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NCT Number: NCT07784543

Effects of Aerobic Exercise on Shoulder Pain, Disability, and Ultrasonographic Outcomes in Patients With Type 2 Diabetes Mellitus With Supraspinatus Tendinopathy

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. We 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 this study, we 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 patients with T2DM and supraspinatus tendinopathy. We believe that the findings of this study will provide scientific evidence to support the development of more effective and comprehensive rehabilitation protocols for patients with diabetes and shoulder pain.

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Key information

About this study

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 our knowledge, 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional Shoulder Rehabilitation

Behavioral

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.

Aerobic Exercise

Behavioral

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.

Primary outcomes

  1. Shoulder Pain Assessed by Visual Analog Scale (VAS)

    Time frame: Baseline (Week 0) and post-treatment (Week 6)

    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.

Secondary outcomes

  1. Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index (SPADI)

    Time frame: Baseline (Week 0) and post-treatment (Week 6)

    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.

  2. Supraspinatus Tendon Thickness Assessed by Ultrasonography

    Time frame: Baseline (Week 0) and post-treatment (Week 6)

    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.

  3. Supraspinatus Tendon Stiffness Assessed by Strain Elastography

    Time frame: Baseline (Week 0) and post-treatment (Week 6)

    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.

  4. Central Sensitization Inventory (CSI)

    Time frame: Baseline (Week 0) and post-treatment (Week 6)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melike LALE, MD

CONTACT

[email protected]

+905357822420

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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