Abstract
Type 2 diabetes mellitus (T2DM) is associated with various musculoskeletal disorders, including frozen shoulder (FS), a condition marked by pain and restricted movement. FS is more common in T2DM patients, with increased severity and longer recovery time. Chronic inflammation, collagen accumulation, and hyperglycemia-induced changes contribute to FS development in T2DM limiting daily activities and may hinder diabetes management by restricting self-care tasks. Early detection and timely intervention may improve outcomes and enhance quality of life. Existing shoulder assessment questionnaires are often lengthy, complex, and require physician intervention, limiting their use in routine practice. To address this, a concise, patient-administered screening questionnaire has been proposed for patients with T2DM. This six-question tool covers shoulder pain, movement limitations, and sleep disruption, thus potentially offering a quick, effective method for early FS screening in routine practice settings. Further validation in real-world settings will assess the clinical utility of this screening tool.
Keywords: Early screening, frozen shoulder, questionnaire, type 2 diabetes mellitus
INTRODUCTION
Type 2 diabetes mellitus (T2DM), a chronic metabolic disorder resulting in hyperglycemia, accounts for around 90% of diabetes mellitus (DM) cases.[1,2,3] As reported by the Indian Council of Medical Research–India Diabetes (ICMR-INDIAB) study, an overall weighted prevalence of diabetes in Indian adults is 11.4%.[4] Untreated T2DM leads to various chronic micro and macrovascular complications.[5]
Musculoskeletal complications are common in diabetes, with a reported prevalence of 58.15%.[6] Among musculoskeletal diseases, conditions affecting the hand and shoulder are more commonly observed in individuals with diabetes.[7] Molsted et al. reported twice as high incidence of musculoskeletal complaints in T2DM patients compared with controls.[8] Frozen shoulder (FS) or adhesive capsulitis (AC) is common musculoskeletal disorder.[9] It is a painful condition causing shoulder stiffness and restricted movement.[10] While more common in diabetes patients based on age and disease duration, no standard diagnostic criteria exist for them.[11] Diagnosis of FS relies on clinical symptoms and physical examination.[12] Prognosis is poorer in diabetes patients, with more severe symptoms and treatment resistance, highlighting the need for early management.[13,14] Early diagnosis is crucial in FS management, leading to reduced pain, shorter treatment duration, and better response.[15] Unaddressed FS can eventually restrict the range of movements negatively affecting quality of life of T2DM patients.[16,17]
This review emphasizes early FS diagnosis in patients with T2DM for better clinical outcomes and proposes a concise clinic-based screening questionnaire for timely screening of FS among people with T2DM.
METHODOLOGY
Articles were identified through searches of PubMed, Scopus, and Google Scholar, covering the period from January 1900 to January 2025. Keywords included “type 2 diabetes mellitus,” “frozen shoulder,” “adhesive capsulitis,” “musculoskeletal complications,” and “screening tools.” Studies were included if they were published in English, focused on adult humans, and addressed the epidemiology, pathophysiology, or clinical assessment of FS in patients with T2DM. Priority was given to clinical trials, reviews, and studies evaluating patient-reported outcome measures. Data were synthesized to identify common clinical features and inform the design of a concise, patient-administered screening questionnaire for use in routine diabetes care.
Experts reviewed and rated the proposed questionnaire items with respect to their clinical relevance, clarity, and ease of use. Based on their feedback, some items were retained while others were revised or removed. A formal Delphi process and calculation of a content validity index were not undertaken; instead, the refinement was based on qualitative expert consensus.
TYPE 2 DIABETES MELLITUS AND fROZEN SHOULDER: A LOOK INTO THE CROSSTALK
Chronic inflammation in musculotendinous/synovial tissue (rotator cuff, biceps tendon, or joint capsule) leads to the development of FS. The capsule that surrounds the shoulder joint (glenohumeral joint) contracts and shoulder mobility becomes limited and painful in this condition.[18] As a result, severe decreases in forward elevation and external rotation are the primary characteristics of the disease.[19] In addition, adherent axillary recess and tightness in the joint capsule limits the range of motion (ROM) of the shoulder.[20] The pathogenesis of FS primarily comprises three phases: (i) the freezing phase, which is an initial painful phase lasting 2–9 months during which individuals experience severe shoulder pain; (ii) the frozen phase, which lasts 4–12 months when pain reduces but the ROM of the shoulder joint gradually decreases; and (iii) the thawing phase, lasting 5 months to 2 years, during which the ROM of the shoulder joint gradually increases.[21] Several risk factors, including female gender and diabetes duration have been linked to the higher incidence of FS.[21] Moreover, diabetes is one of the significant risk factors for the development of FS.[22] Capsular fibrosis and contracture can be caused by the glycation and inflammatory processes associated with diabetes, which lead to the occurrence of FS.[23] Moreover, pathological alterations such as oxidative stress, inflammation, and microangiopathy are primarily responsible for the notable rise in the incidence of FS in individuals with diabetes. These pathological changes raise the levels of cytokines in the tendons, muscles, soft tissues, and joint capsules, causing an inflammatory and fibrotic response around the shoulder joint [Figure 1].[19,21,22,24] Furthermore, increased oxidative stress and inflammation lead to the formation of advanced glycation end products (AGEs) in the shoulder joint, resulting in reduced mobility and joint pain.[22] Moreover, hyperglycemia in diabetes causes an increase in Intercellular Adhesion Molecule-1, which plays a crucial role in the immune system-mediated inflammatory response.[14] The hyperglycemic state in T2DM also contribute to alterations in the collagen matrix in the shoulder joint resulting in fibrotic and inflammatory changes.[24] Fibrotic changes include proliferation of fibroblast and transformation of some myofibroblast. As a result, formation of excess type I and type III collagen along with contraction of joint capsule results into pain and stiffness in glenohumeral joint.[10]
Figure 1.
Pathophysiology of FS in patient with diabetes. AGE = Advanced glycation end products, FS = Frozen shoulder, ICAM = Intercellular adhesion molecule-1, T2DM = Type 2 diabetes mellitus
EPIDEMIOLOGY
The reported prevalence of FS in T2DM patients from different studies ranges from 12% to 29%.[12,25,26,27] In a cross-sectional study by Aydeniz et al., higher prevalence of FS is reported in individuals with T2DM as compared with individuals without diabetes (14.7% vs. 3.9%).[25]
A cross-sectional study by Gharge et al. reported a higher prevalence of FS (52%) among other musculoskeletal disorders (Carpel tunnel syndrome, 32%; Trigger finger, 9%; Charcot joint, 4%; and Dupuytren’s contracture, 3%) in individuals with T2DM from India.[7] Huan et al. in the longitudinal population-based study reported a higher risk of FS in individuals with diabetes as compared with patients without diabetes (4.92 vs. 3.67 per 1000 person-year P < 0.0001).[28] Dyer et al. in a meta-analysis of six case-control studies, including 5,388 subjects showed higher odds (odds ratio [OR] = 3.69; 95% confidence interval [CI] [2.99–4.56]) of developing FS in individuals with diabetes than the control group.[23]
FROZEN SHOULDER IN DIABETES AND POTENTIAL CONSEQUENCES
Research revealed that compared with patients without diabetes, patients with diabetes had more severe forms of conditions, including worse ROM, higher residual pain, and inferior functions (activities of daily living).[29,30,31,32] People with diabetes do not always follow the natural history of idiopathic FS and more often require intervention compared with patients without diabetes.[30,32] Pain can be brought on by day-to-day activities and sudden movements. Patients often describe a ‘sickening’ pain if their arm is jarred or pulled in any direction.[32] According to Massoud et al., 21.3% of patients with diabetes having FS had limited ROM with difficulties in daily activities.[33] The condition may result in difficulty in sleeping on the affected side.[32]
American College of Sports Medicine and American Diabetes Association recommended a focus on frequency and intensity of exercise which impact glycemic control in patients with T2DM.[34] As per guidelines, (i) regular flexibility training to maintain ROM of the joint, (ii) stretching in between warm-ups or after completion of the activity to increase ROM, and (iii) resistance training to strengthen the muscles around the affected joint are recommended in diabetes patient. However, the exercise training recommendations primarily depend upon the type of exercise, intensity, duration, and frequency.[34]
Comorbid chronic pain is major limiting factor in the performance of self-care behaviors in diabetes patients and is strongly associated with specific diabetes self-care activities, including greater difficulty with exercise (adjusted OR = 3.0; 95% CI (2.1–4.1); P = 0.002) and following a recommended eating plan (adjusted OR = 1.6; 95% CI [1.2–2.1]; P = 0.002). Among patients with chronic pain, overall self-management of diabetes is reported to be significantly poorer in patients with severe or very severe pain compared with those who rated their pain as mild or moderate (adjusted OR = −5.7; 95% CI [−8.3–−2.1]; P = 0.003). Specifically, patients with severe pain reported more difficulty with taking diabetes medications (adjusted OR = 2.0; 95% CI [1.2–3.4]; P = 0.003) and with exercise (adjusted OR = 2.5; 95% CI [1.3–5.0]; P = 0.003).[16] Studies revealed that, people with shoulder disorder may experience the chronic pain and restricted ROM, which may potentially affect diabetes self-management and quality of life in patients with diabetes.[17]
IMPORTANCE OF EARLY SCREENING OF FROZEN SHOULDER
FS is primarily diagnosed based on clinical signs and symptoms, such as progressive shoulder pain, restricted active and passive ROM, and functional limitations. However, in some cases, imaging modalities such as X-ray, magnetic resonance imaging (MRI), and ultrasound are used to support the diagnosis and rule out other causes of shoulder stiffness, such as osteoarthritis or rotator cuff tears.[35]
Plain radiographs (X-rays) are typically normal in FS but are useful in excluding other pathologies like glenohumeral arthritis or calcific tendinitis. Subtle findings may include osteopenia or joint space narrowing in chronic cases.[36]
Ultrasound can aid in detecting thickening of the coracohumeral ligament and synovial hypertrophy in the rotator cuff interval, which are suggestive of AC. It is also useful in evaluating associated pathologies such as rotator cuff tendinopathy or bursitis.[37]
MRI and MR arthrography demonstrate higher diagnostic accuracy by identifying several hallmark features of FS. These include hyperintensity and thickening of the inferior glenohumeral ligament, thickened coracohumeral ligament, poor capsular distension, synovial hypertrophy, and fibrotic tissue at the rotator interval.[37,38]
Vita et al. reported that early FS detection is crucial to prevent the disease progression from stage I to stage II, which help to reduce treatment duration and improving outcomes.[15] In addition, early diagnosis of FS in diabetes patients can allow better management of both conditions.[39] In patients without diabetes, FS was mostly diagnosed at stage I and stage II, however, in diabetes patients, FS was diagnosed at stage II and stage III. The shoulder pain in these patients is sometime perceived as generalized weakness and muscular pain which occur in the course of high blood sugar in diabetes, and this is considered as one of the reasons for the delayed diagnosis.[40]
Several studies suggest that clinicians treating diabetes patients should routinely enquire about shoulder pain and other musculoskeletal complaints during follow-up appointments to facilitate early diagnosis and appropriate treatment.[7,23,27] Screening for FS in T2DM patients is pivotal considering the prevalence and severity of the condition.[12,25,26,27,29,30,31,32] Timely screening of FS can facilitate early diagnosis and intervention for FS. Additionally, timely intervention may hinder negative impact of FS on diabetes self-management. Therefore, early screening of FS is crucial in T2DM patients.
EXISTING TOOLS FOR ASSESSMENT OF SHOULDER DISORDERS
There are multiple tools which have been used to assess the disability and pain associated with shoulder disorders or to assess the outcomes of shoulder surgeries such as Shoulder and Pain Disability Index (SPADI),[41] Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH),[42] Oxford Shoulder Score (OSS),[43] University of California at Los Angeles (UCLA) Shoulder Rating Scale.[44] SPADI, a 13-item self-reported questionnaire where each item is scored on a ten-point Likert scale, has been developed to measure the pain and disability associated with shoulder pathology.[41] Venturin et al. reported that SPADI is a commonly used tool for assessing the pain and disability in individuals with FS.[45] DASH is a 30-item, self-reported questionnaire developed to measure the disability experienced by people with disorders in the upper limb. Each item is scored on a five-point Likert scale.[42] Baets et al. used DASH for assessing arm function in patient with FS.[46] OSS is 12-item questionnaire for completion by patients having shoulder operations other than stabilization. Each item is scored on four-point scale.[43] It is used to assess the outcomes of shoulder surgery and the impact of shoulder ailments on a patient’s quality of life.[47,48] UCLA shoulder rating scale is used to assess the clinical outcomes after total shoulder arthroplasty, where patient is contacted to assess for satisfaction, shoulder pain, function, ROM, and strength. However, it is not a patient self-report assessment tool completely, as responses for ROM and strength section are to be reported by physician.[44] UCLA and its modified version have been used for assessment of shoulder dysfunction in diabetes patients.[5,49]
NEED FOR A DEVELOPMENT OF SCREENING QUESTIONNAIRE
Existing questionnaires are developed for assessment of pain and disabilities or treatment outcomes in the patients already clinically diagnosed with shoulder disorders and not designed for screening purposes. In addition, these questionnaires have some limitations such as being lengthy and complex, some need physician intervention for recording the responses from patients. Hence, these tools have limited applicability for being integrated into routine clinical practice for screening of FS. Moreover, screening tools for FS, specifically tailored for T2DM patients are lacking, which underscores the need for the development of screening tool. Therefore, the task to develop a concise, patient-administered self-assessment tool, tailored for T2DM patients was undertaken by the expert group. This would enable early screening of FS in this population in routine practice settings and can seamlessly integrate into standard clinical practice for diabetes care, and consequently lead to prompt diagnosis and early intervention.
To develop this tool, a structured, multi-step process was followed. Initially, a comprehensive review of the existing literature was conducted to identify the most commonly reported clinical features of FS, as well as limitations in currently available assessment methods. Following this, a series of structured expert opinion meetings were organized involving a panel of leading endocrinologists and diabetologists from across India. During these meetings, background evidence was presented and moderated discussions were held to reach a consensus on the most clinically relevant and patient-recognizable symptoms of FS. In each round, experts reviewed and rated proposed questionnaire items for clinical relevance, clarity, and ease of use. Items that reached strong agreement among the panel were retained, while others were revised or eliminated based on feedback. The final version of the screening tool consisted of six questions designed to be self-administered by patients [Table 1].
Table 1.
Proposed questionnaire for screening of frozen shoulder in Type 2 diabetes mellitus individuals
| Questions | Options |
|---|---|
| Please choose the appropriate response to each question. | |
| 1. Have you noticed any swelling around your shoulder joint, or do you have a history of shoulder injury? (No scoring for this question) | □ Yes □ No |
| 2. Do you experience pain in your shoulder? | □ Yes, continuously (more than 12 hours a day) (Score 2) □ Yes, occasionally (up to 12hours in a day) (Score 1) □ No (Score 0) |
| 3. Has your shoulder movement been restricted, making it difficult to perform daily activities such as | |
| i. Washing your hair? | □ Yes, frequently (Score 2) □ Yes, occasionally (Score 1) □ No (Score 0) |
| ii. Washing your back? | □ Yes, frequently (Score 2) □ Yes, occasionally (Score 1) □ No (Score 0) |
| iii. Putting on a shirt/T shirt/Top? | □ Yes, frequently (Score 2) □ Yes, occasionally (Score 1) □ No (Score 0) |
| iv. Placing an object on a high shelf? | □ Yes, frequently (Score 2) □ Yes, occasionally (Score 1) □ No (Score 0) |
| 4. Have you noticed any tenderness (pain upon touching) around your shoulder joint? | □ Yes, significantly (Score 2) □ Yes, occasionally (Score 1) □ No (Score 0) |
| 5. Are these symptoms impacting your sleep quality? | □ Yes, significantly (Score 2) □ Yes, occasionally (Score 1) □ No (Score 0) |
| 6. Are these symptoms impacting your ability to exercise? | □ Yes, significantly (Score 2) □ Yes, occasionally (Score 1) □ No (Score 0) |
| Scoring: | |
| • No scoring for question 1. | |
| • If the response to question 1 is Yes, the patient will consult the doctor. | |
| • If the response to question 1 is No, the patient will be directed to respond to questions 2 to 4. | |
| • If the response to any question among questions 2 to 4 is Yes (i.e., if score is greater than 0 for any question among questions 2 to 4), then the patient will be directed to respond to questions 5 and 6. | |
| • The total score will range from 0 to 16, with a higher score indicating a higher likelihood of FS. | |
| • Score 0–5: Low likelihood of FS | |
| • Score 6–16: Higher likelihood of FS; individual should consult their doctor. | |
Responses to these items were recorded using either a binary (Yes/No) scale or a 3-point Likert-type scale, depending on the nature of the question. The cumulative score ranges from 0 to 16, with a score of ≥6 indicating a higher likelihood of FS in the individual and suggesting the need for further evaluation by a healthcare professional. This preliminary tool is intended to serve as a simple and efficient FS screening aid in diabetes clinics and in general practice. Further, to evaluate the therapeutic impact of the developed questionnaire tool, real-world validation would be required.
CONCLUSION
FS is a prevalent and severe complication in patients with T2DM, often leading to pain, reduced ROM, and challenges in diabetes management. Early detection and intervention are critical to improving clinical outcomes and enhancing quality of life. Current tools have limitations, highlighting the need for a concise, patient-administered screening tool specifically designed for T2DM patients. The proposed questionnaire offers an imperative approach for early identification of FS in clinical practice, potentially facilitating early diagnosis and timely treatment.
Author contributions
All named authors met the International Committee of Medical Journal Editors (ICMJE) criteria for authorship, take responsibility for the integrity of the work, and have given their approval for this version to be published. The content published herein solely represents the views and opinions of the authors and does not necessarily represent the views or opinions of Cipla and/or its affiliates.
Conflicts of interest
There are no conflicts of interest.
Use of artificial intelligence
Artificial intelligence was not used in any form for analysis or writing of this research article.
Acknowledgment
The authors express their gratitude to Dr. Sushama Patil, Mr. Rahul Iyer, and Dr. Amarnath Sugumaran from the Department of Medical Affairs, Cipla Ltd, Mumbai, for their logistics assistance, guidance and expertise in convening an expert forum meeting. The authors also thank Pradnya Anand (Sqarona Medical Communications LLP, Pune) for medical writing and editorial support and paid for by Cipla Ltd, India.
Funding Statement
This initiative has been supported by Cipla Ltd, India.
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