Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain

NCT05976035 | Not Yet Recruiting

• 1 other identifier: A-3456789876
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Syndrome

Keywords

Exercise; Physical Therapy; Anti-oxidant; Anti-Inflammatory

Outcome Measures

Primary Outcomes (3)

• 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.

  change from baseline pain at 12 weeks

• 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).

  change from baseline pain at 12 weeks

• 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).

  change from baseline pain at 12 weeks

Secondary Outcomes (2)

• Rotator Cuff Quality of Life (RC-QoL)

  3 times for 12 weeks

• Global Rating of Change Scale (GRC)

  3 times for 12 weeks

Study Arms (2)

Exercise & Supplement Group

ACTIVE COMPARATOR

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.

Other: Exercise; Other: Supplement

Exercise Group

ACTIVE COMPARATOR

Exercise group will follow a structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks.

Other: Exercise

Interventions

Exercise OTHER

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

Exercise & Supplement Group; Exercise Group

Supplement OTHER

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

Exercise & Supplement Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

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

Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (16)

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  PMID: 26390274 BACKGROUND

• Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.

  PMID: 15163107 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 BACKGROUND

• Celik D, Atalar AC, Demirhan M, Dirican A. Translation, cultural adaptation, validity and reliability of the Turkish ASES questionnaire. Knee Surg Sports Traumatol Arthrosc. 2013 Sep;21(9):2184-9. doi: 10.1007/s00167-012-2183-3. Epub 2012 Aug 30.

  PMID: 22932692 BACKGROUND

• Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.

  PMID: 15866967 BACKGROUND

• Cinar-Medeni O, Ozengin N, Baltaci G, Duzgun I. Turkish version of the Rotator Cuff Quality of Life questionnaire in rotator cuff-impaired patients. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):591-5. doi: 10.1007/s00167-014-3290-0. Epub 2014 Sep 11.

  PMID: 25209207 BACKGROUND

• Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.

  PMID: 20046623 BACKGROUND

• Matthews TJ, Hand GC, Rees JL, Athanasou NA, Carr AJ. Pathology of the torn rotator cuff tendon. Reduction in potential for repair as tear size increases. J Bone Joint Surg Br. 2006 Apr;88(4):489-95. doi: 10.1302/0301-620X.88B4.16845.

  PMID: 16567784 BACKGROUND

• Millar NL, Hueber AJ, Reilly JH, Xu Y, Fazzi UG, Murrell GA, McInnes IB. Inflammation is present in early human tendinopathy. Am J Sports Med. 2010 Oct;38(10):2085-91. doi: 10.1177/0363546510372613. Epub 2010 Jul 1.

  PMID: 20595553 BACKGROUND

• Andersson G, Backman LJ, Scott A, Lorentzon R, Forsgren S, Danielson P. Substance P accelerates hypercellularity and angiogenesis in tendon tissue and enhances paratendinitis in response to Achilles tendon overuse in a tendinopathy model. Br J Sports Med. 2011 Oct;45(13):1017-22. doi: 10.1136/bjsm.2010.082750. Epub 2011 May 2.

  PMID: 21540192 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Dietary Supplements

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Derya Çelik, Prof.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Derya Çelik, Prof

CONTACT

+905327940169; derya.celik@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be divided into two groups with equal numbers by computer randomization method.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

TU (1)