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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorPamukkale University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Conventional RehabilitationActive comparator 1 intervention
Group B: Conventional Physical Therapy + Aerobic ExerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Shoulder Pain Assessed by Visual Analog Scale (VAS)

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.

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

Secondary outcomes

1

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

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.

Time frame
Baseline (Week 0) and post-treatment (Week 6)
2

Supraspinatus Tendon Thickness Assessed by Ultrasonography

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.

Time frame
Baseline (Week 0) and post-treatment (Week 6)
3

Supraspinatus Tendon Stiffness Assessed by Strain Elastography

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.

Time frame
Baseline (Week 0) and post-treatment (Week 6)
4

Central Sensitization Inventory (CSI)

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.

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

Other outcomes

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