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NCT05976035 | NOT YET RECRUITING | Rotator Cuff Syndrome


Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain
Sponsor:

Istanbul University - Cerrahpasa

Information provided by (Responsible Party):

Aysenar Erek

Brief Summary:

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.

Condition or disease

Rotator Cuff Syndrome

Intervention/treatment

Exercise

Supplement

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 58 participants
Masking : SINGLE
Masking Description : The investigator administering the treatment and the investigator performing the assessment will be different. The assessor will not know about the interventions that the participants received.
Primary Purpose : TREATMENT
Official Title : Do Taking Supplements Provide Additional Benefits in Rotator Cuff-Related Shoulder Pain?
Actual Study Start Date : 2025-10-01
Estimated Primary Completion Date : 2026-10-01
Estimated Study Completion Date : 2026-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
Exclusion Criteria
  • * 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.

Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain

Location Details

NCT05976035


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Locations


Not yet recruiting

Turkey,

Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpaşa

Istanbul, Turkey, 34500

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