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NCT Number: NCT05976035

Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain

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.

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Key information

Conditions

Rotator Cuff Syndrome Behavior Motor Activity

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, 34500, Turkey (Türkiye)

Location contact

Derya Çelik, Prof

CONTACT

[email protected]

+905327940169

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

Structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks

Supplement

Other

Receiving supplement that are prescribed by a orthopedist every day for 8 weeks

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: change from baseline pain at 12 weeks

    The scale has range 0 to 10mm. The left side (0mm) shows no pain, and the right side (10mm) shows the most severe pain imaginable. Patients will be asked to mark the severity of their shoulder pain at a point on the scale using this scale. Higher points indicate higher severity and lower points indicate lower severity.

  2. The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)

    Time frame: change from baseline pain at 12 weeks

    Among the self-assessment of the patients, there are 11 items including pain level and functionality. For pain in scoring, they describe pain of increasing severity between 0 and 10; In functionality, a 4-point Likert-type scale is used to determine whether they can perform activities of daily living or not. The total score ranges from 0 (absence of function) to 100 (normal function).

  3. Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH)

    Time frame: change from baseline pain at 12 weeks

    Quick DASH is an 11-item questionnaire used to assess upper extremity functionality. The score ranges from 0 (no injury) to 100 (most severe injury).

Secondary outcomes

  1. Rotator Cuff Quality of Life (RC-QoL)

    Time frame: 3 times for 12 weeks

    It is a self-assessment questionnaire consisting of a total of 34 questions and 5 sections assessing the disease-specific quality of life. Each question is assessed on a 100 mm visual analog scale, with 0 representing the lowest score and 100 the best score, and the total score is given as a percentage. Low scores represent low quality of life.

  2. Global Rating of Change Scale (GRC)

    Time frame: 3 times for 12 weeks

    It is a scale to evaluate patient satisfaction. It is designed to determine the extent to which the patient improves or worsens over time. In our study, the change between the pre-treatment status of the participants and their current status at the 8th and 12th weeks after the treatment will be questioned. In our study, GRC consisting of 5 levels between -2 and +2 value ranges (-2: I am much worse, -1: I am worse, 0: I am the same, 1: I am better, 2: I am much better) will be preferred.

Study contacts

Contact information is provided by the study sponsor or research team.

Derya Çelik, Prof

CONTACT

[email protected]

+905327940169

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2023
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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