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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Melike LALE, MD
- 전화번호: +905357822420
- 이메일: melikesalar1@gmail.com
연구 장소
-
-
-
Denizli, 터키 (Türkiye)
- Pamukkale University, Denizli
-
연락하다:
- Melike LALE, MD
- 전화번호: +905357822420
- 이메일: melikesalar1@gmail.com
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Shoulder Pain Assessed by Visual Analog Scale (VAS)
기간: 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.
|
Baseline (Week 0) and post-treatment (Week 6)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index (SPADI)
기간: 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.
|
Baseline (Week 0) and post-treatment (Week 6)
|
|
Supraspinatus Tendon Thickness Assessed by Ultrasonography
기간: 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.
|
Baseline (Week 0) and post-treatment (Week 6)
|
|
Supraspinatus Tendon Stiffness Assessed by Strain Elastography
기간: 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.
|
Baseline (Week 0) and post-treatment (Week 6)
|
|
Central Sensitization Inventory (CSI)
기간: 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.
|
Baseline (Week 0) and post-treatment (Week 6)
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Alev ATIGAN, Assistant Professor, Pamukkale University
간행물 및 유용한 링크
일반 간행물
- 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.
- Roach 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.
- Bamber 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.
- Hsu CL, Sheu WH. Diabetes and shoulder disorders. J Diabetes Investig. 2016 Sep;7(5):649-51. doi: 10.1111/jdi.12491. Epub 2016 Mar 16. No abstract available.
- Steuri 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.
- Colberg 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.
- Cade WT. Diabetes-related microvascular and macrovascular diseases in the physical therapy setting. Phys Ther. 2008 Nov;88(11):1322-35. doi: 10.2522/ptj.20080008. Epub 2008 Sep 18.
- Rosskopf 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.
- Manders RJ, Van Dijk JW, van Loon LJ. Low-intensity exercise reduces the prevalence of hyperglycemia in type 2 diabetes. Med Sci Sports Exerc. 2010 Feb;42(2):219-25. doi: 10.1249/MSS.0b013e3181b3b16d.
- NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet. 2016 Apr 9;387(10027):1513-1530. doi: 10.1016/S0140-6736(16)00618-8. Epub 2016 Apr 6.
- Brage 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.
- BaGcier 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.
- Luque-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.
- ElSayed 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.
- Yang 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.
- Mueller 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.
- Harish 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.
- Hsu 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.
- Hatta 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.
- Wu WT, Chen LR, Chang HC, Chang KV, Ozcakar L. Quantitative Ultrasonographic Analysis of Changes of the Suprascapular Nerve in the Aging Population With Shoulder Pain. Front Bioeng Biotechnol. 2021 Feb 19;9:640747. doi: 10.3389/fbioe.2021.640747. eCollection 2021.
- Barad HV, Patel V, Patel S, Patel M. To determine the role of ultrasonography as a primary imaging modality as compared to MRI in patients with shoulder pain. J Family Med Prim Care. 2022 May;11(5):2119-2122. doi: 10.4103/jfmpc.jfmpc_2509_20. Epub 2022 May 14.
- Ward H, Jawad AS. Musculoskeletal manifestations of diabetes mellitus - an update. Clin Med (Lond). 2026 Jan;26(1):100498. doi: 10.1016/j.clinme.2025.100498. Epub 2025 Aug 10.
- Cole A, Gill TK, Shanahan EM, Phillips P, Taylor AW, Hill CL. Is diabetes associated with shoulder pain or stiffness? Results from a population based study. J Rheumatol. 2009 Feb;36(2):371-7. doi: 10.3899/jrheum.080349.
- Sheikh RK, Toseef A, Omer A, Aftab A, Haider Khan MM, Ayaz SB, Althomli O, Razzaq A, Khokhar S, Jabbar N, Awan WA. Effects of moderate physical activity on diabetic adhesive capsulitis: a randomized clinical trial. PeerJ. 2024 Sep 18;12:e18030. doi: 10.7717/peerj.18030. eCollection 2024.
- Borror A, Zieff G, Battaglini C, Stoner L. The Effects of Postprandial Exercise on Glucose Control in Individuals with Type 2 Diabetes: A Systematic Review. Sports Med. 2018 Jun;48(6):1479-1491. doi: 10.1007/s40279-018-0864-x.
- Arkkila PE, Gautier JF. Musculoskeletal disorders in diabetes mellitus: an update. Best Pract Res Clin Rheumatol. 2003 Dec;17(6):945-70. doi: 10.1016/j.berh.2003.11.001.
- Abate M, Schiavone C, Salini V, Andia I. Management of limited joint mobility in diabetic patients. Diabetes Metab Syndr Obes. 2013 May 7;6:197-207. doi: 10.2147/DMSO.S33943. Print 2013.
- Shah KM, Ruth Clark B, McGill JB, Lang CE, Mueller MJ. Shoulder limited joint mobility in people with diabetes mellitus. Clin Biomech (Bristol). 2015 Mar;30(3):308-13. doi: 10.1016/j.clinbiomech.2014.12.013. Epub 2015 Jan 6.
- Mendes ES, Horvath G, Campos M, Wanner A. Rapid corticosteroid effect on beta(2)-adrenergic airway and airway vascular reactivity in patients with mild asthma. J Allergy Clin Immunol. 2008 Mar;121(3):700-4. doi: 10.1016/j.jaci.2007.10.038. Epub 2007 Dec 20.
- Douloumpakas I, Pyrpasopoulou A, Triantafyllou A, Sampanis Ch, Aslanidis S. Prevalence of musculoskeletal disorders in patients with type 2 diabetes mellitus: a pilot study. Hippokratia. 2007 Oct;11(4):216-8.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- PamukkaleU.ftr-AATIGAN-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .