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Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain

Primary Purpose

Rotator Cuff Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Supplement
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Syndrome focused on measuring Exercise, Physical Therapy, Anti-oxidant, Anti-Inflammatory

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Exercise & Supplement Group

Exercise Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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).
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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 27, 2023
Last Updated
August 8, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05976035
Brief Title
Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain
Official Title
Do Taking Supplements Provide Additional Benefits in Rotator Cuff-Related Shoulder Pain?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Syndrome
Keywords
Exercise, Physical Therapy, Anti-oxidant, Anti-Inflammatory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be divided into two groups with equal numbers by computer randomization method.
Masking
Outcomes Assessor
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.
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise & Supplement Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
Exercise group will follow a structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks
Intervention Type
Other
Intervention Name(s)
Supplement
Intervention Description
Receiving supplement that are prescribed by a orthopedist every day for 8 weeks
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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 weeks
Title
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)
Description
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 weeks
Title
Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH)
Description
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 weeks
Secondary Outcome Measure Information:
Title
Rotator Cuff Quality of Life (RC-QoL)
Description
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 weeks
Title
Global Rating of Change Scale (GRC)
Description
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 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Derya Çelik, Prof
Phone
+905327940169
Email
derya.celik@iuc.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derya Çelik, Prof.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpaşa
City
Istanbul
ZIP/Postal Code
34500
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derya Çelik, Prof
Phone
+905327940169
Email
derya.celik@iuc.edu.tr

12. IPD Sharing Statement

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26390274
Citation
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Citation
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Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain

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