Effects of Aerobic Exercise on Shoulder Pain, Disability, and Ultrasonographic Outcomes in Patients With Type 2 Diabetes Mellitus With Supraspinatus Tendinopathy
Effects of Aerobic Exercise on Shoulder Pain, Disability, and Ultrasonographic Outcomes in Patients With Type 2 Diabetes Mellitus With Supraspinatus Tendinopathy :A Randomized Controlled Trial
Type 2 diabetes mellitus (T2DM) is a chronic disease characterized by elevated blood glucose levels over a prolonged period. If left untreated, it can lead to serious and long-term vascular and neurological complications. It is also a major cause of morbidity due to specific microvascular complications (retinopathy, nephropathy, and neuropathy), macrovascular complications (ischemic heart disease, stroke, and peripheral vascular disease), and reduced quality of life.
There are studies in the literature investigating conventional and shoulder-specific treatments for various shoulder pathologies in patients with type 2 diabetes mellitus (T2DM) . However, very few studies have investigated the effectiveness of aerobic exercise. The investigators identified only one study that evaluated the effects of aerobic exercise on pain and range of motion in patients with T2DM and adhesive capsulitis.
In the present study, the investigators aim to demonstrate that aerobic exercise results in statistically significant improvements in shoulder pain, functional disability, and the structural characteristics of the supraspinatus tendon, as assessed by ultrasonography and elastography, in participants with T2DM and supraspinatus tendinopathy. The investigators believe that the findings of this study will provide scientific evidence to support the development of more effective and comprehensive rehabilitation protocols for participants with diabetes and shoulder pain.
調査の概要
状態
詳細な説明
Type 2 diabetes mellitus (T2DM) is a chronic disease characterized by persistently elevated blood glucose levels. If left untreated, it can lead to serious long-term vascular and neurological complications. T2DM is also an important cause of morbidity due to microvascular complications, including retinopathy, nephropathy, and neuropathy; macrovascular complications, including ischemic heart disease, stroke, and peripheral vascular disease; and reduced quality of life.
In addition to its metabolic effects, T2DM has significant effects on the musculoskeletal system. Musculoskeletal disorders such as tendinopathy, entrapment neuropathies, and osteoarthritis have been reported to occur more frequently and with greater severity in patients with T2DM. Although musculoskeletal disorders in patients with diabetes have received relatively limited attention in the literature, they can contribute to both physical and psychological morbidity and substantially impair patients' quality of life.
Current evidence suggests two main pathophysiological mechanisms underlying the development of diabetic shoulder disorders. The first involves connective tissue degeneration in the rotator cuff and joint capsule, while the second is associated with peripheral or autonomic neuropathy. Recent studies have shown that advanced glycation end products (AGEs), which develop as a result of chronic hyperglycemia, accumulate in tissues and increase cross-linking between collagen fibers. This process disrupts collagen architecture and compromises the structural integrity and biomechanical properties of connective tissue .
Aerobic exercise has been shown to be one of the most effective approaches for improving glycemic control, reducing cardiovascular risk factors, promoting weight loss, and enhancing overall well-being . Therefore, aerobic exercise may serve as an important adjunctive treatment in musculoskeletal rehabilitation programs for patients with diabetes. However, very few studies have investigated the effectiveness of aerobic exercise in patients with diabetes who have specific musculoskeletal disorders . Furthermore, most clinical studies focusing on shoulder rehabilitation have been conducted either in individuals without diabetes or in patients with diabetes who have a specific shoulder condition, such as adhesive capsulitis, with limited attention given to other shoulder disorders .
The limited research in this area may be partly due to the clinical prioritization of more life-threatening complications of diabetes, such as cardiovascular diseases. However, musculoskeletal disorders can reduce physical mobility, increase morbidity, and impose a substantial burden on quality of life in this patient population . Therefore, further research is needed to better understand whether adding aerobic exercise to standard shoulder rehabilitation programs can help reduce musculoskeletal complications in individuals with diabetes.
Previous studies have investigated conventional and shoulder-specific treatment approaches for various shoulder disorders in patients with type 2 diabetes mellitus (T2DM) . However, evidence regarding the effectiveness of aerobic exercise in this patient population remains limited. To date, only one study has evaluated the effects of aerobic exercise on pain and range of motion in patients with T2DM and adhesive capsulitis.The present study aims to investigate whether the addition of aerobic exercise results in significant improvements in shoulder pain, functional disability, and the structural characteristics of the supraspinatus tendon, as assessed by ultrasonography and elastography, in patients with T2DM and supraspinatus tendinopathy. The findings of this study are expected to provide scientific evidence for the development of more effective and comprehensive rehabilitation strategies for patients with diabetes and shoulder pain.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Melike LALE, MD
- 電話番号：+905357822420
- メール：melikesalar1@gmail.com
研究場所
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Denizli、トルコ（Türkiye）
- Pamukkale University, Denizli
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コンタクト：
- Melike LALE, MD
- 電話番号：+905357822420
- メール：melikesalar1@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Aged 30-70 years.
- Having a diagnosis of type 2 diabetes mellitus (T2DM) for more than 1 year.
- Having unilateral or bilateral shoulder pain for at least 3 months and a diagnosis of supraspinatus tendinopathy confirmed by magnetic resonance imaging (MRI).
- Having a pain intensity score of ≥3 on the Visual Analog Scale (VAS).
- No participation in regular exercise during the past 6 months
Exclusion Criteria:
- Having received shoulder rehabilitation within the past 6 months.
- Having a full-thickness tear of the supraspinatus tendon.
- Having a history of fracture, surgery, or injection in the upper extremity within the past 6 months.
- Having a diagnosis of a neuromuscular disease, rheumatic disease, or severe cardiovascular disease.
- Having advanced diabetic complications.
- Having any condition that contraindicates or prevents participation in aerobic exercise.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：Conventional Rehabilitation
Conventional physical therapy will be administered 5 sessions per week for a total of 30 sessions. The treatment program will include 20 minutes of heat therapy, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS), 5 minutes of therapeutic ultrasound at an intensity of 1.5 W/cm², and shoulder-specific exercises performed under the supervision of a physiotherapist. The supervised exercise program will include pendulum exercises, range-of-motion exercises, posterior capsule and pectoral stretching, scapular stabilization exercises, and strengthening exercises for the rotator cuff muscles . |
Conventional physical therapy will be administered 5 days per week for 6 weeks (30 sessions).
The program will include heat therapy, TENS, therapeutic ultrasound, and supervised shoulder-specific exercises, including range-of-motion, stretching, scapular stabilization, and rotator cuff strengthening exercises.
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実験的：Conventional Physical Therapy + Aerobic Exercise
In addition to the conventional shoulder rehabilitation protocol, participants will receive an aerobic exercise program. The aerobic exercise program will be implemented in accordance with the current physical activity and exercise recommendations of the American Diabetes Association. Participants will perform moderate-intensity treadmill walking 5 days per week for 30 minutes per session, at an intensity corresponding to 50-60% of heart rate reserve. Each session will consist of a 5-minute warm-up, 20 minutes of aerobic exercise on the treadmill, and a 5-minute cool-down. After the fourth week, the exercise duration will be increased to 40 minutes per session, consisting of a 5-minute warm-up, 30 minutes of aerobic exercise on the treadmill, and a 5-minute cool-down. All exercise sessions will be performed under the supervision of a physiotherapist and in accordance with appropriate safety protocols . The treatment program will be administered for a total of 6 weeks. |
In addition to conventional shoulder rehabilitation, participants will perform moderate-intensity treadmill aerobic exercise (50-60% of heart rate reserve) 5 days per week for 6 weeks.
Sessions will initially last 30 minutes (5-minute warm-up, 20-minute exercise, and 5-minute cool-down) and will increase to 40 minutes after Week 4. All sessions will be supervised by a physiotherapist and conducted according to appropriate safety protocols.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Shoulder Pain Assessed by Visual Analog Scale (VAS)
時間枠：Baseline (Week 0) and post-treatment (Week 6)
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Shoulder pain intensity will be assessed using the Visual Analog Scale (VAS).
Participants will rate their pain on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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Baseline (Week 0) and post-treatment (Week 6)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index (SPADI)
時間枠：Baseline (Week 0) and post-treatment (Week 6)
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Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index (SPADI), a 13-item self-reported questionnaire consisting of 5 items assessing pain and 8 items assessing disability.
The total SPADI score ranges from 0% to 100%, with higher scores indicating greater pain and disability.
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Baseline (Week 0) and post-treatment (Week 6)
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Supraspinatus Tendon Thickness Assessed by Ultrasonography
時間枠：Baseline (Week 0) and post-treatment (Week 6)
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Supraspinatus tendon thickness will be assessed using ultrasonography with an 8-13 MHz linear transducer.
Measurements will be obtained in the modified Crass position with the tendon visualized in the transverse plane.
Tendon thickness will be measured at 10, 15, and 20 mm from the reference point lateral to the long head of the biceps tendon.
The mean of the three measurements will be recorded as the supraspinatus tendon thickness, with higher values indicating greater tendon thickness.
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Baseline (Week 0) and post-treatment (Week 6)
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Supraspinatus Tendon Stiffness Assessed by Strain Elastography
時間枠：Baseline (Week 0) and post-treatment (Week 6)
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Supraspinatus tendon stiffness will be assessed using strain elastography with an 8-13 MHz linear transducer.
Measurements will be obtained in the longitudinal plane with the transducer positioned in the coronal plane over the anterior aspect of the acromion.
Elastographic measurements will be obtained from medial, middle, and lateral regions, with the deltoid muscle used as the reference tissue.
Changes in elastographic measurements will be used to evaluate tendon mechanical properties.
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Baseline (Week 0) and post-treatment (Week 6)
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Central Sensitization Inventory (CSI)
時間枠：Baseline (Week 0) and post-treatment (Week 6)
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Central sensitization will be assessed using the Central Sensitization Inventory (CSI).
The CSI is a 25-item self-report questionnaire developed to assess the severity of symptoms associated with central sensitization.
Each item is scored from 0 (never) to 4 (always), with a total score ranging from 0 to 100.
Higher scores indicate greater severity of central sensitization-related symptoms.
The Turkish version of the CSI has demonstrated good validity and reliability and has been reported to be suitable for use in clinical conditions associated with chronic pain.
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Baseline (Week 0) and post-treatment (Week 6)
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Alev ATIGAN, Assistant Professor、Pamukkale University
出版物と役立つリンク
一般刊行物
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研究の完了 (推定)
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追加の関連 MeSH 用語
その他の研究ID番号
- PamukkaleU.ftr-AATIGAN-001
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