Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain

Официальное название

Do Taking Supplements Provide Additional Benefits in Rotator Cuff-Related Shoulder Pain?

Обзор

Rotator cuff-related shoulder pain is a pathology characterized by pain and functional impairment originating from one or more rotator cuff tendons. The lifetime incidence of rotator cuff-related shoulder pain is around 67%, with an annual incidence exceeding 1%. Many patients continue to experience pain and functional loss for up to one year, and more than half of the patients report shoulder pain persisting for over three years. The pathophysiology underlying rotator cuff-related shoulder pain continues to be a subject of ongoing research and uncertainty, with many aspects yet to be fully elucidated. The most common belief regarding its pathogenesis involves the role of inflammation. This hypothesis is supported by the accumulation of inflammatory cells in tendons, oxidative stress, and increased levels of pro-inflammatory cytokines. In tendon pathologies with inflammatory cell accumulation and increased cytokine levels, the use of antioxidants and anti-inflammatory agents in addition to conservative treatment contributes to tendon healing. Anti-oxidants and anti-inflammatories are substances capable of preventing or delaying certain cell damage.The use of anti-inflammatory and antioxidant supplements such as Vitamin C (Vit-C), Vitamin D (Vit-D), Omega-3, and Magnesium (Mg) is recommended. Despite indicating exercise as the gold standard for managing rotator cuff-related shoulder pain and the demonstrated anti-inflammatory and anti-oxidant properties of the mentioned supplements, there are still gaps in the understanding of their effectiveness in rotator cuff-related shoulder pain. Based on these gaps, the goal of this study is to investigate the effects of supplements (Vit-C, Vit-D, Omega-3, and Mg) given in addition to exercise on patients' blood parameters (TNF-a, IL-6, and CRP levels), pain, functional status, quality of life, and patient satisfaction in individuals with rotator cuff-related shoulder pain.

Подробное описание

58 participants older than 40 years of age with rotator cuff-related shoulder pain for at least 3 months will be included in the study. Signed voluntary consent will be obtained from the patients. Participants will be divided into two groups. Study groups will be as follows: a) Exercise \& Supplement Group and b) Exercise Group.

Вмешательства

• Другое Exercise
  Structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks
• Другое Supplement
  Receiving supplement that are prescribed by a orthopedist every day for 8 weeks

Первичные конечные точки

• Visual Analog Scale (VAS) [Срок оценки: change from baseline pain at 12 weeks]
• The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES) [Срок оценки: change from baseline pain at 12 weeks]
• Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH) [Срок оценки: change from baseline pain at 12 weeks]

Вторичные конечные точки (2)

• Rotator Cuff Quality of Life (RC-QoL) [Срок оценки: 3 times for 12 weeks]
• Global Rating of Change Scale (GRC) [Срок оценки: 3 times for 12 weeks]

Критерии участия

Критерии включения

• Being over the age of 40
• Diagnosing with rotator cuff-related shoulder pain confirming through clinical examination (Hawkins Kennedy and Empty Can tests) and MRI imaging
• Having shoulder pain for at least three months

Критерии исключения

• Having full-thickness or massive rotator cuff tear,
• Having a history of symptoms onset due to trauma,
• Having a history of surgery on the same shoulder,
• Having shoulder passive external rotation <30° and flexion <120°,
• Having shoulder instability,
• Having an allergy to any supplement,
• Having psychological, emotional, or cognitive problems
• Presence of shoulder problems caused by systemic diseases,
• Presence of diabetes, presence of pregnancy or breastfeeding,
• Malignancy.

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

Turkey (Türkiye) · 1 центр

• Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Istanbul Un — Istanbul

Публикации

• Lewis J, McCreesh K, Roy JS, Ginn K. Rotator Cuff Tendinopathy: Navigating the Diagnosis-Management Conundrum. J Orthop Sports Phys Ther. 2015 Nov;45(11):923-37. doi: 10.2519/jospt.2015.5941. Epub 2015 Sep 21. PMID 26390274
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• Tashjian RZ. Epidemiology, natural history, and indications for treatment of rotator cuff tears. Clin Sports Med. 2012 Oct;31(4):589-604. doi: 10.1016/j.csm.2012.07.001. Epub 2012 Aug 30. PMID 23040548
• Macfarlane GJ, Hunt IM, Silman AJ. Predictors of chronic shoulder pain: a population based prospective study. J Rheumatol. 1998 Aug;25(8):1612-5. PMID 9712108
• Litchfield R. Progressive strengthening exercises for subacromial impingement syndrome. Clin J Sport Med. 2013 Jan;23(1):86-7. doi: 10.1097/JSM.0b013e31827e9fb5. PMID 23269329
• Vaysman M, Alben M, Todd M, Ruotolo C. Pharmacologic Enhancement of Rotator Cuff Repair: A Narrative Review. Orthop Rev (Pavia). 2022 Sep 4;14(3):37782. doi: 10.52965/001c.37782. eCollection 2022. PMID 36072503
• Yuan T, Qian H, Yu X, Meng J, Lai CT, Jiang H, Zhao JN, Bao NR. Proteomic analysis reveals rotator cuff injury caused by oxidative stress. Ther Adv Chronic Dis. 2021 Mar 17;12:2040622320987057. doi: 10.1177/2040622320987057. eCollection 2021. PMID 33796243
• Metsios GS, Moe RH, Kitas GD. Exercise and inflammation. Best Pract Res Clin Rheumatol. 2020 Apr;34(2):101504. doi: 10.1016/j.berh.2020.101504. Epub 2020 Apr 2. PMID 32249021

Идентификаторы

NCT: NCT05976035 · A-3456789876

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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