Supraspinatus TendinopathyNCT07784543
Effects of Aerobic Exercise on Shoulder Pain, Disability, and Ultrasonographic Outcomes in Patients With Type 2 Diabetes Mellitus With Supraspinatus Tendinopathy
A study testing Conventional Shoulder Rehabilitation and Aerobic Exercise in people with Supraspinatus Tendinopathy and Type 2 Diabetes Mellitus (T2DM), run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Supraspinatus Tendinopathy, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Conventional Shoulder Rehabilitation and Aerobic Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2026to 25 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Pamukkale University, Denizli
Denizli
Melike LALE, MD, +905357822420, melikesalar1@gmail.com
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Conventional Shoulder Rehabilitation, Aerobic Exercise
- Keywords
- Shoulder Pain, Aerobic Exercise, Supraspinatus Tendinopathy, Type 2 Diabetes Mellitus, Ultrasonography, Physical Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Shoulder RehabilitationBehavioural
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 ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabilitation | Active comparator | 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 . Receives: Behavioral: Conventional Shoulder Rehabilitation |
| Conventional Physical Therapy + Aerobic Exercise | Experimental | 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. Receives: Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and post-treatment (Week 6)
Secondary outcomes (4)
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.
Measured: Baseline (Week 0) and post-treatment (Week 6)
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.
Measured: Baseline (Week 0) and post-treatment (Week 6)
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.
Measured: Baseline (Week 0) and post-treatment (Week 6)
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.
Measured: Baseline (Week 0) and post-treatment (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start25 Aug 2026 (estimated)
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Supraspinatus TendinopathyStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alev Atıgan, Pamukkale University
- Investigators
- Alev ATIGAN, Assistant Professor, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784543
- Sponsor's protocol ID
- PamukkaleU.ftr-AATIGAN-001
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.
PubMed 21951710Brage K, Hjarbaek J, Kjaer P, Ingwersen KG, Juul-Kristensen B. Ultrasonic strain elastography for detecting abnormalities in the supraspinatus tendon: an intra- and inter-rater reliability study. BMJ Open. 2019 May 9;9(5):e027725. doi: 10.1136/bmjopen-2018-027725.
PubMed 31072860BaGcier F, Geler KUlcU D, Yorulmaz E, Altunok EC. Intra- and Inter-Rater Reliability of Ultrasound Measurements of Supraspinatus Tendon Thickness, Acromiohumeral Distance, and Occupation Ratio in Patients With Shoulder Impingement Syndrome. Arch Rheumatol. 2020 Feb 7;35(3):385-393. doi: 10.46497/ArchRheumatol.2020.7515. eCollection 2020 Sep.
PubMed 33458662Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991 Dec;4(4):143-9.
PubMed 11188601Luque-Suarez A, Rondon-Ramos A, Fernandez-Sanchez M, Roach KE, Morales-Asencio JM. Spanish version of SPADI (shoulder pain and disability index) in musculoskeletal shoulder pain: a new 10-items version after confirmatory factor analysis. Health Qual Life Outcomes. 2016 Mar 1;14:32. doi: 10.1186/s12955-016-0436-4.
PubMed 26927584Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, Horton ES, Castorino K, Tate DF. Physical Activity/Exercise and Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Nov;39(11):2065-2079. doi: 10.2337/dc16-1728. No abstract available.
PubMed 27926890ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Gibbons CH, Giurini JM, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Sun JK, Gabbay RA, on behalf of the American Diabetes Association. 12. Retinopathy, Neuropathy, and Foot Care: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S203-S215. doi: 10.2337/dc23-S012.
PubMed 36507636Yang JL, Chang CW, Chen SY, Wang SF, Lin JJ. Mobilization techniques in subjects with frozen shoulder syndrome: randomized multiple-treatment trial. Phys Ther. 2007 Oct;87(10):1307-15. doi: 10.2522/ptj.20060295. Epub 2007 Aug 7.
PubMed 17684085Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.
PubMed 28630217Mueller MJ, Sorensen CJ, McGill JB, Clark BR, Lang CE, Chen L, Bohnert KL, Hastings MK. Effect of a Shoulder Movement Intervention on Joint Mobility, Pain, and Disability in People With Diabetes: A Randomized Controlled Trial. Phys Ther. 2018 Sep 1;98(9):745-753. doi: 10.1093/ptj/pzy070.
PubMed 29893977Harish C S, Dixit R, Singh S, Garg S. Sonoelastographic Evaluation of the Achilles Tendon in Patients With Type 2 Diabetes Mellitus. Ultrasound Med Biol. 2020 Nov;46(11):2989-2997. doi: 10.1016/j.ultrasmedbio.2020.07.023. Epub 2020 Aug 18.
PubMed 32819782Hsu PC, Chang KV, Wu WT, Wang JC, Ozcakar L. Effects of Ultrasound-Guided Peritendinous and Intrabursal Corticosteroid Injections on Shoulder Tendon Elasticity: A Post Hoc Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):905-913. doi: 10.1016/j.apmr.2020.11.011. Epub 2020 Dec 15.
PubMed 33338463Rosskopf AB, Ehrmann C, Buck FM, Gerber C, Fluck M, Pfirrmann CW. Quantitative Shear-Wave US Elastography of the Supraspinatus Muscle: Reliability of the Method and Relation to Tendon Integrity and Muscle Quality. Radiology. 2016 Feb;278(2):465-74. doi: 10.1148/radiol.2015150908. Epub 2015 Nov 5.
PubMed 26540450Bamber J, Cosgrove D, Dietrich CF, Fromageau J, Bojunga J, Calliada F, Cantisani V, Correas JM, D'Onofrio M, Drakonaki EE, Fink M, Friedrich-Rust M, Gilja OH, Havre RF, Jenssen C, Klauser AS, Ohlinger R, Saftoiu A, Schaefer F, Sporea I, Piscaglia F. EFSUMB guidelines and recommendations on the clinical use of ultrasound elastography. Part 1: Basic principles and technology. Ultraschall Med. 2013 Apr;34(2):169-84. doi: 10.1055/s-0033-1335205. Epub 2013 Apr 4.
PubMed 23558397Hatta T, Yamamoto N, Sano H, Itoi E. In vivo measurement of rotator cuff tendon strain with ultrasound elastography: an investigation using a porcine model. J Ultrasound Med. 2014 Sep;33(9):1641-6. doi: 10.7863/ultra.33.9.1641.
PubMed 25154947
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07784543
- Acronym / sponsor ID
- PamukkaleU.ftr-AATIGAN-001
- Keywords
- Shoulder Pain, Aerobic Exercise, Supraspinatus Tendinopathy, Type 2 Diabetes Mellitus, Ultrasonography, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation | Active comparator | Behavioral: Conventional Shoulder RehabilitationConventional 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 + Aerobic Exercise | Experimental | Behavioral: Aerobic ExerciseIn 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Shoulder RehabilitationConventional 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. | Behavioural | Conventional Rehabilitation |
| Aerobic ExerciseIn 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. | Behavioural | Conventional Physical Therapy + Aerobic Exercise |
Primary outcome
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.
4 secondary outcomes
Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline (Week 0) and post-treatment (Week 6)
Supraspinatus Tendon Thickness Assessed by Ultrasonography
Time frame: Baseline (Week 0) and post-treatment (Week 6)
Supraspinatus Tendon Stiffness Assessed by Strain Elastography
Time frame: Baseline (Week 0) and post-treatment (Week 6)
Central Sensitization Inventory (CSI)
Time frame: Baseline (Week 0) and post-treatment (Week 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 21951710Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.
- Background: PubMed 31072860Brage K, Hjarbaek J, Kjaer P, Ingwersen KG, Juul-Kristensen B. Ultrasonic strain elastography for detecting abnormalities in the supraspinatus tendon: an intra- and inter-rater reliability study. BMJ Open. 2019 May 9;9(5):e027725. doi: 10.1136/bmjopen-2018-027725.
- Background: PubMed 33458662BaGcier F, Geler KUlcU D, Yorulmaz E, Altunok EC. Intra- and Inter-Rater Reliability of Ultrasound Measurements of Supraspinatus Tendon Thickness, Acromiohumeral Distance, and Occupation Ratio in Patients With Shoulder Impingement Syndrome. Arch Rheumatol. 2020 Feb 7;35(3):385-393. doi: 10.46497/ArchRheumatol.2020.7515. eCollection 2020 Sep.
- Background: PubMed 11188601Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991 Dec;4(4):143-9.
- Background: PubMed 26927584Luque-Suarez A, Rondon-Ramos A, Fernandez-Sanchez M, Roach KE, Morales-Asencio JM. Spanish version of SPADI (shoulder pain and disability index) in musculoskeletal shoulder pain: a new 10-items version after confirmatory factor analysis. Health Qual Life Outcomes. 2016 Mar 1;14:32. doi: 10.1186/s12955-016-0436-4.
- Background: PubMed 27926890Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, Horton ES, Castorino K, Tate DF. Physical Activity/Exercise and Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Nov;39(11):2065-2079. doi: 10.2337/dc16-1728. No abstract available.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alev ATIGAN, Assistant Professor study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Shoulder Rehabilitation and Aerobic Exercise in people with Supraspinatus Tendinopathy and Type 2 Diabetes Mellitus (T2DM), run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melike LALE, MD (+905357822420, melikesalar1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain Assessed by Visual Analog Scale (VAS) (time frame: Baseline (Week 0) and post-treatment (Week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07784543, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.