Rotator Cuff InjuriesNCT05821283
Does Physical Activity Provide Additional Benefit In Patients With Rotator Cuff Related Shoulder Pain?
A study testing exercise program consisting of supervised exercise and physical activity and exercise program consisting of only supervised exercises. in people with Rotator Cuff Injuries, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- exercise program consisting of supervised exercise and physical activity and exercise program consisting of only supervised exercises.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 25 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Physical Activity Provide Additional Benefit In Patients With Rotator Cuff Related Shoulder Pain? A Randomized Controlled Trial
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.
Read the 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
- Being tested
- exercise program consisting of supervised exercise and physical activity, exercise program consisting of only supervised exercises.
- Keywords
- rotator cuff, physical activity, shoulder pain
- Medical subject headings
- Rotator Cuff Injuries, Motor Activity, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise program consisting of supervised exercise and physical activityProcedure or surgery
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 or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: exercise program consisting of only supervised exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: change from baseline NPRS at 6 week
Secondary outcomes (6)
Numeric Pain Rating Scale (NPRS)-night
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)
Measured: change from baseline NPRS at 6 week
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)
The ASES score ranges from 0-100. Higher scores indicate better functional ability.
Measured: change from baseline ASES score at 6 week
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).
Measured: change from baseline Quick DASH score at 6 week
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.
Measured: change from baseline RC-QOL score at 6 week
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.
Measured: change from baseline WORC score at 6 week
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.
Measured: change from baseline GRC score at 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 May 2023
- Primary completion20 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Celik, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821283
- Sponsor's protocol ID
- DR2023
- Status last verified
- May 2025
- First submitted
- 16 Mar 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ozturk U, Celik D. Does physical activity provide additional benefit in individuals with rotator cuff related shoulder pain? Musculoskelet Sci Pract. 2026 Apr;82:103498. doi: 10.1016/j.msksp.2026.103498. Epub 2026 Jan 9.
PubMed 41534301
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Physical Activity Provide Additional Benefit In Patients With Rotator Cuff Related Shoulder Pain? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05821283
- Acronym / sponsor ID
- DR2023
- Conditions
- Rotator Cuff Injuries
- Keywords
- rotator cuff, physical activity, shoulder pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Group | Experimental | Procedure: exercise program consisting of supervised exercise and physical activityThe Physical Activity (PAG) was included in an exercise program consisting of supervised exercise and physical activity (30 minutes of moderate-intensity walking). |
| Control Group | Active comparator | Procedure: exercise program consisting of only supervised exercises.The Control Group (CG) was included in the program consisting of only supervised exercises. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise program consisting of supervised exercise and physical activityThe 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 | Procedure or surgery | Physical Activity Group |
| 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 | Procedure or surgery | Control Group |
Primary outcome
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)
6 secondary outcomes
Numeric Pain Rating Scale (NPRS)-night
Time frame: change from baseline NPRS at 6 week
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)
Time frame: change from baseline ASES score at 6 week
Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH)
Time frame: change from baseline Quick DASH score at 6 week
Rotator Cuff Quality of Life (RC-QOL)
Time frame: change from baseline RC-QOL score at 6 week
Western-Ontario Rotator Cuff Index (WORC)
Time frame: change from baseline WORC score at 6 week
Global Rate of Changes (GRC)
Time frame: change from baseline GRC score at 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 41534301Ozturk U, Celik D. Does physical activity provide additional benefit in individuals with rotator cuff related shoulder pain? Musculoskelet Sci Pract. 2026 Apr;82:103498. doi: 10.1016/j.msksp.2026.103498. Epub 2026 Jan 9.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise program consisting of supervised exercise and physical activity and exercise program consisting of only supervised exercises. in people with Rotator Cuff Injuries, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS)-activity (time frame: change from baseline NPRS at 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05821283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.