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Does Physical Activity Provide Additional Benefit In Patients With Rotator Cuff Related Shoulder Pain?

Primary Purpose

Rotator Cuff Injuries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise program consisting of supervised exercise and physical activity
exercise program consisting of only supervised exercises.
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries focused on measuring rotator cuff, physical activity, shoulder pain

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject age of more than 40 years Having at least 3 months of unilateral shoulder pain Presence of painful arc Positive Hawkins Kennedy test or positive Neer sign Painful shoulder abduction and external rotation with resistance Absence of radiological findings of fracture in the humeral greater tubercle or glenoid cavity Obtaining informed written consent Exclusion Criteria: Having a massive rotator cuff tear (confirmed with Magnetic Resonance (MR) and positive lag sign) History of trauma related to onset of symptoms Having undergone surgery on the same shoulder Frozen shoulder Symptomatic cervical spine pathology Shoulder instability Presence of shoulder problems caused by systemic diseases, neurological disorders Having psychological, emotional or cognitive problems Previous shoulder surgery and steroid injections Engagement of regular physical activity

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical Activity Group

Control Group

Arm Description

The Physical Activity (PAG) was included in an exercise program consisting of supervised exercise and physical activity (30 minutes of moderate-intensity walking).

The Control Group (CG) was included in the program consisting of only supervised exercises.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
The pain will be measured at activity and at night using a NPRS. Patients are asked to rate their pain ranging from 0 to 10 (0: no pain, 10: the worst pain imaginable)
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)
The ASES score ranges from 0-100. Higher scores indicate better functional ability.
Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH)
The Quick DASH is a 11-item questionnaire used to assess upper limb functionality. The score ranges from 0 (no disability) to 100 (most severe disability).

Secondary Outcome Measures

Global Rate of Changes (GRC)
GRC is used to determine the effectiveness of treatment by questioning the patient's improvement or worsening over time. In our study, a 7-point scale (-3: much worse, -2: worse, -1: slightly worse, 0: same, 1: slightly better, 2: quite good, 3: much better) was used.
Rotator Cuff Quality of Life (RC-QOL)
RC-QOL consists of 34 items and each question consists of a line between 0 and 100. The point on the line is measured with a ruler and the value is written. Higher values indicate better quality of life.The total score ranges from 0 to 3400, with higher scores indicating higher quality of life. The percentage (%) score can also be calculated by dividing the total score obtained by 34.
Western-Ontario Rotator Cuff Index (WORC)
WORC-Emotions consist of 3 items. Each question is answered with a 100 mm Visual Analog Scale (VAS). Lower scores indicate better quality of life motions consist of 3 items. Each question is answered with a 100 mm Visual Analog Scale (VAS). Lower scores indicate better quality of life.The total score ranges from 0 to 300, with lower scores indicating higher quality of life. The percentage (%) score can also be calculated by dividing the total score obtained by 3.

Full Information

First Posted
March 16, 2023
Last Updated
September 2, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05821283
Brief Title
Does Physical Activity Provide Additional Benefit In Patients With Rotator Cuff Related Shoulder Pain?
Official Title
Does Physical Activity Provide Additional Benefit In Patients With Rotator Cuff Related Shoulder Pain? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
August 20, 2023 (Actual)
Study Completion Date
August 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

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

5. Study Description

Brief Summary
Rotator cuff-related shoulder pain (RCRSP) are among the most common musculoskeletal disorders and can be associated with pain, weakness, shoulder dysfunction and kinesiophobia. The management could be surgery or nonsurgical options such as medical treatment, education, activity modifications and physiotherapy. Physical activity is defined as any body movement produced by skeletal muscles that requires a certain amount of energy expenditure. Regular physical activity is proven to help prevent and manage many diseases. Beyond these people, doing physical activity have better mental health, emotional wellbeing, quality of life and lower rates of mental illness. Additionally, physical activity and exercise applications are used as an alternative method to reduce the severity and frequency of pain in patients with chronic pain. Investigators reviewed the literature, we could not find any randomized controlled trial on the effectiveness of physical activity in studies conducted with patients with RCRSP. Investigators hypothesized that adding physical activity to the treatment of RCRSP would make a significant difference. Therefore, the aim of this study was to investigate the effect of physical activity applied in addition to supervised exercise on pain, functional status and quality of life in patients with RCRSP.
Detailed Description
Rotator cuff-related shoulder pain (RCRSP) are among the most common musculoskeletal disorders and can be associated with pain, weakness, shoulder dysfunction and kinesiophobia. The management could be surgery or nonsurgical options such as medical treatment, education, activity modifications and physiotherapy. However, none of this interventions was found best additionally 30% of individuals do not report significant improvement. Physical activity is defined as any body movement produced by skeletal muscles that requires a certain amount of energy expenditure. Regular physical activity is proven to help prevent and manage many diseases such as heart disease, stroke, several cancers, diabetes, hypertension and obesity. Beyond these people, doing physical activity have better mental health, emotional wellbeing, quality of life and lower rates of mental illness. Additionally, physical activity and exercise applications are used as an alternative method to reduce the severity and frequency of pain in patients with chronic pain. Physical activity is defined as any body movement produced by skeletal muscles that requires a certain amount of energy expenditure. Investigators reviewed the literature, investigators could not find any randomized controlled trial on the effectiveness of physical activity in studies conducted with patients with RCRSP. Investigators hypothesized that adding physical activity to the treatment of RCRSP would make a significant difference. Therefore, the aim of this study was to investigate the effect of physical activity applied in addition to supervised exercise on pain, functional status and quality of life in patients with RCRSP. This study was prospective, randomized controlled; assessor-blinded trial was performed to compare the effectiveness of physical activity in addition to supervised exercise in patients with RCRSP. According to the power analysis result, 46 patients were randomized into two groups(Treatment Group=23, Control Group=23).The Physical Activity Group (PAG) was included in an exercise program consisting of supervised exercise and physical activity (30 minutes of moderate-intensity walking). The Control Group (CG) was included in the program consisting of supervised exercises only. The treatment lasted for a total of 6 weeks. The primary outcomes were Numeric Pain Rating Scale (NPRS), The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES), Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH) and secondary outcomes were Rotator Cuff Quality of Life (RC-QOL) Western-Ontario Rotator Cuff Index (WORC) and Global Rate of Changes (GRC) scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries
Keywords
rotator cuff, physical activity, shoulder pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity Group
Arm Type
Experimental
Arm Description
The Physical Activity (PAG) was included in an exercise program consisting of supervised exercise and physical activity (30 minutes of moderate-intensity walking).
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The Control Group (CG) was included in the program consisting of only supervised exercises.
Intervention Type
Procedure
Intervention Name(s)
exercise program consisting of supervised exercise and physical activity
Intervention Description
The Physical Activity Group (PAG) included in an exercise program consisting of supervised exercise and physical activity (30 minutes of moderate-intensity walking). Patients received 6 week (2-3 times a week) rehabilitation program composed of 15 physical therapy sessions.The physical activity program was applied as moderate intensity (maximum heart rate 50-70%) walking exercise. The patients were recommended to walk for 30 minutes, 3 days a week (total of 90 minutes) for the first 3 weeks, and 30 minutes 5 days a week (total of 150 minutes) for the 2nd 3 weeks
Intervention Type
Procedure
Intervention Name(s)
exercise program consisting of only supervised exercises.
Intervention Description
The Control Group (CG) included in the program consisting of only supervised exercises. Patients received 6 week (2-3 times a week) rehabilitation program composed of 15 physical therapy sessions
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
The pain will be measured at activity and at night using a NPRS. Patients are asked to rate their pain ranging from 0 to 10 (0: no pain, 10: the worst pain imaginable)
Time Frame
change from baseline NPRS at 6 week
Title
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)
Description
The ASES score ranges from 0-100. Higher scores indicate better functional ability.
Time Frame
change from baseline ASES score at 6 week
Title
Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH)
Description
The Quick DASH is a 11-item questionnaire used to assess upper limb functionality. The score ranges from 0 (no disability) to 100 (most severe disability).
Time Frame
change from baseline Quick DASH score at 6 week
Secondary Outcome Measure Information:
Title
Global Rate of Changes (GRC)
Description
GRC is used to determine the effectiveness of treatment by questioning the patient's improvement or worsening over time. In our study, a 7-point scale (-3: much worse, -2: worse, -1: slightly worse, 0: same, 1: slightly better, 2: quite good, 3: much better) was used.
Time Frame
change from baseline GRC score at 6 week
Title
Rotator Cuff Quality of Life (RC-QOL)
Description
RC-QOL consists of 34 items and each question consists of a line between 0 and 100. The point on the line is measured with a ruler and the value is written. Higher values indicate better quality of life.The total score ranges from 0 to 3400, with higher scores indicating higher quality of life. The percentage (%) score can also be calculated by dividing the total score obtained by 34.
Time Frame
change from baseline RC-QOL score at 6 week
Title
Western-Ontario Rotator Cuff Index (WORC)
Description
WORC-Emotions consist of 3 items. Each question is answered with a 100 mm Visual Analog Scale (VAS). Lower scores indicate better quality of life motions consist of 3 items. Each question is answered with a 100 mm Visual Analog Scale (VAS). Lower scores indicate better quality of life.The total score ranges from 0 to 300, with lower scores indicating higher quality of life. The percentage (%) score can also be calculated by dividing the total score obtained by 3.
Time Frame
change from baseline WORC score at 6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject age of more than 40 years Having at least 3 months of unilateral shoulder pain Presence of painful arc Positive Hawkins Kennedy test or positive Neer sign Painful shoulder abduction and external rotation with resistance Absence of radiological findings of fracture in the humeral greater tubercle or glenoid cavity Obtaining informed written consent Exclusion Criteria: Having a massive rotator cuff tear (confirmed with Magnetic Resonance (MR) and positive lag sign) History of trauma related to onset of symptoms Having undergone surgery on the same shoulder Frozen shoulder Symptomatic cervical spine pathology Shoulder instability Presence of shoulder problems caused by systemic diseases, neurological disorders Having psychological, emotional or cognitive problems Previous shoulder surgery and steroid injections Engagement of regular physical activity
Facility Information:
Facility Name
Istanbul University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Does Physical Activity Provide Additional Benefit In Patients With Rotator Cuff Related Shoulder Pain?

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