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

NCT05821283 | Completed

• 1 other identifier: DR2023
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Injuries

Keywords

rotator cuff; physical activity; shoulder pain

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)-activity

  The pain will be measured at activity using a NPRS. Patients are asked to rate their pain ranging from 0 to 10 (0: no pain, 10: the worst pain imaginable)

  change from baseline NPRS at 6 week

Secondary Outcomes (6)

• Numeric Pain Rating Scale (NPRS)-night

  change from baseline NPRS at 6 week

• The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)

  change from baseline ASES score at 6 week

• Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH)

  change from baseline Quick DASH score at 6 week

• Rotator Cuff Quality of Life (RC-QOL)

  change from baseline RC-QOL score at 6 week

• Western-Ontario Rotator Cuff Index (WORC)

  change from baseline WORC score at 6 week

Study Arms (2)

Physical Activity Group

EXPERIMENTAL

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

Procedure: exercise program consisting of supervised exercise and physical activity

Control Group

ACTIVE COMPARATOR

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

Procedure: exercise program consisting of only supervised exercises.

Interventions

exercise program consisting of supervised exercise and physical activity 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

Physical Activity Group

exercise program consisting of only supervised exercises. 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

Control Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Motor Activity; Shoulder Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Behavior; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 20, 2023
• Study Start: May 1, 2023
• Primary Completion: August 20, 2023
• Study Completion: August 25, 2023
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)