Rotator Cuff Tear or Rupture, Not Specified as TraumaticNCT05128474
Effectiveness of The Neuromuscular Control-Based Exercise Training in the Treatment of Partial-Thickness Rotator Cuff Tears
A study testing Conventional Exercise Training Group in people with Rotator Cuff Tear or Rupture, Not Specified as Traumatic and Pain, Shoulder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine and compare the effects of neuromuscular control exercises for the shoulder, and standard conservative exercise programs, which are different forms of exercise and have an important role in the treatment of partial thickness rotator cuff tears on treatment. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Rotator Cuff Tear or Rupture, Not Specified as Traumatic, Pain, Shoulder
- What is being tested?
- Conventional Exercise Training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2021to 15 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study.
Who cannot join
- Patients diagnosed with full-thickness or massive rotator cuff tear, patients who had undergone previous surgery, patients diagnosed with frozen shoulder or glenohumeral instability, and athletic patients younger than 40 years of age with symptoms of acute RC tear were not included in this study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Üniversitesi-Cerrahpaşa, Sağlık Bilimleri Fakültesi
Istanbul, Büyükçekmece, 34500
About this study
The aim of this study is to determine and compare the effects of neuromuscular control exercises for the shoulder, and standard conservative exercise programs, which are different forms of exercise and have an important role in the treatment of partial thickness rotator cuff tears on treatment. Thus, it is aimed to compare these exercise types with different mechanisms on treatment, to determine the place of neuromuscular control exercises in treatment and whether they are more effective than conventional exercises.
Read the detailed description
Rotator cuff (RC) tear shows different symptoms or sometimes can progress asymptomatic. The most common symptoms associated with rotator cuff tears are loss of shoulder range of motion (ROM), shoulder pain exacerbated by overhead activities, nocturnal pain, shoulder dysfunction, and functional limitations. Conservative treatment is the first and most preferred procedure in the treatment of partial tears. Conservative treatment includes patient education, activity modifications, medication, and physiotherapy and rehabilitation programs. In the literature search, it is seen that the studies on the conservative treatment of partial RC tears often include open kinetic chain-weighted standard exercises and strengthening exercise types. It is seen that stabilization and proprioception-based neuromuscular control exercises of the shoulder, which have an important role in restoring neuromuscular control, which is reported to be impaired in shoulder pathologies, are included in some studies and these exercises are generally added to standard treatment. However, it is not known whether neuromuscular control exercises are more effective than other exercises in the standard rehabilitation programs as a result of the combined application of these exercises in this patient group. For this purpose, it is aimed to compare the treatment efficacy of a group consisting of neuromuscular control exercises for the shoulder and a group consisting of conventional exercises and to determine the place of neuromuscular control exercises in treatment.
- Being tested
- Neuromuscular Control-Based Exercise Training Group, Conventional Exercise Training Group
- Keywords
- Rotator Cuff Tear, Physiotherapy, Rehabilitation, Neuromuscular Control, Rupture
- Medical subject headings
- Rotator Cuff Injuries, Rupture, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Control-Based Exercise Training GroupOther
Exercises for the neuromuscular control of the shoulder will be progressed by starting with the body weight, and in the following phases, a program that progresses to exercises that will improve the dynamic stabilization, coordination and proprioception of the shoulder will be applied to train the sensorimotor system. The exercise program will be performed twice a week for 8 weeks (16 sessions).
Conventional Exercise Training GroupOther
In this group, which will mainly benefit from conventional open kinetic chain strength exercises, a strengthening exercise program will be applied by advancing from body weight to elastic bands and weights. The exercise program will be performed twice a week for 8 weeks (16 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Neuromuscular Control-Based Exercise Training Group Receives: Other: Neuromuscular Control-Based Exercise Training Group |
| Group 2 | Active comparator | Conventional Exercise Training Group Receives: Other: Conventional Exercise Training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley Score
The Constant Murley Score is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.
Measured: The Constant Murley Score assessment will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Secondary outcomes (7)
The Numerical Pain Rating Scale (NPRS)
The levels of pain felt at rest / activity / night were measured using Numerical Pain Rating Scale (NPRS). Patients were asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
Measured: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Shoulder Joint Proprioception with Inclinometer
Proprioception of the shoulder joint is assessed by reproduction/reposition testing using an inclinometer. The patient will be evaluated by recording the difference between the angle from which the patient comes and the target angle determined.
Measured: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Shoulder Joint Range of Motion (ROM)
The shoulder flexion, abduction, internal and external rotation ROM were evaluated with goniometer while the patient was in supine position.
Measured: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Shoulder Joint Muscle Strength
Maximum isometric shoulder flexion, abduction, external and internal rotation strength measurements will be performed using a handheld dynamometer. During the test, while the participants were in a sitting position to measure shoulder flexion and abduction forces; for the measurement of external and internal rotational forces in the supine position, the shoulder is in 90° abduction and the elbow is in 90° flexion. For each movement, the measurements are repeated 3 times and the best measurement value is recorded.
Measured: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Quick DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire
Quick DASH is a 11-item questionnaire that questions the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the decreased functional level.
Measured: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Short Form 12 (SF-12)
SF-12 was used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Measured: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Global Rating of Change (GRC) Scale
Global Rating of Change (GRC) scale was used to assess the overall satisfaction levels of the patients. Patients were asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
Measured: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start3 Dec 2021
- Primary completion26 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear or Rupture, Not Specified as TraumaticStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Turkmen, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128474
- Sponsor's protocol ID
- IstanbulUC49
- Status last verified
- Aug 2023
- First submitted
- 22 Oct 2021
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of The Neuromuscular Control-Based Exercise Training in the Treatment of Partial-Thickness Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT05128474
- Acronym / sponsor ID
- IstanbulUC49
- Keywords
- Rotator Cuff Tear, Physiotherapy, Rehabilitation, Neuromuscular Control, Rupture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 22 Nov 2021 (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.
The aim of this study is to determine and compare the effects of neuromuscular control exercises for the shoulder, and standard conservative exercise programs, which are different forms of exercise and have an important role in the treatment of partial thickness rotator cuff tears on treatment. Thus, it is aimed to compare these exercise types with different mechanisms on treatment, to determine the place of neuromuscular control exercises in treatment and whether they are more effective than conventional exercises.
Detailed description
Rotator cuff (RC) tear shows different symptoms or sometimes can progress asymptomatic. The most common symptoms associated with rotator cuff tears are loss of shoulder range of motion (ROM), shoulder pain exacerbated by overhead activities, nocturnal pain, shoulder dysfunction, and functional limitations. Conservative treatment is the first and most preferred procedure in the treatment of partial tears. Conservative treatment includes patient education, activity modifications, medication, and physiotherapy and rehabilitation programs. In the literature search, it is seen that the studies on the conservative treatment of partial RC tears often include open kinetic chain-weighted standard exercises and strengthening exercise types. It is seen that stabilization and proprioception-based neuromuscular control exercises of the shoulder, which have an important role in restoring neuromuscular control, which is reported to be impaired in shoulder pathologies, are included in some studies and these exercises are generally added to standard treatment. However, it is not known whether neuromuscular control exercises are more effective than other exercises in the standard rehabilitation programs as a result of the combined application of these exercises in this patient group. For this purpose, it is aimed to compare the treatment efficacy of a group consisting of neuromuscular control exercises for the shoulder and a group consisting of conventional exercises and to determine the place of neuromuscular control exercises in treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Neuromuscular Control-Based Exercise Training GroupNeuromuscular Control-Based Exercise Training Group |
| Group 2 | Active comparator | Other: Conventional Exercise Training GroupConventional Exercise Training Group |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study.
Key exclusion criteria (1 listed)
- Patients diagnosed with full-thickness or massive rotator cuff tear, patients who had undergone previous surgery, patients diagnosed with frozen shoulder or glenohumeral instability, and athletic patients younger than 40 years of age with symptoms of acute RC tear were not included in this study.
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 |
|---|---|---|
| Neuromuscular Control-Based Exercise Training GroupExercises for the neuromuscular control of the shoulder will be progressed by starting with the body weight, and in the following phases, a program that progresses to exercises that will improve the dynamic stabilization, coordination and proprioception of the shoulder will be applied to train the sensorimotor system. The exercise program will be performed twice a week for 8 weeks (16 sessions). | Other | Group 1 |
| Conventional Exercise Training GroupIn this group, which will mainly benefit from conventional open kinetic chain strength exercises, a strengthening exercise program will be applied by advancing from body weight to elastic bands and weights. The exercise program will be performed twice a week for 8 weeks (16 sessions). | Other | Group 2 |
Primary outcome
Constant-Murley Score
Time frame: The Constant Murley Score assessment will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
The Constant Murley Score is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.
7 secondary outcomes
The Numerical Pain Rating Scale (NPRS)
Time frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Shoulder Joint Proprioception with Inclinometer
Time frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Shoulder Joint Range of Motion (ROM)
Time frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Shoulder Joint Muscle Strength
Time frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Quick DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire
Time frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Short Form 12 (SF-12)
Time frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Global Rating of Change (GRC) Scale
Time frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
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 16 Aug 2023.
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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 Conventional Exercise Training Group in people with Rotator Cuff Tear or Rupture, Not Specified as Traumatic and Pain, Shoulder, 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 1 inclusion and 1 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 16 Aug 2023. 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?
Constant-Murley Score (time frame: The Constant Murley Score assessment will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2023.