Efficacy of Combination Therapy (Hydrodilatation and Subdeltoid Bursa Injection With Corticosteroid, Mobilization, and Physical Therapy) vs Physical Therapy Alone for Treating Frozen Shoulder: A Randomized Single-Blind 聯合治療（水擴張和三角肌下滑囊注射與皮質類固醇、動員和物理治療）與單獨物理治療治療肩周炎的療效：隨機單盲
Controlled Trial, Phase I 對照試驗，I 期
Yu-Hao Huang, PT, ^(a){ }^{a} Ying-Chen Kuo, MD, ^(a,b){ }^{a, b} Lin-Fen Hsieh, MD, ^(a,b){ }^{a, b} Chun-Mei Tsai, PT, ^(a){ }^{a} Ya-Fang Liu, PhD, ^("c "){ }^{\text {c }} Tien-Lee Hsieh, MD ^("a "){ }^{\text {a }} Yu-Hao Huang， PT， ^(a){ }^{a} Ying-Chen Kuo， MD， ^(a,b){ }^{a, b} Lin-Fen Hsieh， MD， ^(a,b){ }^{a, b} Chun-Mei Tsai， PT， ^(a){ }^{a} Ya-Fang Liu， PhD， ^("c "){ }^{\text {c }} Tien-Lee Hsieh， MD ^("a "){ }^{\text {a }}From the ^("a "){ }^{\text {a }} Department of Physical Medicine and Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan; ^("b "){ }^{\text {b }} School of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan; and 'Administration Division, Research Department, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan. 臺灣臺北新光吳浩洙紀念醫院物理醫學與康復 ^("a "){ }^{\text {a }} 科;輔仁大學醫學 ^("b "){ }^{\text {b }} 院，臺灣新北市;和「臺灣臺北新光吳浩洙紀念醫院研究部行政部」。。
Abstract 抽象
Objective: To compare the efficacy of combination therapy (hydrodilatation and subdeltoid bursa injection with corticosteroid, mobilization, and physical therapy [PT][\mathrm{PT}] ) with that of PT alone for treating frozen shoulder. Design: A prospective, 2-arm parallel, single-blinded, randomized controlled trial. Setting: Rehabilitation clinic of a private academic hospital. " Participants: Patients ( n=70\mathrm{n}=70 ) with frozen shoulder (freezing stage). Interventions: Participants ( n=35\mathrm{n}=35 ) in the combination group underwent hydrodilatation and subdeltoid bursa injection with corticosteroid twice, mobilization, and usual-care PT for 8 weeks; participants ( n=35\mathrm{n}=35 ) in the PT group received only the usual-care PT for 8 weeks. Main Outcome Measures: The Shoulder Pain and Disability Index (SPADI) was the primary outcome measure. The secondary outcome measures were pain scores on a visual analog scale, range of motion (ROM), the Shoulder Disability Questionnaire (SDQ), quality of life (evaluated using the 36-item Short-Form Health Survey [SF-36]), and self-assessment of the treatment effect. Results: Compared with the PT group, the combination group had significantly better pain (during activity), SPADI, SDQ, active and passive ROM, and self-assessment scores (all P < .001P<.001 ) as well as scores on some parts of the SF-36 (physical function and bodily pain, P < .05P<.05 ). Betweengroup differences were significant at the 1-, 2-, 4-, and 6-month follow-ups. Conclusions: A combination of hydrodilatation (with corticosteroid), bursal corticosteroid injection, and joint mobilization with PT was superior to PT alone for treating frozen shoulder, and the effects persisted for at least 6 months. Archives of Physical Medicine and Rehabilitation 2024;105:631-8 目的：比較聯合治療（水擴張和三角肌下滑囊注射聯合皮質類固醇、動員和物理治療 [PT][\mathrm{PT}] ）與單獨 PT 治療肩周炎的療效。設計：一項前瞻性、2 臂平行、單盲、隨機對照試驗。地點：私立學術醫院的康復診所。“ 參與者：肩周炎（冰凍期）患者 （ n=70\mathrm{n}=70 ）。干預措施：聯合組參與者（ n=35\mathrm{n}=35 ）接受水擴張和三角肌下滑囊注射皮質類固醇兩次、活動和常規護理 PT 8 周;PT 組的參與者 （ n=35\mathrm{n}=35 ） 僅接受常規護理 PT 8 周。主要結果指標：肩痛和殘疾指數 （SPADI） 是主要結果指標。次要結果指標是視覺類比量表上的疼痛評分、運動範圍 （ROM）、肩部殘疾問卷 （SDQ）、生活品質（使用 36 項簡短健康調查 [SF-36] 進行評估）和治療效果的自我評估。結果：與 PT 組相比，聯合組的疼痛（活動期間）、SPADI、SDQ、主動和被動 ROM、自我評估評分（全部 P < .001P<.001 ）以及 SF-36 某些部位的評分（身體機能和身體疼痛） P < .05P<.05 明顯更好。在 1、2、4 和 6 個月的隨訪中，組間差異顯著。結論：水擴張（聯合皮質類固醇）、法氏囊皮質類固醇注射、關節動員聯合 PT 治療肩周福優於單用 PT，且效果持續至少 6 個月。2024 年物理醫學與康復檔案;105:631-8
Frozen shoulder, or adhesive capsulitis of the shoulder, is characterized by repeated inflammation and fibrosis of the joint capsule, resulting in pain and loss of both passive and active range of 肩周炎，或肩關節粘連性關節囊炎，其特徵是關節囊反覆發炎和纖維化，導致疼痛和被動和主動範圍喪失
motion (ROM), thereby affecting shoulder function and quality of life. ^(1){ }^{1} Frozen shoulder can be primary (idiopathic) or secondary (related to medical conditions, such as an injury; inflammatory, immunologic, and endocrine disorders; or surgery). ^(1){ }^{1} Its prevalence in the general population is 2%-5%2 \%-5 \%, but women and middleaged adults are most commonly affected. ^(2,3){ }^{2,3} Primary frozen shoulder is a self-limiting disease that often improves on its own within 運動（ROM），從而影響肩部功能和生活品質。 ^(1){ }^{1} 肩周炎可以是原發性（特發性）或繼發性（與軀體疾病有關，如損傷、炎症、免疫和內分泌失調或手術）。 ^(1){ }^{1} 它在普通人群中的患病率為 2%-5%2 \%-5 \% ，但女性和中年人最常受到影響。 ^(2,3){ }^{2,3} 原發性肩周炎是一種自限性疾病，通常會自行改善
18-24 months, with some residual ROM limitation. ^(1){ }^{1} Most investigators define “frozen shoulder” as a global restriction of both active and passive ROM, particularly in external rotation. The radiograph of the affected shoulder usually appears normal. Clinically, a frozen shoulder is typically divided into 3 stages: the “freezing” stage characterized by pain and inflammation, the “frozen” stage marked by capsule fibrosis, and the “thawing” stage where there is minimal pain and a gradual return of function. ^(4){ }^{4} 18-24 個月，有一些殘留 ROM 限制。 ^(1){ }^{1} 大多數研究人員將「肩周炎」定義為主動和被動 ROM 的整體限制，特別是在外旋方面。受影響肩部的 X 光片通常看起來正常。臨床上，肩周炎通常分為 3 個階段：以疼痛和炎症為特徵的“凍結”階段、以包膜纖維化為特徵的“凍結”階段以及疼痛最小且功能逐漸恢復的“解凍”階段。 ^(4){ }^{4}
Treatment of frozen shoulder comprises physical therapy, oral medication (nonsteroidal anti-inflammatory drugs or corticosteroids), intra-articular corticosteroid injection, hydrodilatation, suprascapular nerve block, mobilization, manipulation under anesthesia, and, in refractory cases, surgery (arthroscopic release or open release). ^(5-8){ }^{5-8} Although manipulation under anesthesia yields a high success rate, complications such as glenohumeral joint fracture and dislocation, rotator cuff tear, and brachial plexus injury may occur. ^(9-11){ }^{9-11} 肩周炎的治療包括物理治療、口服藥物（非甾體抗炎藥或皮質類固醇）、關節內皮質類固醇注射、水擴張、肩胛上神經阻滯、動員、麻醉下作，以及難治性病例的手術（關節鏡松解或開放鬆解）。 ^(5-8){ }^{5-8} 雖然麻醉下推拿的成功率很高，但可能會出現盂肱關節骨折脫位、肩袖撕裂、臂叢神經損傷等併發症。 ^(9-11){ }^{9-11}
Physical therapy can relieve pain, improve ROM, and increase muscle strength. ^(10-13){ }^{10-13} Mobilization of the joint involves the use of an externally imposed small-amplitude passive motion to produce gliding or traction at a joint. ^(14){ }^{14} By restoring the accessory motion of a joint, mobilization can increase joint extensibility and ROM while also decreasing pain in patients with primary frozen shoulder. ^(14-16){ }^{14-16} Corticosteroid injection can provide rapid pain relief, inflammation reduction, and ROM improvement, thereby facilitating compliance with exercise therapy; however, the long-term outcomes of corticosteroid injection are similar to those of other treatments. ^(17){ }^{17} 物理治療可以緩解疼痛、改善 ROM 和增加肌肉力量。關節的 ^(10-13){ }^{10-13} 動員涉及使用外部施加的小振幅被動運動在關節處產生滑動或牽引力。 ^(14){ }^{14} 通過恢復關節的輔助運動，活動可以增加關節的伸展性和 ROM，同時還可以減輕原發性肩周炎患者的疼痛。 ^(14-16){ }^{14-16} 皮質類固醇注射可以快速緩解疼痛、減輕炎症和改善 ROM，從而促進運動治療的依從性;然而，皮質類固醇注射的長期結果與其他治療相似。 ^(17){ }^{17}
Hydrodilatation involves an intra-articular infusion of normal saline, which can increase joint volume and distend the joint capsule. However, a large volume may exert physical stress on the constricted joint capsule, resulting in inflammation of the joint capsule due to stretching injury. The addition of corticosteroid with normal saline has been reported to reduce inflammation in the glenohumeral joint. ^(18.19){ }^{18.19} Although a moderate amount of evidence supports the use of hydrodilatation in treating frozen shoulder, its long-term outcomes remain unclear. ^(19){ }^{19} Some reports have demonstrated that hydrodilatation without manipulation was less effective than the use of intensive mobilization alone, indicating that postintervention exercise or mobilization is crucial. ^(20){ }^{20} 水擴張涉及關節內輸注生理鹽水，這可以增加關節體積並擴張關節囊。然而，大體積可能會對收縮的關節囊施加物理壓力，導致拉伸損傷導致關節囊發炎。據報導，將皮質類固醇與生理鹽水一起加入可以減輕盂肱關節的炎症。 ^(18.19){ }^{18.19} 儘管有少量證據支援使用水擴張治療肩周炎，但其長期結果仍不清楚。 ^(19){ }^{19} 一些報告表明，不進行作的水擴張不如單獨使用強化動員有效，這表明干預后的鍛煉或動員至關重要。 ^(20){ }^{20}
For injection or hydrodilatation of the glenohumeral joint, the posterior approach under ultrasound guidance has been commonly used because of the easy visualization of the joint capsule for needle advancement and the avoidance of radiation exposue. ^(19){ }^{19} A predominant pathology for frozen shoulder is contracture of the anterior joint capsule and coracohumeral ligament at the rotator interval, resulting in marked limitation of external rotation of the shoulder. ^(21.22){ }^{21.22} Injection through the anterior approach may help release the contracture. Therefore, for treating frozen shoulder, hydrodilatation through both approaches may be equally important. ^(23){ }^{23} 對於盂肱關節的注射或水擴張，由於關節囊易於觀察針前進並避免輻射暴露，因此通常使用超聲引導下的後路入路。 ^(19){ }^{19} 肩周炎的主要病理是前關節囊和喙肱韌帶在旋轉肌間期攣縮，導致肩部外旋明顯受限。 ^(21.22){ }^{21.22} 通過前路注射可能有助於釋放攣縮。因此，對於治療肩周炎，通過兩種方法進行水擴張可能同樣重要。 ^(23){ }^{23}
A combination of various modalities is common for frozen shoulder and can improve the outcomes ^(13){ }^{13}; however, various 肩周炎常見多種方式的組合，可以改善結局 ^(13){ }^{13} ;然而，各種
List of abbreviations: 縮寫清單：
ROM range of motion ROM 運動範圍
SDQ the Shoulder Disability Questionnaire SDQ 肩部殘疾問卷
SF-36 the 36-item Short-Form Health Survey SF-36 包含 36 項的簡短健康調查
SPADI the Shoulder Pain and Disability Index SPADI 肩痛和殘疾指數
VAS visual analog scale VAS 視覺類比量表
combinations are possible, and the effectiveness of combination treatment remains unclear. As far as we know, there are still insufficient randomized controlled trials regarding combined treatments for frozen shoulder. Therefore, we proposed a comprehensive treatment package for this condition: double hydrodilatation, subdeltoid bursa injection with a corticosteroid, mobilization, and usual-care physical therapy. We hypothesized that the effect of this combination would be superior to that of usual-care physical therapy alone and facilitate faster recovery. 聯合治療是可能的，聯合治療的有效性仍不清楚。據我們所知，關於肩周炎聯合治療的隨機對照試驗仍然不足。因此，我們針對這種情況提出了一個全面的治療方案：雙重水擴張、三角肌下滑囊注射皮質類固醇、動員和常規護理物理治療。我們假設這種組合的效果將優於單獨的常規護理物理治療，並有助於更快的恢復。
Methods 方法
Study design 學習規劃
This single-blinded randomized controlled trial was approved by the Institutional Review Board of the author’s hospital. The study was conducted from August 1, 2020, to July 31, 2022. Patients in the freezing stage of frozen shoulder were recruited from the outpatient clinic of the Department of Physical Medicine and Rehabilitation of the author’s hospital. After signing the informed consent form, the patients were randomly divided into the combination group (receiving a combination of hydrodilatation, corticosteroid injection, joint mobilization, and the usual-care physical therapy) and the PT group (receiving only the usual-care physical therapy) on the basis of a random number generated by a statistician using a computer program. The numbers were sealed in opaque envelopes, which were opened after the patients were enrolled. The patients and the evaluator were blinded to patient allocation, but the physician and physical therapist performing joint injection or mobilization were not. 這項單盲隨機對照試驗得到了作者醫院機構審查委員會的批准。該研究於 2020 年 8 月 1 日至 2022 年 7 月 31 日進行。肩周炎冰凍期患者從筆者所在醫院物理醫學與康復科門診招募。簽署知情同意書後，根據統計學家使用計算機程式生成的隨機數，將患者隨機分為聯合組（接受水擴張、皮質類固醇注射、關節動員和常規物理治療的組合）和 PT 組（僅接受常規護理物理治療）。這些數位被密封在不透明的信封中，在患者入組后打開。患者和評估者對患者分配不知情，但進行關節注射或動員的醫生和物理治療師則不知情。
Participants 參與者
The following inclusion criteria were applied: (1) being aged 2080 years old, (2) having shoulder pain for >= 1\geq 1 month, (3) having a >= 30%\geq 30 \% limitation in passive ROM (either external rotation or abduction), and (4) having a pain visual analog scale (VAS) >= 4\geq 4 during passive terminal range of shoulder external rotation or abduction. We excluded patients with (1) severe systemic disease such as stroke, parkinsonism, thyroid diseases, cancer, cardiopulmonary diseases, rheumatic or connective tissue diseases (rheumatoid arthritis, scleroderma, Dupuytren’s contracture, etc), or uncontrolled diabetes mellitus; (2) calcification or rupture of the rotator cuff on the affected side; (3) shoulder fracture or dislocation; (4) previous shoulder or non-shoulder surgery (cardiac, cervical spine, or thoracic spine surgery) (5) history of allergy to local anesthetics or corticosteroids; or (6) corticosteroid or hyaluronic acid joint or bursa injection of the affected shoulder in the 3 months prior. 應用以下納入標準：（1） 年齡 2080 歲，（2） 肩痛一個月， >= 1\geq 1 （3） 被動 ROM（外旋或外展）受 >= 30%\geq 30 \% 限，以及 （4） 在肩部外旋或外展的被動終端範圍內有疼痛視覺類比量表 （VAS）。 >= 4\geq 4 我們排除了患有 （1） 嚴重全身性疾病的患者，如中風、帕金森病、甲狀腺疾病、癌症、心肺疾病、風濕性或結締組織疾病（類風濕性關節炎、硬皮病、掌腱膜攣縮症等），或不受控制的糖尿病;（2）患側肩袖鈣化或破裂;（3）肩部骨折或脫位;（4）既往肩部或非肩部手術（心臟、頸椎或胸椎手術）（5）對局部麻醉劑或皮質類固醇過敏史;或 （6） 前 3 個月內對受影響的肩部進行皮質類固醇或透明質酸關節或滑囊注射。
Interventions 干預
Combination group 組合組
Patients in the combination group received hydrodilatation of the affected shoulder and subdeltoid bursa injection twice, with a 2 week interval. Over 8 weeks, the patients also underwent shoulder joint mobilization for 15 min and usual-care physical therapy (therapeutic exercise) for 20 min per session, 3 sessions a week. All treatments were individualized and based on clinical 聯合組患者接受患肩水擴張術和三角肌下滑囊注射2次，間隔2周。在8周內，患者還接受了15分鐘的肩關節活動和每次20分鐘的常規護理物理治療（治療性運動），每周3次。所有治療都是個體化的，基於臨床
evaluation. Two physical therapists with more than 10 years of experience supervised the program. 評估。兩名擁有10多年經驗的物理治療師監督了該計劃。
Injection. Hydrodilatation was performed by injecting a mixture of 10 mg of triamcinolone, 2 mL of 1%1 \% xylocaine, and 17 mL of normal saline in both posterior and anterior glenohumeral joints and 10 mg of triamcinolone and 2 mL of 1%1 \% xylocaine into the subdeltoid bursa of the affected shoulder (see supplimental appendix S1, supplemental figs S1 and S2). All injections were performed under ultrasound guidance by using a 21 -gauge 3 -inch needle for shoulder injection and a 22 -gauge 1.5 -inch needle for subdeltoid bursa injection (supplemental fig S3). ^(24-28){ }^{24-28} 注射。水擴張是通過在盂肱后關節和前盂肱關節注射 10 mg 曲安奈德、2 mL 1%1 \% 賽洛卡因和 17 mL 生理鹽水的混合物以及 10 mg 曲安奈德和 2 mL 1%1 \% 賽洛卡因的混合物注射到受影響肩部的三角肌下滑囊（參見補充附錄 S1，補充圖 S1 和 S2）。所有注射均在超聲引導下進行，使用 21 號 3 英寸針頭進行肩部注射，使用 22 號 1.5 英寸針頭進行三角肌下滑囊注射（補充圖 S3）。 ^(24-28){ }^{24-28}
Mobilization exercise. Specific shoulder joint mobilization involved glenohumeral joint distraction, inferior glide, and posterior glide. ^(20,29){ }^{20,29} 動員演習。特定的肩關節動員包括盂肱關節牽引、下滑動和后滑動。 ^(20,29){ }^{20,29}
Usual-care physical therapy. Stretching (therapeutic exercise) was performed after joint mobilization and physical modality (heat and electrotherapy) application until maximal pain tolerance to the end range of each direction for 20 s , with 10 repetitions. The details of the therapeutic exercises were provided in supplemental appendix S2. 常規護理物理治療。在關節活動和物理方式（熱療和電療）應用後進行拉伸（治療性運動），直到每個方向的末端範圍達到最大疼痛耐受性 20 秒，重複 10 次。治療練習的詳細資訊在補充附錄 S2 中提供。
PT group PT 組
Patients in the PT group underwent heat, electrotherapy, therapeutic exercises, and education similar to those for the combination group. They also received 2 mL of 1%1 \% xylocaine injection in the posterior deltoid muscle twice at a 2 -week interval to mimic injection in the combination group. PT 組患者接受熱療、電療、治療性鍛煉和與聯合組類似的教育。他們還以 2 周的間隔在三角肌后肌中注射 2 mL 1%1 \% 賽洛卡因兩次，以模擬組合組的注射。
After 8 weeks of treatment, we encouraged patients in both groups to continue with the home program and gradually return to their activities of daily living or sports activities. 治療8周后，我們鼓勵兩組患者繼續進行家庭計劃，並逐漸恢復日常生活或體育活動。
Outcome measures 結果測量
The Shoulder Pain and Disability Index (SPADI) was the primary, outcome measure. The secondary outcome measures were pain VAS on maximal active abduction or external rotation of the affected shoulder, active and passive ROM, the Shoulder Disability Questionnaire (SDQ) score, and the 36-item Short-Form Health Survey (SF-36) score. All examinations were performed by a trialblinded assistant. The patients were evaluated before treatment and at 1,2,41,2,4, and 6 months after the beginning of treatment. 肩痛和殘疾指數 （SPADI） 是主要的結果指標。次要結果指標是受影響肩部最大主動外展或外旋的疼痛 VAS、主動和被動 ROM、肩部殘疾問卷 （SDQ） 評分和 36 項簡短健康調查 （SF-36） 評分。所有檢查均由試驗盲法助理進行。患者在治療前、治療開始后 1,2,41,2,4 、 和治療開始后 6 個月接受評估。
Demographic data 人口統計數據
Before randomization, we collected basic data, namely, age, sex, height, weight, body mass index, employment status, sports and leisure activities, the duration of the symptoms, previous treatment, and previous medication for pain control. We also recorded the comorbidities of each participant and their current treatments or medications. 在隨機分組之前，我們收集了基本數據，即年齡、性別、身高、體重、體重指數、就業狀況、運動和休閒活動、癥狀持續時間、既往治療和既往疼痛控制藥物。我們還記錄了每個參與者的合併症以及他們目前的治療或藥物。
Pain and disability 疼痛和殘疾
We used the pain VAS, SPADI, and SDQ questionnaires to evaluate the pain and disability of the affected shoulder. The pain VAS was measured on a 100 mm , with maximum pain being represented by the 100-mm100-\mathrm{mm} point. The patients described their pain during rest and activity (maximal abduction or external rotation of the affected shoulder). ^(30,31){ }^{30,31} The reliability of pain VAS is .94 , but in the absence of a criterion standard for pain, criterion validity cannot be evaluated. ^(31){ }^{31} The SPADI is mainly used to assess shoulder pain and disability. It is divided into 2 subclasses, comprising 5 items for pain and 8 items for disability. Each item is scored from 0 to 100, and the total score is calculated by averaging the scores 我們使用疼痛 VAS、SPADI 和 SDQ 問卷來評估受影響肩部的疼痛和殘疾。疼痛 VAS 在 100 毫米處測量，最大疼痛由點 100-mm100-\mathrm{mm} 表示。患者描述了他們在休息和活動期間的疼痛（受影響肩部的最大外展或外旋）。 ^(30,31){ }^{30,31} 疼痛 VAS 的信度為.94，但在缺乏疼痛標準的情況下，無法評估標準有效性。 ^(31){ }^{31} SPADI 主要用於評估肩部疼痛和殘疾。它分為 2 個子類，包括 5 個疼痛專案和 8 個殘疾專案。每個專案從 0 到 100 打分，總分是通過平均分數計算得出的
for each item. The SPADI is a self-administered questionnaire, and higher scores indicate higher severity. ^(32){ }^{32} The SDQ, a 16 -item pain-related questionnaire, is mainly used to assess the common situations that may induce shoulder pain. The responses are “yes,” “no,” and “not applicable.” The final score is from 0 to 100 , with higher score indicating worse disability. ^(33,34){ }^{33,34} 對於每個專案。SPADI 是一份自填問卷，分數越高表示嚴重程度越高。 ^(32){ }^{32} SDQ 是一份包含 16 個專案的疼痛相關問卷，主要用於評估可能誘發肩痛的常見情況。回答是“是”、“否”和“不適用”。最終分數從 0 到 100，分數越高表示殘疾越嚴重。 ^(33,34){ }^{33,34}
ROM 羅馬
All 4 directions of ROM were measured, including flexion in the sagittal plane, abduction in the frontal plane, and external and internal rotation, with the arm by the side. The measurement tool was a conventional goniometer, and a trained research assistant measured the ROMs throughout the study. ^(35){ }^{35} 測量了 ROM 的所有 4 個方向，包括矢狀面屈曲、額葉外展以及外旋和內旋，手臂在一側。測量工具是傳統的測角儀，訓練有素的研究助理在整個研究過程中測量了 ROM。 ^(35){ }^{35}
Quality of life 生活品質
SF-36, a generic measure of quality of life, contains 8 subscales of health-related components: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale score is from 0 to 100, with higher scores indicating better health. We used a Chineselanguage version of the SF-36, the psychometric properties of which have been established. ^(36){ }^{36} SF-36 是生活品質的通用衡量標準，包含 8 個健康相關組成部分的分量表：身體機能、角色身體、身體疼痛、一般健康、活力、社會功能、角色情感和心理健康。每個分量表分數從 0 到 100，分數越高表示健康情況越好。我們使用了中文版的 SF-36，其心理測量特性已經確定。 ^(36){ }^{36}
Self-assessment of treatment effect 治療效果的自我評估
The patients answered the question “Do you think the treatment is working?” on a 5-point Likert scale (5=very effective, 4=effective, 3=3= not effective, 2=2= worse, and 1=1= much worse; this item was not evaluated at baseline). 患者採用 5 點李克特量表（5 = 非常有效，4 = 有效，無效， 3=3=2=2= 更差，更差 1=1= ，該專案在基線時未評估）回答“您認為治療有效嗎”的問題。
Ultrasonography of the shoulder 肩部超聲檢查
Ultrasound examination of the shoulder was performed with the patient in the sitting position by using a multifrequency 18- to 4MHz linear array probe (Philips EPI Q5). The long head of the biceps and subscapularis, supraspinatus, and infraspinatus tendons were examined sequentially on both transverse and longitudinal scans. The subdeltoid bursa, acromioclavicular joint, humeral head, and some parts of the glenoid labrum were also examined. ^(28){ }^{28} 使用多頻 18 至 4MHz 線性陣列探頭（飛利浦 EPI Q5）在患者坐姿下對肩部進行超聲檢查。在橫向和縱向掃描中依次檢查二頭肌和肩胛下肌、岡上肌和岡下肌腱的長頭。還檢查了三角肌下滑囊、肩鎖關節、肱骨頭和關節盂盂唇的某些部分。 ^(28){ }^{28}
Sample size calculation 樣本量計算
Sample size was calculated using G*power (version 3.1.9.4; February 6,2019 , release, Germany). The repeated-measures within -between interaction was used to calculate the sample size, and effect size ff was .25 . The chance of correctly rejecting the null hypothesis was 80%80 \%. To allow a dropout or loss to follow-up rate of 35%,3535 \%, 35 patients per group were enrolled. 樣本量使用 G*power（版本 3.1.9.4;2019 年 2 月 6 日，德國發佈）。採用交互作用內的重複測量來計算樣本量，效應量 ff 為.25。正確拒絕原假設的幾率是 80%80 \% 。為了允許每組 35%,3535 \%, 35 患者的輟學或失訪率，被納入。
Statistical analysis 統計分析
Categorical variables are presented as numbers and percentages, and continuous variables are presented as means and standard deviations. The chi-square test was used to compare sex, history of diseases, leisure activities, and exercise habits. We used the Kolmogorov-Smirnov test to test the normality. The Mann-Whitney UU test was used to compare age, height, weight, body mass index, pain duration, pain VAS scores, SPADI score, SDQ score, and ROM at baseline. For the pain VAS scores, SPADI, and ROM, the Mann-Whitney U\boldsymbol{U} was used to evaluate between-subject effects (group: combination and PT groups) and within-subject effects (evaluation time: pretreatment and 1,2,41,2,4, and 6 months poststart) on the basis of the intention-to-treat principle. Statistical 分類變數以數位和百分比表示，連續變數以均值和標準差表示。卡方檢驗用於比較性別、病史、休閒活動和運動習慣。我們使用柯爾莫哥洛夫-斯米爾諾夫檢驗來檢驗正態性。Mann-Whitney UU 檢驗用於比較基線時的年齡、身高、體重、體重指數、疼痛持續時間、疼痛 VAS 評分、SPADI 評分、SDQ 評分和 ROM。對於疼痛 VAS 評分、SPADI 和 ROM，採用 Mann-Whitney U\boldsymbol{U} 法評估受試者間效應（組：聯合組和 PT 組）和受試者內效應（評估時間：治療前和 1,2,41,2,4 開始后 6 個月）基於意向治療原則。統計
This study was supported by the National Science and Technology Council of Taiwan (MOST 109-2314-B341-002 and MOST 110-2314-B-341-002). 本研究得到臺灣國家科學技術委員會（MOST 109-2314-B341-002 和 MOST 110-2314-B-341-002）的支援。
Clinical trial registration: ClinicalTrials (no. NCT04474145). 臨床試驗註冊：ClinicalTrials（no.NCT04474145）。
Disclosures: The authors disclose no conflict of interest. 披露：作者沒有披露利益衝突。