Representative survey of frozen shoulder questionnaire responses from the Japan Shoulder Society: What are the appropriate diagnostic terms for primary idiopathic frozen shoulder, stiff shoulder or frozen shoulder?

Representative survey of frozen shoulder questionnaire responses from the Japan Shoulder Society: What are the appropriate diagnostic terms for primary idiopathic frozen shoulder, stiff shoulder or frozen shoulder?

Journal of Orthopaedic Science xxx (xxxx) xxx Contents lists available at ScienceDirect Journal of Orthopaedic Science journal homepage: http://www...

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Journal of Orthopaedic Science xxx (xxxx) xxx

Contents lists available at ScienceDirect

Journal of Orthopaedic Science journal homepage: http://www.elsevier.com/locate/jos

Original Article

Representative survey of frozen shoulder questionnaire responses from the Japan Shoulder Society: What are the appropriate diagnostic terms for primary idiopathic frozen shoulder, stiff shoulder or frozen shoulder?* Tsutomu Kobayashi a, Hiroshi Karasuno b, Hirotaka Sano a, Junichiro Hamada a, *, Katsumi Takase a, Kazuya Tamai c, Kenji Kashiwagi a, Kenji Hayashida a, Masafumi Gotoh a, Nobuyuki Yamamoto a, Toru Morihara a, Yukihiko Hata a, Yutaka Morisawa a a

Scientific Research Project Committee of Japan Shoulder Society, Tokyo, Japan Department of Physical Therapy, Josai International University, Chiba, Japan c Former President of Japan Shoulder Society, Tokyo, Japan b

a r t i c l e i n f o

a b s t r a c t

Article history: Received 5 September 2018 Received in revised form 10 December 2018 Accepted 10 December 2018 Available online xxx

Background: Primary frozen shoulder has unknown etiology and significant restriction of active and passive motion. The distinction between frozen shoulder and stiff shoulder has been unclear. Therefore, the purposes of this study were to perform a survey regarding definition and classification of frozen shoulder proposed by the American Academy of Orthopedic Surgeons (AAOS) among the members of the Japan Shoulder Society (JSS) and to compare the results with those obtained among the members of the American Shoulder and Elbow Surgeons (ASES). Methods: The Scientific Research Project Committee of the JSS prepared the questionnaire for frozen shoulder and stiff shoulder. Surveys were sent by e-mail on Jan 14, 2016 to JSS registered members and the response dead-line was set on March 13, 2016. Results: The number of respondents was 230, including all directors, councilors, and senior doctors. Agreement with the definition of primary frozen shoulder was 67%, the classification of primary or secondary frozen shoulder was 53%, and the 3 divisions of secondary frozen shoulder was 53%. Diagnostic terms for the cases of shoulder stiffness with unknown etiology were as follows: frozen shoulder (31%), stiff shoulder (22%), periarthritis scapulohumeralis (16%), so called “Gojukata” in Japan, which means shoulder problems in their fifties (16%), idiopathic frozen shoulder (6%), primary frozen shoulder (4%), adhesive capsulitis (3%), others (2%). Conclusion: The survey shows lower rates of agreement among the JSS members than the ASES members for the definition of primary frozen shoulder, the classification of primary and secondary frozen shoulder, and the divisions of secondary frozen shoulder. To avoid confusion between stiff shoulder and frozen shoulder, the committee agrees to the ISAKOS recommendation that the term “frozen shoulder” should be used exclusively for primary idiopathic stiff shoulder. © 2019 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.

1. Introduction Frozen shoulder is a common shoulder disorder affecting middle aged individuals; however, its etiology, diagnostic criteria, and

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The survey of the questionnaire was approved by the Japan Shoulder Society. * Corresponding author. Department of Orthopedic Surgery, Kuwano Kyoritsu Hospital, 2-9-18 Shima, Koriyama, Fukushima, 963-8034, Japan. Fax: þ81 24 923 6163. E-mail address: [email protected] (J. Hamada).

management are controversial. The varied terms expressing primary frozen shoulder (i.e., adhesive capsulitis, idiopathic frozen shoulder, and periarthritis scapulohumeralis), unknown etiology, absence of a specific definition, and undefined significant restriction of motion, make a comparison of the results between studies difficult. Frozen shoulder was named by Codman [1] in 1934, who described it in his book as, “difficult to define, difficult to treat and difficult to explain from the point of view of pathology. The typical case is one of frozen shoulder, which shows no calcified deposit, and in which a history of trauma is absent, vague or not clearly

https://doi.org/10.1016/j.jos.2018.12.012 0949-2658/© 2019 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.

Please cite this article as: Kobayashi T et al., Representative survey of frozen shoulder questionnaire responses from the Japan Shoulder Society: What are the appropriate diagnostic terms for primary idiopathic frozen shoulder, stiff shoulder or frozen shoulder?, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2018.12.012

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T. Kobayashi et al. / Journal of Orthopaedic Science xxx (xxxx) xxx

associated with the onset of symptoms.” Thus, the definition, etiology, and management of frozen shoulder as initially documented by Codman is enigmatic. The American Academy of Orthopaedic Surgeons (AAOS) defined frozen shoulder as a condition of uncertain etiology characterized by significant restriction of both active and passive shoulder motion that occurs in the absence of a known intrinsic shoulder disorder. In addition, frozen shoulder was classified into primary (idiopathic) and secondary divisions; the former is not identified with any etiology, and the latter associates with known disorders or trauma [2] (Fig. 1). A survey of 190 members of the American Shoulder and Elbow Surgeons (ASES) reported that 82% of the responders agreed with the proposed definition of primary frozen shoulder, and that 85% of the responders agreed that frozen shoulder was divided into primary and secondary types [3]. The Upper Extremity Committee of the International Society of Arthroscopy, Knee Surgery and Orthopaedic Sport Medicine (ISAKOS) proposed in 2015 that frozen shoulder should be used exclusively to describe the primary idiopathic stiff shoulder, and that secondary stiff shoulder should be used to describe all other cases of shoulder stiffness with a known etiology [4] (Fig. 1). Through the process of fluctuating definition and terminology, controversies have arisen and resulted in discussions of whether the term of frozen shoulder should only apply to primary idiopathic stiff shoulder, and if a classification of primary and secondary frozen shoulder would be scientifically reliable among members of the Japan Shoulder Society (JSS) [5,6]. The distinction between the terms stiff shoulder and frozen shoulder has become ambiguous. Therefore, the Scientific Research Project Committee of the JSS which was a neutral observer from the definition of the AAOS and ISAKOS issued a questionnaire to survey perceptions of the definition and classification for frozen shoulder proposed by the AAOS, the difference between stiff shoulder and frozen shoulder, and which terms JSS members choose for patients with primary frozen shoulder. The first purpose of the present study was to compare the rates of agreement between the ASES and JSS for the definition of primary frozen shoulder, the classification of primary and secondary frozen shoulder, and the division of secondary frozen shoulder into intrinsic, extrinsic, and systemic factors as proposed by the AAOS. The second purpose was to propose an appropriate diagnostic term for primary idiopathic frozen shoulder for the JSS.

2. Materials and methods 2.1. Preparation, survey, and analysis of the questionnaire The Scientific Research Project Committee of the JSS prepared the questionnaire as shown in Appendix 1. The definition, classification, and divisions of frozen shoulder were based on those of the AAOS in 1993 [2]. Surveys were sent by e-mail on January 14, 2016 and the response dead-line was set on March 13, 2016. Two hundred thirty members, including all directors, councilors, senior doctors, and younger doctors who wanted to participate, responded to the questionnaire. Based on answers to question 1 regarding stiff and frozen shoulder, the correlations between these answers and the answers to questions 2e5 were determined. Finally, we investigated which diagnostic terms JSS members chose in cases of shoulder contracture with unknown etiology.

2.2. Appendix 1 questionnaire for frozen and stiff shoulder Question 1: Are the two terms of stiff shoulder and frozen shoulder the same meaning?  the same,  not the same,  stiff shoulder includes frozen shoulder,  other opinion Question 2: Do you agree with the definition of primary (idiopathic) frozen shoulder as defined by the American Academy of Orthopaedic Surgeons (AAOS) in 1993?  agree,  do not agree,  other opinion Question 3: Do you agree that frozen shoulder can be classified into primary and secondary types as defined by AAOS?  agree,  do not agree,  other opinion Question 4: Do you consider that there is a true primary (idiopathic) frozen shoulder?  present,  absent,  other opinion Question 5: Is the division of secondary types into intrinsic, extrinsic, and systemic appropriate?  appropriate,  not appropriate,  other opinion Question 6: Which term do you use in cases of shoulder contracture with unknown etiology? (Multiple choices are available.)

Fig. 1. Definition and classification proposed by AAOS and ISAKOS. AAOS, the American Academy of Orthopaedic Surgeons; ISAKOS, the International Society of Arthroscopy, Knee Surgery and Orthopaedic Sport Medicine.

Please cite this article as: Kobayashi T et al., Representative survey of frozen shoulder questionnaire responses from the Japan Shoulder Society: What are the appropriate diagnostic terms for primary idiopathic frozen shoulder, stiff shoulder or frozen shoulder?, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2018.12.012

T. Kobayashi et al. / Journal of Orthopaedic Science xxx (xxxx) xxx

 frozen shoulder,  stiff shoulder,  periarthritis scapulohumeralis,  adhesive capsulitis,  primary frozen shoulder,  idiopathic frozen shoulder,  so-called “Gojukata” in Japan, which means shoulder problems in their fifties,  other term

2.3. Statistical analysis A chi-square test for population variance was used in agedistribution for all questions, and in statistical analyses of 214 respondents who answered the same, not the same, or stiff shoulder includes frozen shoulder to question 1. The same test was also conducted to investigate whether answers to question 1 correlated with those to questions 2, 3, 4, and 5. Multiple comparisons Bonferroni post-hoc tests were performed when there was significant difference detected by the chi-square test. All statistical analyses were performed using EZR on R commander for Mac OSX ver. 1e32 and statistical significance was defined as p < .05 [7]. 3. Results 3.1. Age distribution and responses The number of respondents was 230 representative members, including all directors, councilors and senior doctors, and the distribution of age among the respondents was 33 (14.3%) 20e39 years, 164 (71.4%) 40e59 years, and 33 (14.3%) 60e70 years. The results of the questionnaire appear to best represent the opinion of respondents in the 40e59 years bracket. Hence, we statistically analyzed if age distribution was related to choices for all questions. There were no significant differences in age distribution for answers to question 1 (p ¼ .455), question 2 (p ¼ .749), question 3 (p ¼ .733), question 4 (p ¼ .097), and question 5 (p ¼ .598). Therefore, age, according to groups of 20e39 years, 40e59, and 60e70 years, did not influence the answers. 3.2. Summary of answers to all questions The results in each item are summarized in Table 1. One hundred twenty-four respondents (54%) agreed that stiff shoulder included frozen shoulder, 56 (24%) agreed they were not the same, and 34 (15%) agreed that they were the same in question 1. One hundred fifty-four respondents (67%) agreed with the definition of primary frozen shoulder as proposed by the AAOS in question 2. The proposed classification for primary or secondary frozen shoulder was

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agreed to by 121 of respondents (53%) in question 3. One hundred fifty-nine respondents (69%) agreed that there truly was a primary frozen shoulder in question 4. Division of secondary types into intrinsic, extrinsic, and systemic was agreed to by 122 respondents (53%) in question 5. Diagnostic terms to the cases of shoulder contracture with unknown etiology were as follows: frozen shoulder (31%), stiff shoulder (22%), periarthritis scapulohumeralis (16%), “Gojukata” in Japan, which means shoulder problems in their fifties (16%), idiopathic frozen shoulder (6%), primary frozen shoulder (4%), adhesive capsulitis (3%), and others (2%) in question 6. 3.3. Correlation between interpretations of stiff and frozen shoulder and the definitions of frozen shoulder proposed by the AAOS Two hundred fourteen of the respondents (93%), who answered that stiff shoulder was the same as frozen shoulder, not the same, or stiff shoulder included frozen shoulder to question 1, were included in a comparison study to investigate the correlation with the answers to questions 2, 3, 4, and 5 (Fig. 2). The correlation between answers to question 1 and 2 did not show statistical significance (p ¼ .359). The considerations of stiff and frozen shoulder did not correspond to agreement with the definition of primary frozen shoulder. Answers to questions 1 and 3 were significantly correlated (p ¼ .048) (Fig. 2). Consideration concerning stiff shoulder and frozen shoulder related to rate of agreement with classification of primary and secondary frozen shoulder. Seventy-three percent of responders who considered that stiff shoulder is the same as frozen shoulder in question 1 agreed with the classification of primary and secondary frozen shoulder. Conversely, 48% of those who answered that they were not the same agreed with the classification. Comparison between answers to questions 2 and 3 showed a statistically significant correlation (p ¼ .015) (Fig. 2). Sixty-nine percent of respondents who agreed with the definition of primary frozen shoulder agreed with the classification of primary or secondary frozen shoulder. The percentage (45%) of agreement for classification of primary and secondary frozen shoulder was at a lower rate among those who disagreed with the definition of primary frozen shoulder. In addition, 91% of the respondents who agreed with the classification of primary and secondary frozen shoulder strongly agreed with the division of secondary types into intrinsic, extrinsic, and systemic (p ¼ .0001) in question 3 and 5 (Fig. 2). The respondents disagreeing with the classification into two types of frozen shoulder tended to disagree with the division of secondary types into intrinsic, extrinsic, and systemic (79%) (p ¼ .0001).

Table 1 Summary of responses to the questionnaire. Question number

Content of question

Items

Question 1

Stiff shoulder and frozen shoulder are same? Definition of primary frozen shoulder Classification of primary and secondary frozen shoulder Presence of primary frozen shoulder Division of secondary frozen shoulder into intrinsic, extrinsic, systematic Which term do you use in cases of stiff shoulder with unknown etiology?

Same 15% Agree 67% Agree 53% Present 69% Appropriate

Question 2 Question 3 Question 4 Question 5

Question 6

53% Frozen shoulder 31%

Not same 24% Not agree 20% Not agree 31% Absent 14% Not appropriate 28% Stiff shoulder 22%

SS include FS 54% Other opinion 13% Other opinion 16% Other opinion 17% Other opinion

Other opinion 7% Total 230 (100%) Total 230 (100%) Total 230 (100%) Total

Total 230 (100%)

19% PS

230 (100%) Gojugata

Idiopathic FS

Primary FS

AC

Others

Total

16%

16%

6%

4%

3%

2%

230 (100%)

SS, stiff shoulder; FS, frozen shoulder; PS, periarthritis scapulohumeralis; AC, adhesive capsulitis.

Please cite this article as: Kobayashi T et al., Representative survey of frozen shoulder questionnaire responses from the Japan Shoulder Society: What are the appropriate diagnostic terms for primary idiopathic frozen shoulder, stiff shoulder or frozen shoulder?, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2018.12.012

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T. Kobayashi et al. / Journal of Orthopaedic Science xxx (xxxx) xxx

Fig. 2. Correlations of responses to question 1 to those of question 2e5. The respondents who answered that stiff shoulder was the same as frozen shoulder, not the same, and stiff shoulder, included frozen shoulder to question 1. Q1, question 1; PFS, primary frozen shoulder; SFS, secondary frozen shoulder; C, chi-square test.

4. Discussion The most important finding of the present survey is the lower rate of agreement with the definition of primary frozen shoulder (67%), the classification of primary and secondary frozen shoulder (53%), and the divisions of secondary frozen shoulder (53%) proposed by the AAOS between the JSS and the ASES (82%, 85%, and 66%, respectively) [3]. One reason for the discrepancy appears to be the difference in the percentage of respondents who agreed with the presence of primary frozen shoulder between the ASES (84%) and the JSS (69%). Fewer shoulder surgeons in the JSS agreed that primary frozen shoulder is present; therefore, the rate of agreement with the definition of primary frozen shoulder by the AAOS becomes lower. The members, who do not consider that primary frozen shoulder is present, believe that there is the presence of an unconscious prior minor trauma or intrinsic lesions, such as degenerative change or partial tears of the rotator cuff. The rates of agreement with the classification of primary and secondary frozen shoulder and the divisions of secondary frozen shoulder proposed by the AAOS are lower in the JSS than those in the ASES. Most members, who do not agree with the classification and divisions of secondary frozen shoulder, describe that secondary frozen shoulder is not an appropriate term, but stiff shoulder is acceptable. In other words, their consideration is that frozen shoulder should be used only with primary frozen shoulder and that it is better to change secondary frozen shoulder to secondary stiff shoulder. This statement is the same as the proposal by the

ISAKOS, which is that secondary stiff shoulder should be used to describe all other cases of shoulder stiffness with a known etiology [4]. Consideration of stiff shoulder and frozen shoulder does not affect agreement with the definition of primary frozen shoulder in our survey. However, the new consensus proposed by ISAKOS may reduce the rate of agreement with the definition and the classification of primary and secondary frozen shoulder. One hundred one studies for primary frozen shoulder were published between January 2017 and May, 2018. The frequency of diagnostic terms in the titles of the papers is adhesive capsulitis 46 (45%) [8], frozen shoulder 42 (41%) [9], idiopathic adhesive capsulitis 6 (6%) [10], primary frozen shoulder 4 (4%) [11], idiopathic frozen shoulder 3 (3%) [12] (Fig. 3). Periarthritis scapulohumeralis has not been used as a title term since 2014. Adhesive capsulitis and frozen shoulder are the most common diagnostic terms among shoulder surgeon in other countries. JSS members tend to use stiff shoulder, periarthritis scapulohumeralis, and so called “Gojukata” in Japan, which means shoulder problems in their fifties frequently, but do not like to use adhesive capsulitis. Three reasons may be referred to why we use frozen shoulder, stiff shoulder, periarthritis scapulohumeralis, and so-called “Gojukata”. The first reason is that frozen shoulder, adhesive capsulitis, periarthritis scapulohumeralis, and so-called “Gojukata” have been described as the diagnostic terms in the Glossary of Orthopedic Surgery, as edited by the Japan Orthopedic Association. Therefore, frozen shoulder, periarthritis scapulohumeralis, and so called “Gojukata” are the common four diagnostic terms for Japanese shoulder surgeons.

Fig. 3. Comparison of diagnosis terms for primary idiopathic frozen shoulder between the questionnaire of the Japan Shoulder Society and titles of the published papers. PFS, primary frozen shoulder; IFS, idiopathic frozen shoulder; AC, adhesive capsulitis; IAC, idiopathic adhesive capsulitis.

Please cite this article as: Kobayashi T et al., Representative survey of frozen shoulder questionnaire responses from the Japan Shoulder Society: What are the appropriate diagnostic terms for primary idiopathic frozen shoulder, stiff shoulder or frozen shoulder?, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2018.12.012

T. Kobayashi et al. / Journal of Orthopaedic Science xxx (xxxx) xxx

The committee of the JSS agrees to the ISAKOS recommendation that the term “frozen shoulder” should be used exclusively for primary idiopathic stiff shoulder through this survey [4,5]. The term of stiff shoulder should be used to describe the patient with a restricted range of motion. The ISAKOS recommendation indicates a clear distinction between stiff shoulder and frozen shoulder. More than 50% of responders consider that stiff shoulder includes frozen shoulder, using frozen shoulder and stiff shoulder as diagnostic terms for primary frozen shoulder. The committee of the JSS agrees that the term of frozen shoulder have to be used to describe the primary idiopathic stiff shoulder through the survey. Another recommendation of the ISAKOS is that adhesive capsulitis is not recommended, as it does not reflect the pathological processes present [4,5]. Periarthritis scapulohumeralis is also not appropriate, because inflammation is present only in the glenohumeral joint and apparently absent around the scapula, as shown by MRI [6,13]. So called “Gojukata”is an original Japanese diagnostic term, but it is an old slang term. Thus, we would be better to exclude the terms of adhesive capsulitis, periarthritis scapulohumeralis, and so called “Gojukata”. There are some limitations in this study. The first limitation is that contents of the questionnaire may influence the results in the survey. For example, the answer to Question 3 “Do you agree that frozen shoulder can be classified into primary and secondary types?” could have been different if the following question had been included in this questionnaire, “Do you agree that stiff shoulder can be classified into primary and secondary types?” The second limitation is that the survey is preliminary and representative. Respondents to the questionnaire consisted of 16% of JSS members; therefore, the answers may not completely represent the view of the entire JSS. The final limitation is that the survey is not sufficient to simplify opinions of frozen shoulder due to the presence of the various different understandings of the term. Steps toward consensus for a frozen shoulder definition and identification of the differences between stiff shoulder and frozen shoulder are important. 5. Conclusion The survey shows lower rates of agreement among the JSS members that the ASES members for the definition of primary frozen shoulder, the classification of primary and secondary frozen

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shoulder, and the divisions of secondary frozen shoulder. To avoid confusion between stiff shoulder and frozen shoulder, the committee agrees to the ISAKOS recommendation that the term “frozen shoulder” should be used exclusively for primary idiopathic stiff shoulder. Conflict of interest There is no conflict of interest. References [1] Codman EA. Arthritis, periarthritis, and bursitis of the shoulder joint. In: The shoulder. Boston: Thomas Todd Co; 1934. p. 216e24. [2] Zuckerman JD, Cuomo F. Froze shoulder. In: Masten ⅢFA, Fu FH, Hawkins RJ, editors. The shoulder: a balance of mobility and stability. Chicago: American Academy of Orthopedic Surgery; 1993. p. 253e67. ISBN: 9780892030910. [3] Zuckerman JD, Rokito A. Frozen shoulder: a consensus definition. J Shoulder Elbow Surg 2011 Mar;20(2):322e5. [4] Bain GI, Clitherow HDS. The pathogenesis and classification of shoulder stiffness. In: Itoi E, Arce G, editors. Shoulder stiffness. New York: Springer; 2015. P3e19. ISBN: 9783662463697. [5] Itoi E, Arce G, Bain GI, Diercks RL, Guttmann D, Imhoff AB, Mazzocca AD, Sugaya H, Yoo YS. Shoulder stiffness: current concepts and concerns. Arthroscopy 2016 Jul;32(7):1402e14. [6] Tamai K, Akutsu M, Yano Y. Primary frozen shoulder: brief review of pathology and imaging abnormalities. J Orthop Sci 2014 Jan;19(1):1e5. [7] Kanda Y. Investigation of the freely available easy-to use software ‘EZR’ for medical statistics. Bone Marrow Transplant 2013 Mar;48(3):452e8. [8] Gyftopoulos S, Abballe V, Virk MS, Koo J, Gold HT, Subhas N. Comparison between image-guided and landmark-based glenohumeral joint injections for the treatment of adhesive capsulitis: a Cost-Effectiveness Study. AJR Am J Roentgenol 2018 Jun;210(6):1279e87. [9] Hagiwara Y, Ando A, Kanazawa K, Koide M, Sekiguchi T, Hamada J, Itoi E. Arthroscopic coracohumeral ligament release for patients with frozen shoulder. Arthrosc Technol 2017 Dec;7(1):e1e5. [10] Cvetanovich GL, Leroux TS, Bernardoni ED, Hamamoto JT, Saltzman BM, Verma NN, Romeo AA. Clinical outcomes of arthroscopic 360 capsular release for idiopathic adhesive capsulitis in the lateral decubitus position. Arthroscopy 2018 Mar;34(3):764e70. [11] Robinson PM, Norris J, Roberts CP. Randomized controlled trial of supervised physiotherapy versus a home exercise program after hydrodilatation for the management of primary frozen shoulder. J Shoulder Elbow Surg 2017 May;26(5):757e65. [12] Ando A, Hamada J, Hagiwara Y, Sekiguchi T, Koide M, Itoi E. Short-term clinical Results of manipulation under ultrasound-guided brachial plexus block in patients with idiopathic frozen shoulder and diabetic secondary frozen shoulder. Open Orthop J 2018 Mar 16;12:99e104. [13] Sasanuma H, Sugimoto H, Fujita A, Kanaya Y, Iijima Y, Saito T, Takeshita K. Characteristics of dynamic magnetic resonance imaging of idiopathic severe frozen shoulder. J Shoulder Elbow Surg 2017 Feb;26(2):e52e7.

Please cite this article as: Kobayashi T et al., Representative survey of frozen shoulder questionnaire responses from the Japan Shoulder Society: What are the appropriate diagnostic terms for primary idiopathic frozen shoulder, stiff shoulder or frozen shoulder?, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2018.12.012