Skip to main content
OpenTrials
Completed

NCT Number: NCT05821283

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)-activity

    Time frame: change from baseline NPRS at 6 week

    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)

Secondary outcomes

  1. Numeric Pain Rating Scale (NPRS)-night

    Time frame: change from baseline NPRS at 6 week

    The pain will be measured 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)

  2. The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)

    Time frame: change from baseline ASES score at 6 week

    The ASES score ranges from 0-100. Higher scores indicate better functional ability.

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

    Time frame: change from baseline Quick DASH score at 6 week

    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).

  4. Rotator Cuff Quality of Life (RC-QOL)

    Time frame: change from baseline RC-QOL score at 6 week

    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.

  5. Western-Ontario Rotator Cuff Index (WORC)

    Time frame: change from baseline WORC score at 6 week

    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.

  6. Global Rate of Changes (GRC)

    Time frame: change from baseline GRC score at 6 week

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Does Physical Activity Provide Additional Benefit In Patients With Rotator Cuff Related Shoulder Pain? A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2023
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.