SHOULDER Intra-articular injection, subacromial injection, and hydrodilatation for primary frozen shoulder: a randomized clinical trial Jong Pil Yoon, MD a , Seok Won Chung, MD b, *, Ju-Eun Kim, MD a , Hyung Sup Kim, MD a , Hyun-Joo Lee, MD a , Won-Ju Jeong, MD a , Kyung-Soo Oh, MD b , Dong-Oh Lee, MD b , Anna Seo, PhD c , Youngjun Kim, PhD c a Department of Orthopaedic Surgery, School of Medicine, Kyungpook National University, Daegu, South Korea b Department of Orthopaedic Surgery, School of Medicine, Konkuk University, Seoul, South Korea c Center for Bionics, Korea Institute of Science and Technology, Seoul, South Korea Background: The aim of this prospective randomized study was to compare the efficacy of 3 injection methods, intra-articular injection, subacromial injection, and hydrodilatation (HD), in the treatment of primary frozen shoulder. Methods: Patients with primary frozen shoulder were randomized to undergo intra-articular injection (n = 29), subacromial injection (n = 29), or HD (n = 28). Evaluations using a visual analog scale for pain, Simple Shoulder Test, Constant score, and passive range of shoulder motion were completed before treatment and 1 month, 3 months, and 6 months after treatment. Results: Among the 3 injection methods for primary frozen shoulder, HD resulted in a greater range of motion in forward flexion and external rotation, a lower visual analog scale score for pain after 1 month, and better outcomes for all functional scores after 1 month and 3 months of follow-up. However, there were no sig- nificant differences in any clinical outcomes among the 3 groups in the final follow-up at 6 months. Conclusions: Although HD yielded more rapid improvement, the 3 injection methods for primary frozen shoulder resulted in similar clinical improvement in the final follow-up at 6 months. Level of evidence: Level I; Randomized Controlled Trial; Treatment Study © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees Keywords: Primary frozen shoulder; stiff shoulder; injection method; intra-articular injection; subacromial injection; hydrodilatation Frozen shoulder (adhesive capsulitis) is a common disease that restricts passive and active range of motion (ROM) in the glenohumeral (GH) joint. The concept was initially de- veloped by Codman and Neviaser. 12 Frozen shoulder accounts for approximately 2% to 5% of all cases of shoulder pain. 3,6,28 Frozen shoulder consists of 3 sequential phases or stages: in- flammatory, freezing, and thawing. The condition may persist for 1 to 3 years, and it can be self-limited. 17 Unfortunately, This research was supported in part by the KIST institutional program (2E25250). The Institutional Review Board of Kyungpook National University Hospi- tal approved this study (No. KNUH 2013-01-006). Written informed consent was obtained from all patients. *Reprint requests: Seok Won Chung, MD, Department of Orthopaedic Surgery, Konkuk University School of Medicine, 120-1 Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul 143-729, South Korea. E-mail address: [email protected] (S.W. Chung). www.elsevier.com/locate/ymse 1058-2746/$ - see front matter © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees http://dx.doi.org/10.1016/j.jse.2015.11.009 J Shoulder Elbow Surg (2016) 25, 376–383
Intra-articular injection, subacromial injection, and hydrodilatation for primary frozen shoulder: a randomized clinical trial
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Intra-articular injection, subacromial injection, and hydrodilatation for primary frozen shoulder: a randomized clinical trialIntra-articular injection, subacromial injection, and hydrodilatation for primary frozen shoulder: a randomized clinical trial
Jong Pil Yoon, MDa, Seok Won Chung, MDb,*, Ju-Eun Kim, MDa, Hyung Sup Kim, MDa, Hyun-Joo Lee, MDa, Won-Ju Jeong, MDa, Kyung-Soo Oh, MDb, Dong-Oh Lee, MDb, Anna Seo, PhDc, Youngjun Kim, PhDc
aDepartment of Orthopaedic Surgery, School of Medicine, Kyungpook National University, Daegu, South Korea bDepartment of Orthopaedic Surgery, School of Medicine, Konkuk University, Seoul, South Korea cCenter for Bionics, Korea Institute of Science and Technology, Seoul, South Korea
Background: The aim of this prospective randomized study was to compare the efficacy of 3 injection methods, intra-articular injection, subacromial injection, and hydrodilatation (HD), in the treatment of primary frozen shoulder. Methods: Patients with primary frozen shoulder were randomized to undergo intra-articular injection (n = 29), subacromial injection (n = 29), or HD (n = 28). Evaluations using a visual analog scale for pain, Simple Shoulder Test, Constant score, and passive range of shoulder motion were completed before treatment and 1 month, 3 months, and 6 months after treatment. Results: Among the 3 injection methods for primary frozen shoulder, HD resulted in a greater range of motion in forward flexion and external rotation, a lower visual analog scale score for pain after 1 month, and better outcomes for all functional scores after 1 month and 3 months of follow-up. However, there were no sig- nificant differences in any clinical outcomes among the 3 groups in the final follow-up at 6 months. Conclusions: Although HD yielded more rapid improvement, the 3 injection methods for primary frozen shoulder resulted in similar clinical improvement in the final follow-up at 6 months. Level of evidence: Level I; Randomized Controlled Trial; Treatment Study © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees
Keywords: Primary frozen shoulder; stiff shoulder; injection method; intra-articular injection; subacromial injection; hydrodilatation
This research was supported in part by the KIST institutional program (2E25250). The Institutional Review Board of Kyungpook National University Hospi- tal approved this study (No. KNUH 2013-01-006). Written informed consent was obtained from all patients.
*Reprint requests: Seok Won Chung, MD, Department of Orthopaedic Surgery, Konkuk University School of Medicine, 120-1 Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul 143-729, South Korea.
E-mail address: [email protected] (S.W. Chung).
1058-2746/$ - see front matter © 2016 Journal of Shoulder and Elbow Surger http://dx.doi.org/10.1016/j.jse.2015.11.009
Frozen shoulder (adhesive capsulitis) is a common disease that restricts passive and active range of motion (ROM) in the glenohumeral (GH) joint. The concept was initially de- veloped by Codman and Neviaser.12 Frozen shoulder accounts for approximately 2% to 5% of all cases of shoulder pain.3,6,28
Frozen shoulder consists of 3 sequential phases or stages: in- flammatory, freezing, and thawing. The condition may persist for 1 to 3 years, and it can be self-limited.17 Unfortunately,
y Board of Trustees
most patients with frozen shoulder reportedly do not regain full ROM irrespective of the treatment modality employed.10,27
Moreover, despite the availability of various treatments for frozen shoulder, an optimal treatment has not yet been established.21 The primary treatment methods for frozen shoul- der include medication5 and physical rehabilitation.18,20
However, if these fail, several injection methods, such as intra- articular injection (IAI), subacromial injection (SAI), or injection with hydrodilatation (HD), may be employed effectively1,4,7,13,26,33 before consideration of more aggressive treatments, such as manipulation under anesthesia11,14 or sur- gical release.2,15
IAI can decrease pain and thereby help improve ROM of the GH joint in patients with frozen shoulder, but it is tech- nically more difficult to perform than SAI.7 SAI is relatively easy to perform, and it does not require radiologic guid- ance. HD, or arthrographic distention of the shoulder joint, induces capsular rupture by introducing a fluid into the GH joint, resulting in increased shoulder joint motion. It was in- troduced as an injection treatment modality for frozen shoulder by Andren and Lundberg.1 It is known to be relatively safe and cost-effective, and it can elicit a rapid and satisfactory outcome.13 However, the evidence is insufficient to con- clude which injection method is superior among IAI, SAI, and HD for the treatment of frozen shoulder.
Thus, we designed a prospective, randomized study to compare treatment outcomes using IAI, SAI, and HD in pa- tients with primary frozen shoulder. The aim of this study was to identify which treatment modality is superior in terms of the visual analog scale (VAS) score for pain as well as func- tional outcomes, including ROM. We hypothesized that HD would provide superior clinical improvement compared with IAI and SAI.
Methods
Sample size calculation and patient allocation
This was a randomized, prospective, controlled study. We con- ducted this study in accordance with the principles of the Declaration of Helsinki. The reporting of data from this trial complies with the Consolidated Standards of Reporting Trials (CONSORT) statement.
Sample sizes were calculated to detect a 20% difference among the groups in the VAS score for pain on the basis of the pilot study and previous literature.30 A sample size of 30 patients in each group was required for a power of 90% at a type I error level of .05, with an expected dropout rate of 20%.
A total of 164 consecutive patients with primary frozen shoulder were prospectively enrolled between June 2012 and September 2013. Patients were diagnosed with frozen shoul- der if they had limitations of both active and passive shoulder motion and more severe pain at night than during the day and if findings on radiography of their shoulders were normal.24
Patients were eligible for the study if their shoulder symp-
toms (pain or discomfort) were present for 6 months to 1 year, if they had a VAS score of <7 of 10 for pain4 (thus probably in the freezing stage rather than in the inflammatory stage10), and if they remained unresponsive to conservative treat- ment consisting of medication or physical therapy for at least 6 months. All patients had limited active and passive ROM in at least 2 directions (abduction and forward flexion <100°, external rotation <20°, or internal rotation <L3).31 All pa- tients underwent simple radiography and sonography. Patients with secondary causes of frozen shoulder such as rotator cuff tear (n = 32) or calcific tendinitis (n = 9), those with GH ar- thritis (n = 4), those with a history of surgery on the same shoulder (n = 1), those who received a steroid injection within 6 months before enrollment (n = 23), and those who refused to participate in the study (n = 5) were excluded. No patient had a history of previous shoulder trauma, manipulation under anesthesia, or suprascapular nerve injection, and none had a worker’s compensation status. The remaining 90 patients were randomly allocated into the IAI, SAI, or HD group (30 pa- tients in each group). Patients were randomized using a computer-generated block randomization sequence (www.randomizer.org) by an independent researcher, and the group assignment was disclosed to the physician at the time of intended treatment.
Among these 90 patients, 4 (1 from the IAI group, 1 from the SAI group, and 2 from the HD group) were lost to follow- up. Accordingly, 86 patients (26 men, 60 women; mean age, 54.5 years [standard deviation, 8.3]) with primary frozen shoul- der (idiopathic adhesive capsulitis) were ultimately enrolled in this study (Fig. 1). The demographic and clinical data did not differ among the groups (all P < .05), and these data are summarized in Table I. During the study period, all patients underwent conventional conservative treatment, including med- ication and a home-based physical therapy exercise program. The medication included a nonsteroidal anti-inflammatory drug and muscle relaxant, which were administered for approxi- mately 4 weeks. For physical therapy, active assisted ROM exercise, including stick exercise, was performed for approx- imately 10 weeks, depending on the recovery of ROM. We employed a 4-quadrant stretching program (passive flexion, horizontal adduction, internal rotation behind the back with the unaffected arm, and external rotation at the side using a stick) to stretch the entire capsule at least 3 times a day (10- 15 minutes per session). When ROM had recovered, muscle- strengthening exercise was performed on the scapular stabilizers (such as the lower trapezius and serratus anterior muscles) and rotator cuff using a resistance band at least 3 times a day (10-15 minutes per session).
Clinical variables
All data were prospectively collected by a clinical re- searcher (A.-S.C.) who was blinded to the study design. The patients’ demographic data and other characteristics, includ- ing age, sex, symptom duration, dominant shoulder, underlying
Table I Patients’ demographic variables by injection group
Variable IAI SAI HD P value
No. 29 29 28 Age, years 53 (8) 57 (7) 54 (9) .137 Sex (M:F) 11:18 6:23 9:19 .347 Symptom duration, months 9 (6) 9 (5) 9 (6) .903 Dominant shoulder (yes:no) 16:13 17:12 14:14 .806 Diabetes (yes:no) 4:25 3:26 5:23 .715 Hypertension (yes:no) 7:22 6:23 6:22 .946 Heart disease (yes:no) 3:26 1:28 2:26 .587 Thyroid disease (yes:no) 1:28 1:28 2:26 .748 Smoking (yes:no) 7:22 4:25 5:23 .595 Work level (low:medium:high) 5:10:14 6:3:20 3:6:19 .199 Level of sports activity (high:moderate:low) 3:6:20 3:7:19 1:4:23 .665 Overhead sports (yes:no) 3:26 5:24 2:26 .476
IAI, intra-articular injection; SAI, subacromial injection; HD, hydrodilatation. Values in parentheses are standard deviations.
378 J.P. Yoon et al.
Injections for frozen shoulder 379
disease (diabetes mellitus, hypertension, heart disease, and thyroid disease), and smoking habits, were recorded. The level of sports activity was defined as high (dynamic or contact sports, such as boxing, basketball, rugby, and tennis), medium (static sports, such as yoga and jogging), or low (mild or no sports activity).8 The work level was defined as high, medium, or low, depending on whether the work involved heavy manual labor, manual labor with less physical activity, or sedentary activity, respectively.9
Treatment procedure
IAI group For IAI, an anterior approach was used with a 10-mL syringe and 21-gauge needle, and the procedure was performed with the patient in the supine position. Povidone sterilization was performed around the injection site, and the skin was anes- thetized with 2% lidocaine before injection, followed by IAI under sonographic guidance. The needle was placed imme- diately medial to the head of the humerus and approximately 1 cm lateral to the coracoid process, and it was directed pos- teriorly as well as slightly superiorly and laterally under sonographic guidance. If the needle struck against bone, it was retracted and redirected at a slightly different angle. When resistance was felt on penetrating the joint capsule, aspira- tion was performed to ensure that the needle was not placed in a blood vessel. Then, a mixture of 1 mL of triamcinolone (40 mg), 4 mL of 2% lidocaine, and 5 mL of normal saline was injected into the GH joint space slowly and with con- sistent pressure under sonographic guidance. We chose 40 mg of triamcinolone for evaluating the treatment effect on the basis of previous literature.26
SAI group For SAI, a posterior approach was used with a 10-mL syringe and 21-gauge needle, as described for the IAI group, and the procedure was performed with the patient in the sitting po- sition with the arm resting comfortably at the side and with the clinician standing behind the patient. After povidone ap- plication and skin anesthesia as described for the IAI group, the needle was inserted 2 to 3 cm inferior to the posterolat- eral corner of the acromion and directed anteriorly in the direction of the coracoid process under sonographic guid- ance. After verification by aspiration that the needle was not placed in a blood vessel, a mixture of 1 mL of triamcino- lone (40 mg), 4 mL of 2% lidocaine, and 5 mL of normal saline, as described for the IAI group, was injected slowly and with consistent pressure under sonographic guidance.
HD group For HD, an anterior approach was used with a 50-mL syringe and 21-gauge needle, and the procedure was performed with the patient in the supine position under overhead fluorosco- py in the operating room. Under fluoroscopy, the GH joint was identified and marked on the skin with a pen. After po- vidone sterilization, draping, and skin anesthesia, the needle
was placed immediately medial to the head of the humerus and approximately 1 cm lateral to the coracoid process, and it was directed posteriorly, slightly superiorly, and laterally, as described for the IAI group. The needle position was veri- fied by fluoroscopy. After aspiration and the injection of 4 mL of contrast medium for joint space confirmation, a mixture of 1 mL of triamcinolone (40 mg), 4 mL of local anesthetic (2% lidocaine), and 40 mL of normal saline was injected into the GH joint slowly and with pressure. When resistance was encountered, the injection was stopped momentarily and then continued. During the injection, the joint was gradually dis- tended, making the axillary and subscapular recesses more visible. The injection was continued until rupture of the capsule occurred. The capsule primarily ruptured in the wall of the subscapular recess or sometimes in the wall of the bicipital or axillary recess.29 The capsular rupture appeared as a loss of resistance, with leakage of contrast material on fluoroscopy.
All patients in the 3 groups received the same nonsteroi- dal anti-inflammatory drug for pain relief after injection. A stretching exercise program, as described previously, was started from the first day after injection.
Outcome evaluation
Clinical symptoms were evaluated at 4 time points for all pa- tients: before treatment and 1 month, 3 months, and 6 months after treatment. We set 6 months as the final follow-up eval- uation period because this period should be adequate to assess the result of the injection treatments and to decide on a sub- sequent treatment plan for a frozen shoulder. The clinical outcome was evaluated using the VAS score for pain (range, 0-10, with 10 indicating the worst pain), Simple Shoulder Test (SST), Constant score, and passive shoulder ROM.
Passive shoulder ROM was measured using a goniom- eter by a clinical researcher (A.-S.C.) who was blinded to the study. Forward elevation was measured in degrees between the arm and thorax in the scapular plane. External rotation at the side was measured in degrees between the thorax and forearm, with the arm held in an adducted position at 90° of elbow flexion. Internal rotation at the back was measured by the vertebral level reached with the tip of the thumb and num- bered serially 1 to 12 for the first to twelfth thoracic vertebrae, 13 to 17 for the first to fifth lumbar vertebrae, and 18 for any level below the sacral region.22
Statistical analysis
Statistical analysis was performed using SPSS 22.0 soft- ware (IBM, Armonk, NY, USA). Repeated-measures 1-way analysis of variance and post hoc Scheffé multiple compar- ison tests were used to identify significant differences in continuous variables among the groups; the χ 2 or Fisher exact test was used to identify any significant differences in cate- gorical variables. Before the analysis of variance test, the Kolmogorov-Smirnov test for normality and Levene test for
Table II Clinical scores by injection method
Variable VAS score for pain Simple Shoulder Test Constant score
IAI SAI HD IAI SAI HD IAI SAI HD
Preinjection 5.6 (2.1) 5.4 (2.6) 5.8 (1.5) 3.2 (1.8) 3.2 (2.9) 3.2 (2.2) 58.6 (17.1) 54.8 (17.1) 57.4 (20.0) 1 month 4.6 (1.1)* 4.2 (1.7) 3.6 (1.3)* 6.0 (2.5)* 6.1 (2.6)† 7.8 (2.0)*† 67.4 (19.8)* 64.2 (23.3) 78.1 (16.8)* 3 months 4.4 (1.5) 4.2 (1.8) 3.4 (1.4) 6.8 (1.6)* 6.0 (3.4)† 8.7 (3.4)*† 73.7 (18.1)* 64.8 (16.4) 77.3 (18.1)* 6 months 1.9 (1.1) 2.8 (1.6) 2.1 (1.3) 9.1 (1.2) 8.3 (2.8) 8.9 (1.2) 80.1 (14.2) 77.1 (17.6) 85.1 (11.2)
IAI, intra-articular injection; SAI, subacromial injection; HD, hydrodilatation. Values in parentheses are standard deviations. * Statistically significant difference (P < .05) between the HD group and IAI group. † Statistically significant difference (P < .05) between the HD group and SAI group.
The HD group showed a significantly lower VAS score for pain than the IAI group (P = .035) only at 1 month, a higher Simple Shoulder Test score than both the IAI group (P = .02 at 1 month and P = .05 at 3 months) and SAI group (P = .04 at 1 month and P = .004 at 3 months), and a higher Constant score than the IAI group (P = .039 at 1 month and P = .032 at 3 months). No differences between groups were found at 6 months.
380 J.P. Yoon et al.
homogeneity of variances were performed, and the assump- tion of normality and homogeneity of variances was fulfilled, all with P values > .05. The primary end point was the VAS score for pain, and the secondary end points were clinical scores and shoulder ROM. Values of P < .05 were consid- ered statistically significant.
Results
At the initial presentation, no intergroup differences were observed in the VAS score, SST, Constant score, and any ROM measure among the 3 groups. Each group displayed significant improvements from baseline to 6 months of follow-up (all P < .001). Every patient in each group was satisfied with his or her results at 6 months, and no patients required an additional treatment, such as manipulation or capsular release.
The VAS score for pain after 1 month of follow-up was significantly improved in the HD group compared with the IAI group (P = .035). However, at 3 and 6 months of follow- up, there were no statistically significant differences among the groups in the VAS score for pain (Table II).
For functional scores, at 1 month, the HD group exhib- ited a significant improvement in the SST compared with the IAI and SAI groups (P = .02 and .04, respectively) and a sig- nificant improvement in the Constant score compared with the SAI group (P = .039). At 3 months, the HD group had a significantly improved SST compared with the IAI and SAI groups (P = .05 and .004, respectively) and a significantly im- proved Constant score compared with the SAI group (P = .032). However, at 6 months, there were no significant differences in the SST or Constant score among the groups (all P > .05).
For ROM, at 1 month, the HD group experienced greater improvement in forward flexion (P = .009 and .007, respec- tively) and external rotation (P = .005 and .005, respectively) than the IAI and SAI groups (Table III). However, at 3 and 6 months, there were no significant differences among the groups in any ROM measure.
No patients exhibited steroid injection–related major com- plications, such as joint infection, permanent neurogenic symptoms, or steroid-induced arthritis. Several mild adverse effects were reported. Two patients in the IAI group and 1 patient in the SAI group complained of temporary mild diz- ziness and nausea after the injection. One patient in the HD group reported transient loss of sensation and motor control in the injected arm for a few hours after the injection, but these symptoms recovered without sequelae. One other patient in the HD group reported transient hypotensive syncope imme- diately after the injection, but the patient fully recovered after several minutes.
Discussion
The aim of this prospective randomized comparative trial was to evaluate whether 1 of the 3 injection methods for primary frozen shoulder was superior to the others. Steroid injection for the treatment of frozen shoulder has been widely used as a safe and effective treatment modality for pain relief.26,33 It may be used when medication or physical therapy exercise fails to relieve the symptoms of frozen shoulder before con- sideration of more traumatic or invasive treatments, such as manipulation under anesthesia or surgical capsular release.15
Three injection methods,…
Jong Pil Yoon, MDa, Seok Won Chung, MDb,*, Ju-Eun Kim, MDa, Hyung Sup Kim, MDa, Hyun-Joo Lee, MDa, Won-Ju Jeong, MDa, Kyung-Soo Oh, MDb, Dong-Oh Lee, MDb, Anna Seo, PhDc, Youngjun Kim, PhDc
aDepartment of Orthopaedic Surgery, School of Medicine, Kyungpook National University, Daegu, South Korea bDepartment of Orthopaedic Surgery, School of Medicine, Konkuk University, Seoul, South Korea cCenter for Bionics, Korea Institute of Science and Technology, Seoul, South Korea
Background: The aim of this prospective randomized study was to compare the efficacy of 3 injection methods, intra-articular injection, subacromial injection, and hydrodilatation (HD), in the treatment of primary frozen shoulder. Methods: Patients with primary frozen shoulder were randomized to undergo intra-articular injection (n = 29), subacromial injection (n = 29), or HD (n = 28). Evaluations using a visual analog scale for pain, Simple Shoulder Test, Constant score, and passive range of shoulder motion were completed before treatment and 1 month, 3 months, and 6 months after treatment. Results: Among the 3 injection methods for primary frozen shoulder, HD resulted in a greater range of motion in forward flexion and external rotation, a lower visual analog scale score for pain after 1 month, and better outcomes for all functional scores after 1 month and 3 months of follow-up. However, there were no sig- nificant differences in any clinical outcomes among the 3 groups in the final follow-up at 6 months. Conclusions: Although HD yielded more rapid improvement, the 3 injection methods for primary frozen shoulder resulted in similar clinical improvement in the final follow-up at 6 months. Level of evidence: Level I; Randomized Controlled Trial; Treatment Study © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees
Keywords: Primary frozen shoulder; stiff shoulder; injection method; intra-articular injection; subacromial injection; hydrodilatation
This research was supported in part by the KIST institutional program (2E25250). The Institutional Review Board of Kyungpook National University Hospi- tal approved this study (No. KNUH 2013-01-006). Written informed consent was obtained from all patients.
*Reprint requests: Seok Won Chung, MD, Department of Orthopaedic Surgery, Konkuk University School of Medicine, 120-1 Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul 143-729, South Korea.
E-mail address: [email protected] (S.W. Chung).
1058-2746/$ - see front matter © 2016 Journal of Shoulder and Elbow Surger http://dx.doi.org/10.1016/j.jse.2015.11.009
Frozen shoulder (adhesive capsulitis) is a common disease that restricts passive and active range of motion (ROM) in the glenohumeral (GH) joint. The concept was initially de- veloped by Codman and Neviaser.12 Frozen shoulder accounts for approximately 2% to 5% of all cases of shoulder pain.3,6,28
Frozen shoulder consists of 3 sequential phases or stages: in- flammatory, freezing, and thawing. The condition may persist for 1 to 3 years, and it can be self-limited.17 Unfortunately,
y Board of Trustees
most patients with frozen shoulder reportedly do not regain full ROM irrespective of the treatment modality employed.10,27
Moreover, despite the availability of various treatments for frozen shoulder, an optimal treatment has not yet been established.21 The primary treatment methods for frozen shoul- der include medication5 and physical rehabilitation.18,20
However, if these fail, several injection methods, such as intra- articular injection (IAI), subacromial injection (SAI), or injection with hydrodilatation (HD), may be employed effectively1,4,7,13,26,33 before consideration of more aggressive treatments, such as manipulation under anesthesia11,14 or sur- gical release.2,15
IAI can decrease pain and thereby help improve ROM of the GH joint in patients with frozen shoulder, but it is tech- nically more difficult to perform than SAI.7 SAI is relatively easy to perform, and it does not require radiologic guid- ance. HD, or arthrographic distention of the shoulder joint, induces capsular rupture by introducing a fluid into the GH joint, resulting in increased shoulder joint motion. It was in- troduced as an injection treatment modality for frozen shoulder by Andren and Lundberg.1 It is known to be relatively safe and cost-effective, and it can elicit a rapid and satisfactory outcome.13 However, the evidence is insufficient to con- clude which injection method is superior among IAI, SAI, and HD for the treatment of frozen shoulder.
Thus, we designed a prospective, randomized study to compare treatment outcomes using IAI, SAI, and HD in pa- tients with primary frozen shoulder. The aim of this study was to identify which treatment modality is superior in terms of the visual analog scale (VAS) score for pain as well as func- tional outcomes, including ROM. We hypothesized that HD would provide superior clinical improvement compared with IAI and SAI.
Methods
Sample size calculation and patient allocation
This was a randomized, prospective, controlled study. We con- ducted this study in accordance with the principles of the Declaration of Helsinki. The reporting of data from this trial complies with the Consolidated Standards of Reporting Trials (CONSORT) statement.
Sample sizes were calculated to detect a 20% difference among the groups in the VAS score for pain on the basis of the pilot study and previous literature.30 A sample size of 30 patients in each group was required for a power of 90% at a type I error level of .05, with an expected dropout rate of 20%.
A total of 164 consecutive patients with primary frozen shoulder were prospectively enrolled between June 2012 and September 2013. Patients were diagnosed with frozen shoul- der if they had limitations of both active and passive shoulder motion and more severe pain at night than during the day and if findings on radiography of their shoulders were normal.24
Patients were eligible for the study if their shoulder symp-
toms (pain or discomfort) were present for 6 months to 1 year, if they had a VAS score of <7 of 10 for pain4 (thus probably in the freezing stage rather than in the inflammatory stage10), and if they remained unresponsive to conservative treat- ment consisting of medication or physical therapy for at least 6 months. All patients had limited active and passive ROM in at least 2 directions (abduction and forward flexion <100°, external rotation <20°, or internal rotation <L3).31 All pa- tients underwent simple radiography and sonography. Patients with secondary causes of frozen shoulder such as rotator cuff tear (n = 32) or calcific tendinitis (n = 9), those with GH ar- thritis (n = 4), those with a history of surgery on the same shoulder (n = 1), those who received a steroid injection within 6 months before enrollment (n = 23), and those who refused to participate in the study (n = 5) were excluded. No patient had a history of previous shoulder trauma, manipulation under anesthesia, or suprascapular nerve injection, and none had a worker’s compensation status. The remaining 90 patients were randomly allocated into the IAI, SAI, or HD group (30 pa- tients in each group). Patients were randomized using a computer-generated block randomization sequence (www.randomizer.org) by an independent researcher, and the group assignment was disclosed to the physician at the time of intended treatment.
Among these 90 patients, 4 (1 from the IAI group, 1 from the SAI group, and 2 from the HD group) were lost to follow- up. Accordingly, 86 patients (26 men, 60 women; mean age, 54.5 years [standard deviation, 8.3]) with primary frozen shoul- der (idiopathic adhesive capsulitis) were ultimately enrolled in this study (Fig. 1). The demographic and clinical data did not differ among the groups (all P < .05), and these data are summarized in Table I. During the study period, all patients underwent conventional conservative treatment, including med- ication and a home-based physical therapy exercise program. The medication included a nonsteroidal anti-inflammatory drug and muscle relaxant, which were administered for approxi- mately 4 weeks. For physical therapy, active assisted ROM exercise, including stick exercise, was performed for approx- imately 10 weeks, depending on the recovery of ROM. We employed a 4-quadrant stretching program (passive flexion, horizontal adduction, internal rotation behind the back with the unaffected arm, and external rotation at the side using a stick) to stretch the entire capsule at least 3 times a day (10- 15 minutes per session). When ROM had recovered, muscle- strengthening exercise was performed on the scapular stabilizers (such as the lower trapezius and serratus anterior muscles) and rotator cuff using a resistance band at least 3 times a day (10-15 minutes per session).
Clinical variables
All data were prospectively collected by a clinical re- searcher (A.-S.C.) who was blinded to the study design. The patients’ demographic data and other characteristics, includ- ing age, sex, symptom duration, dominant shoulder, underlying
Table I Patients’ demographic variables by injection group
Variable IAI SAI HD P value
No. 29 29 28 Age, years 53 (8) 57 (7) 54 (9) .137 Sex (M:F) 11:18 6:23 9:19 .347 Symptom duration, months 9 (6) 9 (5) 9 (6) .903 Dominant shoulder (yes:no) 16:13 17:12 14:14 .806 Diabetes (yes:no) 4:25 3:26 5:23 .715 Hypertension (yes:no) 7:22 6:23 6:22 .946 Heart disease (yes:no) 3:26 1:28 2:26 .587 Thyroid disease (yes:no) 1:28 1:28 2:26 .748 Smoking (yes:no) 7:22 4:25 5:23 .595 Work level (low:medium:high) 5:10:14 6:3:20 3:6:19 .199 Level of sports activity (high:moderate:low) 3:6:20 3:7:19 1:4:23 .665 Overhead sports (yes:no) 3:26 5:24 2:26 .476
IAI, intra-articular injection; SAI, subacromial injection; HD, hydrodilatation. Values in parentheses are standard deviations.
378 J.P. Yoon et al.
Injections for frozen shoulder 379
disease (diabetes mellitus, hypertension, heart disease, and thyroid disease), and smoking habits, were recorded. The level of sports activity was defined as high (dynamic or contact sports, such as boxing, basketball, rugby, and tennis), medium (static sports, such as yoga and jogging), or low (mild or no sports activity).8 The work level was defined as high, medium, or low, depending on whether the work involved heavy manual labor, manual labor with less physical activity, or sedentary activity, respectively.9
Treatment procedure
IAI group For IAI, an anterior approach was used with a 10-mL syringe and 21-gauge needle, and the procedure was performed with the patient in the supine position. Povidone sterilization was performed around the injection site, and the skin was anes- thetized with 2% lidocaine before injection, followed by IAI under sonographic guidance. The needle was placed imme- diately medial to the head of the humerus and approximately 1 cm lateral to the coracoid process, and it was directed pos- teriorly as well as slightly superiorly and laterally under sonographic guidance. If the needle struck against bone, it was retracted and redirected at a slightly different angle. When resistance was felt on penetrating the joint capsule, aspira- tion was performed to ensure that the needle was not placed in a blood vessel. Then, a mixture of 1 mL of triamcinolone (40 mg), 4 mL of 2% lidocaine, and 5 mL of normal saline was injected into the GH joint space slowly and with con- sistent pressure under sonographic guidance. We chose 40 mg of triamcinolone for evaluating the treatment effect on the basis of previous literature.26
SAI group For SAI, a posterior approach was used with a 10-mL syringe and 21-gauge needle, as described for the IAI group, and the procedure was performed with the patient in the sitting po- sition with the arm resting comfortably at the side and with the clinician standing behind the patient. After povidone ap- plication and skin anesthesia as described for the IAI group, the needle was inserted 2 to 3 cm inferior to the posterolat- eral corner of the acromion and directed anteriorly in the direction of the coracoid process under sonographic guid- ance. After verification by aspiration that the needle was not placed in a blood vessel, a mixture of 1 mL of triamcino- lone (40 mg), 4 mL of 2% lidocaine, and 5 mL of normal saline, as described for the IAI group, was injected slowly and with consistent pressure under sonographic guidance.
HD group For HD, an anterior approach was used with a 50-mL syringe and 21-gauge needle, and the procedure was performed with the patient in the supine position under overhead fluorosco- py in the operating room. Under fluoroscopy, the GH joint was identified and marked on the skin with a pen. After po- vidone sterilization, draping, and skin anesthesia, the needle
was placed immediately medial to the head of the humerus and approximately 1 cm lateral to the coracoid process, and it was directed posteriorly, slightly superiorly, and laterally, as described for the IAI group. The needle position was veri- fied by fluoroscopy. After aspiration and the injection of 4 mL of contrast medium for joint space confirmation, a mixture of 1 mL of triamcinolone (40 mg), 4 mL of local anesthetic (2% lidocaine), and 40 mL of normal saline was injected into the GH joint slowly and with pressure. When resistance was encountered, the injection was stopped momentarily and then continued. During the injection, the joint was gradually dis- tended, making the axillary and subscapular recesses more visible. The injection was continued until rupture of the capsule occurred. The capsule primarily ruptured in the wall of the subscapular recess or sometimes in the wall of the bicipital or axillary recess.29 The capsular rupture appeared as a loss of resistance, with leakage of contrast material on fluoroscopy.
All patients in the 3 groups received the same nonsteroi- dal anti-inflammatory drug for pain relief after injection. A stretching exercise program, as described previously, was started from the first day after injection.
Outcome evaluation
Clinical symptoms were evaluated at 4 time points for all pa- tients: before treatment and 1 month, 3 months, and 6 months after treatment. We set 6 months as the final follow-up eval- uation period because this period should be adequate to assess the result of the injection treatments and to decide on a sub- sequent treatment plan for a frozen shoulder. The clinical outcome was evaluated using the VAS score for pain (range, 0-10, with 10 indicating the worst pain), Simple Shoulder Test (SST), Constant score, and passive shoulder ROM.
Passive shoulder ROM was measured using a goniom- eter by a clinical researcher (A.-S.C.) who was blinded to the study. Forward elevation was measured in degrees between the arm and thorax in the scapular plane. External rotation at the side was measured in degrees between the thorax and forearm, with the arm held in an adducted position at 90° of elbow flexion. Internal rotation at the back was measured by the vertebral level reached with the tip of the thumb and num- bered serially 1 to 12 for the first to twelfth thoracic vertebrae, 13 to 17 for the first to fifth lumbar vertebrae, and 18 for any level below the sacral region.22
Statistical analysis
Statistical analysis was performed using SPSS 22.0 soft- ware (IBM, Armonk, NY, USA). Repeated-measures 1-way analysis of variance and post hoc Scheffé multiple compar- ison tests were used to identify significant differences in continuous variables among the groups; the χ 2 or Fisher exact test was used to identify any significant differences in cate- gorical variables. Before the analysis of variance test, the Kolmogorov-Smirnov test for normality and Levene test for
Table II Clinical scores by injection method
Variable VAS score for pain Simple Shoulder Test Constant score
IAI SAI HD IAI SAI HD IAI SAI HD
Preinjection 5.6 (2.1) 5.4 (2.6) 5.8 (1.5) 3.2 (1.8) 3.2 (2.9) 3.2 (2.2) 58.6 (17.1) 54.8 (17.1) 57.4 (20.0) 1 month 4.6 (1.1)* 4.2 (1.7) 3.6 (1.3)* 6.0 (2.5)* 6.1 (2.6)† 7.8 (2.0)*† 67.4 (19.8)* 64.2 (23.3) 78.1 (16.8)* 3 months 4.4 (1.5) 4.2 (1.8) 3.4 (1.4) 6.8 (1.6)* 6.0 (3.4)† 8.7 (3.4)*† 73.7 (18.1)* 64.8 (16.4) 77.3 (18.1)* 6 months 1.9 (1.1) 2.8 (1.6) 2.1 (1.3) 9.1 (1.2) 8.3 (2.8) 8.9 (1.2) 80.1 (14.2) 77.1 (17.6) 85.1 (11.2)
IAI, intra-articular injection; SAI, subacromial injection; HD, hydrodilatation. Values in parentheses are standard deviations. * Statistically significant difference (P < .05) between the HD group and IAI group. † Statistically significant difference (P < .05) between the HD group and SAI group.
The HD group showed a significantly lower VAS score for pain than the IAI group (P = .035) only at 1 month, a higher Simple Shoulder Test score than both the IAI group (P = .02 at 1 month and P = .05 at 3 months) and SAI group (P = .04 at 1 month and P = .004 at 3 months), and a higher Constant score than the IAI group (P = .039 at 1 month and P = .032 at 3 months). No differences between groups were found at 6 months.
380 J.P. Yoon et al.
homogeneity of variances were performed, and the assump- tion of normality and homogeneity of variances was fulfilled, all with P values > .05. The primary end point was the VAS score for pain, and the secondary end points were clinical scores and shoulder ROM. Values of P < .05 were consid- ered statistically significant.
Results
At the initial presentation, no intergroup differences were observed in the VAS score, SST, Constant score, and any ROM measure among the 3 groups. Each group displayed significant improvements from baseline to 6 months of follow-up (all P < .001). Every patient in each group was satisfied with his or her results at 6 months, and no patients required an additional treatment, such as manipulation or capsular release.
The VAS score for pain after 1 month of follow-up was significantly improved in the HD group compared with the IAI group (P = .035). However, at 3 and 6 months of follow- up, there were no statistically significant differences among the groups in the VAS score for pain (Table II).
For functional scores, at 1 month, the HD group exhib- ited a significant improvement in the SST compared with the IAI and SAI groups (P = .02 and .04, respectively) and a sig- nificant improvement in the Constant score compared with the SAI group (P = .039). At 3 months, the HD group had a significantly improved SST compared with the IAI and SAI groups (P = .05 and .004, respectively) and a significantly im- proved Constant score compared with the SAI group (P = .032). However, at 6 months, there were no significant differences in the SST or Constant score among the groups (all P > .05).
For ROM, at 1 month, the HD group experienced greater improvement in forward flexion (P = .009 and .007, respec- tively) and external rotation (P = .005 and .005, respectively) than the IAI and SAI groups (Table III). However, at 3 and 6 months, there were no significant differences among the groups in any ROM measure.
No patients exhibited steroid injection–related major com- plications, such as joint infection, permanent neurogenic symptoms, or steroid-induced arthritis. Several mild adverse effects were reported. Two patients in the IAI group and 1 patient in the SAI group complained of temporary mild diz- ziness and nausea after the injection. One patient in the HD group reported transient loss of sensation and motor control in the injected arm for a few hours after the injection, but these symptoms recovered without sequelae. One other patient in the HD group reported transient hypotensive syncope imme- diately after the injection, but the patient fully recovered after several minutes.
Discussion
The aim of this prospective randomized comparative trial was to evaluate whether 1 of the 3 injection methods for primary frozen shoulder was superior to the others. Steroid injection for the treatment of frozen shoulder has been widely used as a safe and effective treatment modality for pain relief.26,33 It may be used when medication or physical therapy exercise fails to relieve the symptoms of frozen shoulder before con- sideration of more traumatic or invasive treatments, such as manipulation under anesthesia or surgical capsular release.15
Three injection methods,…
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