Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain
ConditionRotator Cuff Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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°,
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Other interventionStructured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks
Supplement
Other interventionReceiving supplement that are prescribed by a orthopedist every day for 8 weeks
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Exercise & Supplement GroupActive comparator 2 interventions
Group B: Exercise GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analog Scale (VAS)
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.
Time frame
change from baseline pain at 12 weeks2
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)
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).
Time frame
change from baseline pain at 12 weeks3
Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH)
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).
Time frame
change from baseline pain at 12 weeksSecondary outcomes
1
Rotator Cuff Quality of Life (RC-QoL)
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.
Time frame
3 times for 12 weeks2
Global Rating of Change Scale (GRC)
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.
Time frame
3 times for 12 weeksSponsors and contacts
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Source ClinicalTrials.gov
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