Effect of Adding Extracorporeal Shock Wave Therapy to Exercises in Rotator Cuff Tendinopathy

Официальное название

Effect of Adding Extracorporeal Shock Wave Therapy to Exercises in Rotator Cuff Tendinopathy: A Randomized Controlled Trial

Обзор

Rotator cuff tendinopathy (RCT) is one of the most common causes of shoulder pain, resulting in functional limitations and reduced quality of life. Exercise therapy is considered a first-line treatment; however, adjunct modalities such as extracorporeal shock wave therapy (ESWT) may enhance recovery. This study aims to evaluate the effect of adding ESWT to a rotator cuff and scapular stabilization exercise program in patients with rotator cuff tendinopathy.

Подробное описание

Rotator cuff tendinopathy involves chronic overload and microtrauma of the rotator cuff tendons, leading to pain, inflammation, and functional impairment. Therapeutic exercises that target the rotator cuff and scapular stabilizers are commonly prescribed to restore muscle control and shoulder kinematics.

Extracorporeal shock wave therapy (ESWT) has demonstrated potential for tendon regeneration, pain reduction, and improved vascularization. This randomized controlled trial investigates whether the combination of ESWT and exercise therapy produces greater improvements than exercise therapy alone in reducing supraspinatus tendon thickness and pain and improving shoulder function.

Fifty participants aged 30-55 years with confirmed RCT will be randomly assigned into two groups:

* Group A (Experimental): ESWT + rotator cuff and scapular stabilization exercises. * Group B (Active Comparator): Rotator cuff and scapular stabilization exercises only.

Both groups will be treated for 6 weeks, with 3 exercise sessions per week; Group A will receive 1 ESWT session weekly in addition to exercises.

Вмешательства

• Другое Extracorporeal Shock Wave Therapy (ESWT) with Exercise
  Focused extracorporeal shock wave therapy (ESWT) will be applied to the supraspinatus tendon at 1.5 bar, 1500 shocks per session, once weekly for 6 weeks, in combination with a rotator cuff and scapular stabilization exercise program performed three times weekly. This combination is designed to promote tendon healing, improve strength, and reduce shoulder pain.
• Другое Exercise Therapy
  A standardized rotator cuff and scapular stabilization exercise program including strengthening, stretching, and control training for the shoulder complex. Exercises are performed three times weekly for 6 weeks under supervision. This program serves as the active control for comparison with ESWT + Exercise.

Первичные конечные точки

• Change in Supraspinatus Tendon Thickness [Срок оценки: Baseline and at 6 weeks post-intervention]
• Change in Shoulder Pain Intensity (Numeric Pain Rating Scale, NPRS) [Срок оценки: Baseline and at 6 weeks post-intervention]
• Change in Shoulder Disability (Shoulder Pain and Disability Index, SPADI) [Срок оценки: Baseline and at 6 weeks post-intervention]
• Change in Isometric Shoulder Muscle Strength [Срок оценки: Baseline and at 6 weeks post-intervention]

Критерии участия

Критерии включения

• Medically stable individuals who consent to participate in the study.
• Male and female participants aged between 30 and 55 years.
• Diagnosed with rotator cuff tendinopathy, confirmed clinically and by ultrasound or MRI.
• Duration of symptoms greater than 3 months.
• Supraspinatus tendon thickness > 5.85 mm as measured by ultrasound (based on Hunter et al., 2021).
• Able to follow the treatment plan and attend all therapy sessions.

Критерии исключения

• Massive rotator cuff tear or complete tendon rupture.
• Adhesive capsulitis or significant limitation of passive shoulder motion.
• History of shoulder fracture, dislocation, or surgery in the affected limb.
• Rheumatoid arthritis, diabetes mellitus, or systemic inflammatory disease.
• Cervical radiculopathy or neurological involvement affecting the shoulder.
• Corticosteroid injection in the affected shoulder within the last 6 months.
• Pregnancy or breastfeeding.
• BMI > 30 kg/m² (obese individuals excluded).
• Current malignancy, open wounds, or local infection at the treatment site.
• Inability to tolerate shock wave therapy or perform exercise sessions.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• faculty of physical therapy, Deraya University — Minya

Публикации

• Michener LA, Subasi Yesilyaprak SS, Seitz AL, Timmons MK, Walsworth MK. Supraspinatus tendon and subacromial space parameters measured on ultrasonographic imaging in subacromial impingement syndrome. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):363-9. doi: 10.1007/s00167-013-2542-8. Epub 2013 Jun 5. PMID 23736252
• Lyng KD, Andersen JD, Jensen SL, Olesen JL, Arendt-Nielsen L, Madsen NK, Petersen KK. The influence of exercise on clinical pain and pain mechanisms in patients with subacromial pain syndrome. Eur J Pain. 2022 Oct;26(9):1882-1895. doi: 10.1002/ejp.2010. Epub 2022 Jul 27. PMID 35852027
• Liaghat B, Skou ST, Jorgensen U, Sondergaard J, Sogaard K, Juul-Kristensen B. Heavy shoulder strengthening exercise in people with hypermobility spectrum disorder (HSD) and long-lasting shoulder symptoms: a feasibility study. Pilot Feasibility Stud. 2020 Jul 10;6:97. doi: 10.1186/s40814-020-00632-y. eCollection 2020. PMID 32670599
• Fournier Belley A, Gagnon DH, Routhier F, Roy JS. Ultrasonographic Measures of the Acromiohumeral Distance and Supraspinatus Tendon Thickness in Manual Wheelchair Users With Spinal Cord Injury. Arch Phys Med Rehabil. 2017 Mar;98(3):517-524. doi: 10.1016/j.apmr.2016.06.018. Epub 2016 Jul 16. PMID 27431359
• Beshay, N., Lam, P. H., & Murrell, G. A. C. (2011). Assessing the Reliability of Shoulder Strength Measurement: Hand-Held versus Fixed Dynamometry. Shoulder & Elbow, 3(4), 244-251. https://doi.org/10.1111/j.1758-5740.2011.00137.x
• Fraenkel L, Falzer P, Fried T, Kohler M, Peters E, Kerns R, Leventhal H. Measuring pain impact versus pain severity using a numeric rating scale. J Gen Intern Med. 2012 May;27(5):555-60. doi: 10.1007/s11606-011-1926-z. Epub 2011 Nov 12. PMID 22081365
• Alsanawi HA, Alghadir A, Anwer S, Roach KE, Alawaji A. Cross-cultural adaptation and psychometric properties of an Arabic version of the Shoulder Pain and Disability Index. Int J Rehabil Res. 2015 Sep;38(3):270-5. doi: 10.1097/MRR.0000000000000118. PMID 25954858
• Breckenridge JD, McAuley JH. Shoulder Pain and Disability Index (SPADI). J Physiother. 2011;57(3):197. doi: 10.1016/S1836-9553(11)70045-5. PMID 21843839

Идентификаторы

NCT: NCT07390396 · DU-PT-ESWT-RCT-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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