Rotator Cuff SyndromeNCT06535750
Comparison Of The Effects Of Conventional Physiotherapy And Strengthening Exercises With Rotator Cuff Syndrome
A study testing Exercise in people with Rotator Cuff Syndrome and Physiotherapy, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
Various options are available for the treatment of rotator cuff syndrome, including conservative and surgical. Conservative treatment methods include activity modification, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections (CSIs), and physiotherapy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Rotator Cuff Syndrome, Physiotherapy
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 22 Jun 2024
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having complaints for at least three months
- having positive Empty can test
- having rotator cuff injury
- having loss of function in the shoulder and volunteering to participate in the study
Who cannot join
- cardiovascular disease that would interfere with the rehabilitation process,
- who had neurological or systemic musculoskeletal disease
- who had undergone upper extremity surgery
- who had upper extremity scapula fracture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Physical Therapy and Rehabilitation Clinic of Istanbul Health Sciences University Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, Küçükçekmece, 34303
About this study
Official title: Comparison Of The Effects Of Conventional Physiotherapy And Strengthening Exercises Additional To Conventional Physiotherapy On Pain, Muscle Strength, Joint Range Of Motion, Functionality And Quality Of Life In Patients With Rotator Cuff Syndrome
Various options are available for the treatment of rotator cuff syndrome, including conservative and surgical. Conservative treatment methods include activity modification, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections (CSIs), and physiotherapy. Physiotherapy methods include various interventions such as manual therapy, exercise, and electrotherapy. Although these treatments do not directly treat the specific pathology, they help correct rotator cuff and scapular muscle weakness and dysfunction, reduce the tightness of the posterior capsule and other soft tissues, and relieve pain and dysfunction. It focuses on correcting the postural abnormalities that contribute to the disease.
In our study, the investigators aimed to determine the effects of rehabilitation components in the conservative treatment of patients with rotator cuff syndrome and to determine the effects of strengthening exercises on the functional status of the patients.
Read the detailed description
Rotator cuff syndrome (RCS), also known as rotator cuff tendonitis, is characterised by intense pain, functional impairment, loss of shoulder range of motion (ROM), nocturnal pain, and limitations in activities of daily living. It is a common problem in the ageing population and its patophysiology may be the result of tendon degeneration resulting from microtrauma (repetitive activities, overload) or traumatic injury.
Groups Participants were randomly divided into two treatment groups. There are 10 patients in each group. The patients in the control group received a standard treatment programme, while the patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. Treatment sessions for both groups lasted 50-55 minutes and were performed three days a week. Details of the study groups are given below.
Control Group
Patients in the control group received a standard treatment programme. This programme included the following:
Passive stretching exercises were performed 10 repetitions for each movement (shoulder flexion, abduction, adduction, internal rotation, external rotation). Codman exercises were performed 15 repetitions (with 1kg dumbbell). Shoulder isometric exercises were performed 15 repetitions for each movement (ball press, clockwise and anti-clockwise ball rotation, finger slide on the wall). Wand exercises were performed 15 repetitions (shoulder abduction, internal rotation, external rotation). Electrotherapy was applied for 20 minutes and ice therapy was applied for 20 minutes.7-9 Experimental Group
Patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. This programme included the following:
Strengthening Exercises: Low-row, biceps strengthening, shoulder horizontal abduction and shoulder horizontal adduction, external rotation. After the pain decreased, strengthening exercises for subscapularis, infraspinatus, supraspinatus, teres minor, deltoid and scapulothoracic muscles were performed. The colour of the Theraband was chosen between yellow, red, green, blue and red to the extent tolerated by the patient.
- Conditions
- Rotator Cuff Syndrome, Physiotherapy
- Being tested
- Exercise
- Keywords
- Rotator Cuff, Exercise, Pain
- Medical subject headings
- Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participants were randomly divided into two treatment groups. There are 10 patients in each group. The patients in the control group received a standard treatment programme, while the patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. Treatment sessions for both groups lasted 50-55 minutes and were performed three days a week. Details of the study groups are given below.
| Study group | Role | What they receive |
|---|---|---|
| Rotator Cuff Patients with used to conventional rehabilitation | Experimental | Patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. This programme included the following:
Strengthening Exercises: Low-row, biceps strengthening, shoulder horizontal abduction and shoulder horizontal adduction, external rotation. After the pain decreased, strengthening exercises for subscapularis, infraspinatus, supraspinatus, teres minor, deltoid and scapulothoracic muscles were performed. The colour of the Theraband was chosen between yellow, red, green, blue and red to the extent tolerated by the patient. Receives: Other: Exercise |
| Rotator Cuff Patients with used to conventional rehabilitation add to strenght exercise. | Experimental | Patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. This programme included the following:
Strengthening Exercises: Low-row, biceps strengthening, shoulder horizontal abduction and shoulder horizontal adduction, external rotation. After the pain decreased, strengthening exercises for subscapularis, infraspinatus, supraspinatus, teres minor, deltoid and scapulothoracic muscles were performed. The colour of the Theraband was chosen between yellow, red, green, blue and red to the extent tolerated by the patient. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability Questionnaire for Arm, Shoulder and Hand (Quick DASH):
Quick DASH was used as the primary outcome measure because it is a questionnaire that assesses upper extremity injuries and symptoms and measures their impact on patients' activities of daily living. Each section of the Quick-DASH questionnaire yields a score between 0 and 100 (0= no disability, 100= maximum disability).10,11
Measured: 3 months
Secondary outcomes (2)
Western Ontario Rotator Cuff Index (WORC)
WORC was used to assess the impact of rotator cuff problems on quality of life.(Kirkley Alvarez) Each question is answered with a 100mm VAS. The total is between 0 and 2100, with lower scores indicating higher quality of life.
Measured: 1 months
Nothingam Health Profile (NSP):
The NSP was used to measure the general health status and quality of life of the patients. The scoring of the sections ranges from 0-100, with higher scores indicating health problems.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2024
- Study completion22 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff SyndromeStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Şahbaz, University of Beykent
- Investigators
- Yasemin ŞAHBAZ, Study director, Istanbul Beykent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535750
- Sponsor's protocol ID
- UBeykent-6
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It was not considered appropriate to share individual information.
Publications
Gomoll AH, Katz JN, Warner JJ, Millett PJ. Rotator cuff disorders: recognition and management among patients with shoulder pain. Arthritis Rheum. 2004 Dec;50(12):3751-61. doi: 10.1002/art.20668. No abstract available.
PubMed 15593187Galetta MD, Keller RE, Sabbag OD, Linderman SE, Fury MS, Medina G, O'Donnell EA, Cheng TTW, Harris E, Oh LS. Rehabilitation variability after rotator cuff repair. J Shoulder Elbow Surg. 2021 Jun;30(6):e322-e333. doi: 10.1016/j.jse.2020.11.016. Epub 2021 Jan 5.
PubMed 33418088
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effects Of Conventional Physiotherapy And Strengthening Exercises Additional To Conventional Physiotherapy On Pain, Muscle Strength, Joint Range Of Motion, Functionality And Quality Of Life In Patients With Rotator Cuff Syndrome
- ClinicalTrials.gov ID
- NCT06535750
- Acronym / sponsor ID
- UBeykent-6
- Conditions
- Rotator Cuff Syndrome, Physiotherapy
- Keywords
- Rotator Cuff, Exercise, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 2 Aug 2024 (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.
Various options are available for the treatment of rotator cuff syndrome, including conservative and surgical. Conservative treatment methods include activity modification, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections (CSIs), and physiotherapy. Physiotherapy methods include various interventions such as manual therapy, exercise, and electrotherapy. Although these treatments do not directly treat the specific pathology, they help correct rotator cuff and scapular muscle weakness and dysfunction, reduce the tightness of the posterior capsule and other soft tissues, and relieve pain and dysfunction. It focuses on correcting the postural abnormalities that contribute to the disease.
In our study, the investigators aimed to determine the effects of rehabilitation components in the conservative treatment of patients with rotator cuff syndrome and to determine the effects of strengthening exercises on the functional status of the patients.
Detailed description
Rotator cuff syndrome (RCS), also known as rotator cuff tendonitis, is characterised by intense pain, functional impairment, loss of shoulder range of motion (ROM), nocturnal pain, and limitations in activities of daily living. It is a common problem in the ageing population and its patophysiology may be the result of tendon degeneration resulting from microtrauma (repetitive activities, overload) or traumatic injury.
Groups Participants were randomly divided into two treatment groups. There are 10 patients in each group. The patients in the control group received a standard treatment programme, while the patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. Treatment sessions for both groups lasted 50-55 minutes and were performed three days a week. Details of the study groups are given below.
Control Group
Patients in the control group received a standard treatment programme. This programme included the following:
Passive stretching exercises were performed 10 repetitions for each movement (shoulder flexion, abduction, adduction, internal rotation, external rotation). Codman exercises were performed 15 repetitions (with 1kg dumbbell). Shoulder isometric exercises were performed 15 repetitions for each movement (ball press, clockwise and anti-clockwise ball rotation, finger slide on the wall). Wand exercises were performed 15 repetitions (shoulder abduction, internal rotation, external rotation). Electrotherapy was applied for 20 minutes and ice therapy was applied for 20 minutes.7-9 Experimental Group
Patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. This programme included the following:
Strengthening Exercises: Low-row, biceps strengthening, shoulder horizontal abduction and shoulder horizontal adduction, external rotation. After the pain decreased, strengthening exercises for subscapularis, infraspinatus, supraspinatus, teres minor, deltoid and scapulothoracic muscles were performed. The colour of the Theraband was chosen between yellow, red, green, blue and red to the extent tolerated by the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotator Cuff Patients with used to conventional rehabilitation | Experimental | Other: ExercisePatients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. This programme included the following: Strengthening Exercises: Low-row, biceps strengthening, shoulder horizontal abduction and shoulder horizontal adduction, external rotation. After the pain decreased, strengthening exercises for subscapularis, infraspinatus, supraspinatus, teres minor, deltoid and scapulothoracic muscles were performed. The colour of the Theraband was chosen between yellow, red, green, blue and red to the extent tolerated by the patient. |
| Rotator Cuff Patients with used to conventional rehabilitation add to strenght exercise. | Experimental | Other: ExercisePatients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. This programme included the following: Strengthening Exercises: Low-row, biceps strengthening, shoulder horizontal abduction and shoulder horizontal adduction, external rotation. After the pain decreased, strengthening exercises for subscapularis, infraspinatus, supraspinatus, teres minor, deltoid and scapulothoracic muscles were performed. The colour of the Theraband was chosen between yellow, red, green, blue and red to the extent tolerated by the patient. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- having complaints for at least three months
- having positive Empty can test
- having rotator cuff injury
- having loss of function in the shoulder and volunteering to participate in the study
Key exclusion criteria (4 listed)
- cardiovascular disease that would interfere with the rehabilitation process,
- who had neurological or systemic musculoskeletal disease
- who had undergone upper extremity surgery
- who had upper extremity scapula fracture
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 |
|---|---|---|
| ExerciseParticipants were randomly divided into two treatment groups. There are 10 patients in each group. The patients in the control group received a standard treatment programme, while the patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. Treatment sessions for both groups lasted 50-55 minutes and were performed three days a week. Details of the study groups are given below. | Other | Rotator Cuff Patients with used to conventional rehabilitation, Rotator Cuff Patients with used to conventional rehabilitation add to strenght exercise. |
Primary outcome
Disability Questionnaire for Arm, Shoulder and Hand (Quick DASH):
Time frame: 3 months
Quick DASH was used as the primary outcome measure because it is a questionnaire that assesses upper extremity injuries and symptoms and measures their impact on patients' activities of daily living. Each section of the Quick-DASH questionnaire yields a score between 0 and 100 (0= no disability, 100= maximum disability).10,11
2 secondary outcomes
Western Ontario Rotator Cuff Index (WORC)
Time frame: 1 months
Nothingam Health Profile (NSP):
Time frame: 1 months
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 2 Aug 2024.
- Background: PubMed 15593187Gomoll AH, Katz JN, Warner JJ, Millett PJ. Rotator cuff disorders: recognition and management among patients with shoulder pain. Arthritis Rheum. 2004 Dec;50(12):3751-61. doi: 10.1002/art.20668. No abstract available.
- Background: PubMed 33418088Galetta MD, Keller RE, Sabbag OD, Linderman SE, Fury MS, Medina G, O'Donnell EA, Cheng TTW, Harris E, Oh LS. Rehabilitation variability after rotator cuff repair. J Shoulder Elbow Surg. 2021 Jun;30(6):e322-e333. doi: 10.1016/j.jse.2020.11.016. Epub 2021 Jan 5.
- Individual participant dataSharing planned: No. It was not considered appropriate to share individual information.
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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.
Yasemin ŞAHBAZ study director
Istanbul Beykent University
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 in people with Rotator Cuff Syndrome and Physiotherapy, run by University of Beykent 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 4 inclusion and 4 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 2 Aug 2024. 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?
Disability Questionnaire for Arm, Shoulder and Hand (Quick DASH): (time frame: 3 months). 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 NCT06535750, which also lists 2 linked publications.
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 2 Aug 2024.