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

NCT ID: NCT05821283

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-08-25

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 outcome was Numeric Pain Rating Scale (NPRS)-activity and secondary outcomes were Numeric Pain Rating Scale (NPRS)-night The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES), Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH), Rotator Cuff Quality of Life (RC-QOL) Western-Ontario Rotator Cuff Index (WORC) and Global Rate of Changes (GRC) scores.

Conditions

Rotator Cuff Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physical Activity Group

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

Group Type: EXPERIMENTAL

exercise program consisting of supervised exercise and physical activity

Intervention Type: PROCEDURE

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

Control Group

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

Group Type: ACTIVE_COMPARATOR

exercise program consisting of only supervised exercises.

Intervention Type: PROCEDURE

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

Interventions

exercise program consisting of supervised exercise and physical activity

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

exercise program consisting of only supervised exercises.

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Derya Celik

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DR2023

Identifier Type: -

Identifier Source: org_study_id