Rotator Cuff TearsNCT04552925
Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears
A study testing Rehabilitation in people with Rotator Cuff Tears, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
There are very few studies in the literature about conservative treatment of massive rotator cuff (RC) tears. Whether the treatment of massive RC tears is conservative or surgical is decided according to the age, activity level, expectation and additional pathologies of the patient. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2020to 30 Dec 2021
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral, non-traumatic massive rotator cuff tears according to Deorio and Cofield classification
- Age older than 50 years and attend 1-year follow-up assessment
Who cannot join
- Patients with symptomatic lesions in the contralateral shoulder
- Cuff tear arthropathy
- Glenohumeral osteoarthritis
- Pseudoparalytic shoulder
- Grade 3-4 fatty degeneration according to Goutallier classification
- History of involved shoulder surgery
- Major systemic conditions that disallowing exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears: A Randomized Controlled Study
There are very few studies in the literature about conservative treatment of massive rotator cuff (RC) tears. Whether the treatment of massive RC tears is conservative or surgical is decided according to the age, activity level, expectation and additional pathologies of the patient. The aim of conservative treatment is to make the patient functionally independent and to reduce pain. In recent years, there are different opinions in the literature about the effectiveness of conservative treatment of massive RC tears. However, in recent biomechanical studies, it has been reported that the RC and the deltoid, which remain intact in massive RC tears, can function well together.
The hypothesis of this study is that the deltoid-focused physiotherapy program, where strengthening exercises are performed with EMG biofeedback, will give more positive results in terms of range of motion (ROM), functional status, muscle strength, pain and patients satisfaction. aim of our study is to investigate the efficacy of electromyographic biofeedback (EMG-BF) device which was added to deltoid focused conservative treatment program in massive RC tears.
- Conditions
- Rotator Cuff Tears
- Being tested
- Rehabilitation
- Keywords
- massive rotator cuff tear, deltoid, electromyographic biofeedback, rehabilitation, nonoperative management
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Exercises and rehabilitation for massive rotator cuff tears
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Active comparator | Exercise group will receive ROM exercises, stretching and anterior deltoid re-education exercises described by Levy et al. Subjects will treated at the clinic three times per week for 6 weeks (18 sessions). Receives: Other: Rehabilitation |
| EMG-BF Group | Experimental | EMG-BF group will receive the same exercises as with the other group, but deltoid re-education exercises were performed under the guidance of EMG-BF device. All subjects will treated at the clinic three times per week for 6 weeks (18 sessions). Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
American shoulder and elbow (ASES) score
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) is a standard shoulder assessment form, which is comprised of objective and subjective sections and prepared by shoulder and elbow surgeons.
Measured: 12 months
Deltoid Strength
Measurement of the strength of the deltoid muscle with a digital dynamometer.
Measured: 12 months
Secondary outcomes (3)
Range of Motion (ROM)
Active ROM will evaluate with a universal goniometer.
Measured: 12 months
Numeric Pain Rating Scale (NPRS)
Participants' level of pain will assess by numeric pain rating scale (NPRS).
Measured: 12 months
Global rating of change scale (GRCS)
The global rating of change scale (GRCS) which is five-point Likert scale will be use to evaluate the difference between the participants' health status from their perspective. It is ranging from -2 (very much worse), through 0 (unchanged) to +2 (much better).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start22 Sep 2020
- Primary completion29 Dec 2020
- Study completion30 Dec 2021
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 TearsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Pelin Tiryaki, Istanbul University - Cerrahpasa
- Investigators
- Derya Çelik, Professor, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552925
- Sponsor's protocol ID
- 2016/1507
- Status last verified
- Nov 2024
- First submitted
- 12 Sep 2020
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tiryaki P, Celik D, Bilsel K, Ersen A. Effectiveness of Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears: A Randomized Controlled Study. Am J Phys Med Rehabil. 2023 May 1;102(5):419-426. doi: 10.1097/PHM.0000000000002111. Epub 2022 Sep 23.
PubMed 36166658
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04552925
- Acronym / sponsor ID
- 2016/1507
- Conditions
- Rotator Cuff Tears
- Keywords
- massive rotator cuff tear, deltoid, electromyographic biofeedback, rehabilitation, nonoperative management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 17 Sep 2020 (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.
There are very few studies in the literature about conservative treatment of massive rotator cuff (RC) tears. Whether the treatment of massive RC tears is conservative or surgical is decided according to the age, activity level, expectation and additional pathologies of the patient. The aim of conservative treatment is to make the patient functionally independent and to reduce pain. In recent years, there are different opinions in the literature about the effectiveness of conservative treatment of massive RC tears. However, in recent biomechanical studies, it has been reported that the RC and the deltoid, which remain intact in massive RC tears, can function well together.
The hypothesis of this study is that the deltoid-focused physiotherapy program, where strengthening exercises are performed with EMG biofeedback, will give more positive results in terms of range of motion (ROM), functional status, muscle strength, pain and patients satisfaction. aim of our study is to investigate the efficacy of electromyographic biofeedback (EMG-BF) device which was added to deltoid focused conservative treatment program in massive RC tears.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Active comparator | Other: RehabilitationExercise group will receive ROM exercises, stretching and anterior deltoid re-education exercises described by Levy et al. Subjects will treated at the clinic three times per week for 6 weeks (18 sessions). |
| EMG-BF Group | Experimental | Other: RehabilitationEMG-BF group will receive the same exercises as with the other group, but deltoid re-education exercises were performed under the guidance of EMG-BF device. All subjects will treated at the clinic three times per week for 6 weeks (18 sessions). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral, non-traumatic massive rotator cuff tears according to Deorio and Cofield classification
- Age older than 50 years and attend 1-year follow-up assessment
Key exclusion criteria (7 listed)
- Patients with symptomatic lesions in the contralateral shoulder
- Cuff tear arthropathy
- Glenohumeral osteoarthritis
- Pseudoparalytic shoulder
- Grade 3-4 fatty degeneration according to Goutallier classification
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 |
|---|---|---|
| RehabilitationExercises and rehabilitation for massive rotator cuff tears | Other | EMG-BF Group, Exercise Group |
Primary outcome
American shoulder and elbow (ASES) score
Time frame: 12 months
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) is a standard shoulder assessment form, which is comprised of objective and subjective sections and prepared by shoulder and elbow surgeons.
Deltoid Strength
Time frame: 12 months
Measurement of the strength of the deltoid muscle with a digital dynamometer.
3 secondary outcomes
Range of Motion (ROM)
Time frame: 12 months
Numeric Pain Rating Scale (NPRS)
Time frame: 12 months
Global rating of change scale (GRCS)
Time frame: 12 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 8 Nov 2024.
- Results publication: PubMed 36166658Tiryaki P, Celik D, Bilsel K, Ersen A. Effectiveness of Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears: A Randomized Controlled Study. Am J Phys Med Rehabil. 2023 May 1;102(5):419-426. doi: 10.1097/PHM.0000000000002111. Epub 2022 Sep 23.
- Individual participant dataSharing planned: No
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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.
Derya Çelik, Professor study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Rotator Cuff Tears, run by Istanbul University - Cerrahpasa 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 2 inclusion and 7 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 8 Nov 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?
American shoulder and elbow (ASES) score (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT04552925, 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 8 Nov 2024.