’s positive effect for the treatment of shoulder disease, including adhesive capsulitis.12-14 Arthrographic distension of the glenohumeral joint capsule leading to capsular rupture was first described as a potential treatment for painful stiff shoulder by Andren and Lundberg.15 Gam et al16 reported a significant improvement in ROM and analgesic use in the group treated with distension and steroids compared with steroids alone, but they reported no difference in pain. It is important that injections be made correctly, because incorrect placement can cause discomfort and significantly reduce treatment efficacy.8 The requirement for correct placement of a needle into IA space for capsular distension also enhances the importance of injection precision.15 Shoulder IA injection is usually performed with a fluoroscopy-guided anterior approach. However, deployment of ionizing radiation is a disadvantage. Interventions guided with an ultrasound (US) are found to be valuable, because the needle can be followed real-time during the procedure and no radiation is involved.17 Although IA injection of sodium hyaluronate is a treatment option in the management of adhesive capsulitis of the shoulder, its effect remains controversial. We hypothesized that a more accurate injection using US guidance and IA injection concurrent with capsular distension would result in positive effects in passive shoulder ROM and general clinical outcome measures and pain scales. To our knowledge, no study has yet compared the treatment efficacies of US-guided capsular distension with hyaluronic acid to steroid IA injections. The purpose of this study was to compare the treatment efficacies of IA steroid injection and capsular distension plus IA hyaluronic acid injection using US guidance in patients with adhesive capsulitis of the shoulder.

Methods After obtaining approval from the institutional review board and registering for a clinical trial, 100 patients complaining of shoulder pain and shoulder ROM limitations were enrolled into this prospective, randomized, blinded study. The study took place from June 1, 2010 to May 31, 2011. Diagnoses of adhesive capsulitis were performed by 2 physiatrists based on the patients’ medical history, physical examination, radiologic evaluation, and musculoskeletal ultrasonographic findings. Patients were assessed for eligibility according to the following criteria: a disease duration of 3 to 9 months and a reduction in passive ROM in at least 2 of the following: forward flexion, abduction, or external rotation (ER) of the affected shoulder of >30
compared with the contralateral side.18 The exclusion criteria applied were a US finding of a full thickness tear, massive tear of the rotator cuff, hospitalization over

List of abbreviations: ER IA ROM SPADI US VNS

external rotation intra-articular range of motion Shoulder Pain and Disability Index ultrasound Verbal Numeric Scale

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265 the previous 6 months because of a shoulder joint-related incident, severe psychiatric problem, aged under 19 or over 70 years, shoulder joint plain radiographic finding of significant glenohumeral joint arthritis, systematic rheumatic disease, neurologic disorder, such as cervical radiculopathy or stroke, bleeding tendency, the taking of anticoagulants, diabetes mellitus (associated with steroid side effects), history of side effects to local anesthetics, presence or suspicion of infection, or the taking of any drug (other than acetaminophen) during treatment or follow-up that might affect outcome results.9,18,19

Randomization of participants After documenting general patient characteristics, participants were randomly assigned into 1 of 2 groups using a computergenerated randomization table. Patients in group A were administered a mixture of 0.5% lidocaine (4mL) plus triamcinolone (40mg/mL; 1mL); group B was administered 0.5% lidocaine (18mL) for capsular distension with high molecular weight sodium hyaluronate (10mg/mL; 2mL). All patients received 3 USguided IA injections every 2 weeks (a total of 3 injections), and they were blinded to injection methods.

US-guided IA injection techniques All US-guided IA injections were performed by 2 physiatrists with over 7 years of relevant experience using an Accuvix XQa and a linear 6-12MHz probe. Patients were asked to sit on a chair without a backrest and lower the unaffected arm. The elbow joint was then flexed at approximately 90
and the forearm pronated (fig 1). The US probe was placed just below the spine of the scapular at the level of the glenohumeral joint. We used US-guided IA injections using the needle (23G, 7.5cm) by the posterior approach method (see fig 1).20 All injections were made after ensuring that the needle tip was properly located in the IA space by the US. The accuracy of injection into the IA space was checked during the procedure, and joint capsule distension was checked in appropriate cases. The patients were asked to limit shoulder motion for at least 10 minutes postinjection to allow localization of injected drugs in the articular capsule. Participants in both groups received a simple exercise program comprising a pendulum exercise and scapular setting (isometric scapular retraction). Additionally, acetaminophen with no antiinflammatory effect or ice massage was permitted if the patients complained of pain at the injection site.

Assessments of treatment effects The same blinded outcome assessor evaluated all patients at baseline and at 2 and 6 weeks after the final injections. Data collected at baseline included both personal and clinical characteristics, including duration, symptom severity, and previous treatment. Primary The primary outcome was the Shoulder Pain and Disability Index (SPADI), a self-administered assessment tool that measures pain and disability related to shoulder disease.21 It consists of 5 pain and 8 disability items that are measured on a visual analog scale. Pain and disability subscales were calculated as the mean of the corresponding items on a 0 to 100 scale; the highest score

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Fig 1 US-guided IA injection by the posterior approach. (A, B) Sono-guided IA injection by posterior approach. (C) Initial sono-guided IA injection at the glenohumeral joint. (D) After sono-guided injection with capsular distension (*). The white arrowhead is the needle. Abbreviations: HH, humeral head; L, labrum.

indicated the most severe pain and disability. The total score was calculated as the sum of the pain and disability subscales. The SPADI has been used in previous randomized trials investigating treatment effects in frozen shoulder populations.22-24 Psychometric properties of the index have been tested in shoulder patients and indicate acceptable validity for group comparisons.25-27 Secondary The Verbal Numeric Scale (VNS), passive ROM, and presence of a complication were secondary outcome measures. The VNS was obtained before injection and 2 and 12 weeks after the procedures in order to grade the treatment effects. When using the VNS, the

patients were asked to rate their pain on a scale from 0 to 10: 0 and 10 represented no pain and the worst pain possible, respectively.28 A medical investigator marked the scale for the patients incapable of marking for themselves by directing and slowly moving from 0 to 10 on a VNS scale board. The patients nodded at the appropriate score. ROM was measured in a supine position by physicians. One physician assisted the patient to achieve maximum passive motion, and the other measured passive ROM in 3 directions (forward flexion and abduction from neutral and ER from w45
of abduction) using a Dualer IQ inclinometer.b Measurements were repeated 3 times, and results are expressed as averages. www.archives-pmr.org

Hyaluronate and capsular distension

Statistical analysis The sample size was calculated based on reduction of the SPADI. A minimal clinical difference change of 10 was set from a previous study.29 However, the SD of this difference was not reported. We determined that a sample size of 45 participants in each group had 90% power to detect a difference in the mean SPADI scores 10, if the SD was 15.22 The target sample size required 50 patients in each group of the trial, allowing for a 10% attrition/noncompliance rate. Previous studies have identified 40 to 50 patients as acceptable.18,22,23 Chi-square and the Mann-Whitney U tests were used to compare the characteristics of 2 groups, such as sex, age, location, and duration of the disease. At each time point, the VNS, SPADI, and ROM were compared by repeated-measure analysis of variance, and Bonferroni adjustment was conducted for post hoc comparison. Statistics were performed with SAS Enterprise Guide 4.1 (4.1.0.471),c with a significance level of P<.05.

Results Patient flowchart One hundred and thirty-two patients were originally considered, and 100 were enrolled after excluding 32 for the following reasons: a US finding of a full thickness rotator cuff tear (nZ9) or a massive rotator cuff tear (nZ7), glenohumeral joint arthritis (nZ5), and refusal to participate (nZ11). In addition, group A (nZ5) and group B (nZ5) patients were excluded for the following reasons: peripheral injections (nZ7; hipZ2, kneeZ5) and administering medications other than acetaminophen (nZ3). Finally, 45 patients in group A and 45 patients in group B were included in the study (fig 2).

General characteristics of patients Group A consisted of 45 patients (mean age, 55.2y; mean disease period, 5.3mo; 12 men, 33 women), and group B consisted of 45 patients (mean age, 56.3y; mean disease period, 5.3mo; 10 men, 35 women). Group general characteristics were nonsignificantly different (P<.05) (table 1).

Treatment effects between the approaches Significant differences were not observed in the SPADI at preinjection and at 2 and 6 weeks after the procedures between the groups. The SPADI significantly improved at 2 and 6 weeks after the procedures in both groups (table 2). Significant differences were not observed in the VNS at preinjection and at 2 and 6 weeks after the procedures between the groups. The VNS score significantly decreased in 2 and 6 weeks after the procedures in both groups (table 3). Passive flexion, abduction, and ER improved significantly at 2 and 6 weeks after last injection, as compared with before injection in both groups (P<.05), and ER was significantly more improved in group B than in group A at 2 and 6 weeks (P<.05). However, there were no significant differences in passive flexion and abduction among the groups at 2 and 6 weeks (P<.05) (table 4). Two patients in group A and 1 patient in group B experienced pain because of needle contact to the labrum, and 12 patients in www.archives-pmr.org

267 group B reported pain during capsular distension. No severe complications, such as vasovagal syncope, allergic reactions, steroid-associated infection, adipose tissue atrophy, or toxic reactions, including dizziness, were observed after injections.

Discussion The role of inflammatory response in adhesive capsulitis remains debatable. Neviaser and Neviaser,30 for example, identified inflammation of the synovium and joint capsule using pathologic findings; they concluded that it accelerated capsular adhesion progression. Lundberg,2 however, concluded that inflammation has no significant effects. Nevertheless, many studies have shown that corticosteroid injections provide a therapeutic effect for adhesive capsulitis, and this method was commonly used until recently.7,31,32 When not correctly injected into the IA space, corticosteroid injections may cause several adverse effects.33-35 For this reason, IA hyaluronic acid was recently introduced for the treatment of adhesive capsulitis.10-14 Hyaluronic acid is known to improve the elastoviscosity of joint fluid by stimulating hyaluronan production by synoviocytes, which improves joint lubrication and shock absorbing ability.10 Hyaluronic acid also prevents matrix degradation, increases protein synthesis by chondrocytes, protects cartilage from damage by promoting proteoglycan agglutination, and induces a direct anti-inflammatory response in synovial fluid by blocking the production of prostaglandin E2 and inhibiting the release of arachidonic acid. Furthermore, it has been reported that these effects of hyaluronic acid make it effective for the treatment of adhesive capsulitis and glenohumeral joint degenerative arthritis.11-14 In particular, Sakurai et al36 suggested that high molecular hyaluronic acid provides an effective treatment for pain associated with adhesive capsulitis and joint adhesion. Calis et al,9 who compared hyaluronic acid IA injection with corticosteroid IA injection, physiotherapy, and exercise, also reported that hyaluronic acid provides an effective treatment for adhesive capsulitis of the shoulder. In addition to IA injection of corticosteroid alone or hyaluronic acid IA injection alone, adhesive capsulitis is also treated by capsular distension, during which most of the amount of mixed agents are injected into the affected shoulder joint space in order to separate the adhered joint capsule by hydraulic pressure. Furthermore, since 1989, when Fareed and Gallivan37 first reported the treatment benefits of capsular distension, this method has been widely used because of its cost and safety advantages, and because it provides immediate ROM improvements. Capsular distension decreases pressure within the articular capsule by rupturing articular capsule and expansion of the articular space, and thus this method is deemed appropriate when no improvement has been achieved using other methods over a 3-month period.7 Gam et al16 concluded that capsular distension provided greater shoulder motion improvement and reduced analgesic use in patients treated with IA corticosteroid injection and capsular distension than in patients treated with IA corticosteroid injection alone. In this study, we compared the functional scale, pain relief, and passive ROM improvements between groups. We found that both of the groups improved on the functional scale, pain, and passive ROM at 2 and 6 weeks postinjection. Furthermore, our results also showed no significant differences in passive flexion or abduction between the 2 groups after treatment, but showed more significant

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Fig 2

Patient flowchart.

improvement of passive ER in group B. Because Mao et al38 suggested that ER has much more association with an increase of joint space and capsular distension than any other shoulder motion, this improvement in passive ER may be because of a greater increase in joint space in this group. Despite treatment efficacy of IA corticosteroid observed in this study, its potential complications encourage consideration of IA hyaluronic acid in patients with diabetes mellitus or in those with a history of corticosteroid side effects. Although we found significant improvement of about 10
of shoulder ER in the hyaluronate Table 1

injection group compared with the corticosteroid injection group, there were no significant between-group differences in the SPADI, a functional scale that could represent clinical efficacy. Hyaluronate injection with other techniques, such as capsular distension and rupture, could yield more favorable results in ROM and functional improvement. A further study with other functional scales, other than the SPADI analysis, could present clinical importance of about 10
shoulder ER improvement. Previous studies on capsular distension have used local analgesics and corticosteroid, whereas, in the present study, we used lidocaine and hyaluronic acid. According to Tveita et al,18 the

Patient characteristics

Characteristic

Group A

Group B

Number of subjects Sex (male/female) Location (right/left) Age (y) Duration (mo)

45 12/33 31/14 55.234.69 5.311.64

45 10/35 33/12 56.335.92 5.333.62

NOTE. Values are mean  SD or as otherwise indicated. Abbreviations: Group A, 0.5% lidocaine (4mL) plus triamcinolone 40mg (1mL); group B: 0.5% lidocaine (18mL) plus high molecular weight sodium hyaluronate 20mg (2mL) plus capsular distension.

Table 2

SPADI of adhesive capsulitis pre- and postinjection

Group

Before Injection

2wk After Second Injection

6wk After Last Injection

Group A Group B

61.79.4 61.29.8

28.36.1* 26.07.7*

20.045.80* 21.906.80*

NOTE. Values are mean  SD. Abbreviations: Group A, 0.5% lidocaine (4mL) plus triamcinolone 40mg (1mL); group B: 0.5% lidocaine (18mL) plus high molecular weight sodium hyaluronate 20mg (2mL) plus capsular distension. * Significantly different from baseline (P<.05).

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Hyaluronate and capsular distension

269

Table 3

VNS of adhesive capsulitis pre- and postinjection

Group

Before Injection

2wk After Second Injection

6wk After Last Injection

Group A Group B

6.20.9 6.11.0

2.80.5* 3.00.6*

2.20.4* 2.30.5*

NOTE. Values are mean  SD. Abbreviations: Group A, 0.5% lidocaine (4mL) plus triamcinolone 40mg (1mL); group B: 0.5% lidocaine (18mL) plus high molecular weight sodium hyaluronate 20mg (2mL) plus capsular distension. * Significantly different from baseline (P<.05).

capsular distension caused by injecting 20cm3 causes capsular rupture in all cases; even 8-10cm3 caused capsular rupture in some cases. Based on these observations, it appears that capsular distension with corticosteroid could cause complications because of leakage of corticosteroid into proximal soft tissues after rupture, and that capsular distension with hyaluronic acid effectively improves symptoms and functions without corticosteroid. Four patients in the capsular distension plus IA hyaluronic acid group reported temporary pain during injection, but this group showed greatest improvement overall. Thus, despite the possibility of increased pain during the injection procedure, our findings indicate that this is an excellent treatment free of the complications associated with IA corticosteroid injection. In this study, US guidance was used to improve injection accuracy. Previous studies39,40 on blind shoulder IA injections, which are widely used in clinical settings, have reported accuracies ranging from 27% to 80%, depending on the approaches used. USs allow precise needle positioning within the small space within a millimeter accuracy, thus reducing injuries to adjacent structures and side effects related to the extra-articular instillation of medicaments. It also shortens the overall time of the procedure. Although fluoroscopy, computed tomography, and magnetic resonance imaging can be used as an alternative to US, these techniques are time-consuming, less handy, and involve radiation exposure or require a special needle.41 We believe that the results of this study are more reliable than those of previous blind IA injection-based studies, because a US-guided posterior approach method was used, drugs were injected after ensuring that the needle was placed under the labrum, and expansion of the articular capsule was confirmed during injection.

Table 4

Passive ROM of adhesive capsulitis pre- and postinjection

Before Movement Group Injection

2wk Postinjection

6 wk Postinjection

Flexion

140.113.3* 138.115.3* 106.714.4* 106.613.8* 42.97.6* 50.08.7*y

145.8012.80* 144.3015.20* 113.8512.90* 115.0012.90* 44.507.70* 56.008.00*y

A B Abduction A B ER A B

103.617.0 104.017.0 76.514.7 77.214.8 23.29.9 23.78.8

NOTE. Values are mean  SD. Abbreviations: Group A, 0.5% lidocaine (4mL) plus triamcinolone 40mg (1mL); group B: 0.5% lidocaine (18mL) plus high molecular weight sodium hyaluronate 20mg (2mL) plus capsular distension. * Significantly different from baseline (P<.05). y Significantly different between the groups (P<.05).

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Study limitations However, the present study has several limitations. First, participants and treatment effect assessor were blinded, but the injectors were not blinded to injection methods. It could bias our results. Second, although the significance level and power were considered in obtaining the number of patients, statistical results may have been limited by the number of cases, especially for the ROM observed. Third, small volume injection, even below 10cm3, can cause rupture of the joint capsule in adhesive capsulitis patients, but we did not make a confirmation of capsular rupture which cannot make a satisfactory effect of joint expansion.

Conclusions In this study, capsular distension with IA hyaluronic acid injection showed similar improvement in pain relief and function as the IA corticosteroid only injection, with the exception of better effects in passive ER. Therefore, we conclude that capsular distension with IA hyaluronic acid injection may be useful for patients with contraindication for using corticosteroid.

Suppliers a. Medison, Daechi-dong 1003, Gangnam-gu, Seoul, 135-280, Republic of Korea. b. JTECH Medical, 470 Lawndale Dr, Salt Lake City, UT 84115. c. SAS, 100 SAS Campus Dr, Cary, NC 27513-2414.

Keywords Adhesive capsulitis; Triamcinolone

Hyaluronic

acid;

Rehabilitation;

Corresponding author Yongbum Park, MD, Sanggye Paik Hospital, Inje University College of Medicine, 761-1, Sanggye-dong, Nowon-gu, Seoul 139-707, Korea. E-mail address: [email protected].

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