ClinicalTrials.Veeva

Menu

Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain

I

Istanbul University - Cerrahpasa (IUC)

Status

Not yet enrolling

Conditions

Rotator Cuff Syndrome

Treatments

Other: Exercise
Other: Supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT05976035
A-3456789876

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

58 participants in 2 patient groups

Exercise & Supplement Group
Active Comparator group
Description:
Exercise \& Supplement group will take supplements that are prescribed by the orthopedist every day for 8 weeks in addition to a structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks.
Treatment:
Other: Supplement
Other: Exercise
Exercise Group
Active Comparator group
Description:
Exercise group will follow a structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks.
Treatment:
Other: Exercise

Trial contacts and locations

1

Loading...

Central trial contact

Derya Çelik, Prof

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems