Rotator Cuff TearsMobilizationNCT05933382
Investigation of the Effects of Mulligan Mobilization and Corticosteroid Injection in Rotator Cuff Lesions
A study testing Corticosteroid Group and Mulligan Group in people with Rotator Cuff Tears, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronic shoulder pain, predominantly caused by rotator cuff disorders represents one of the most frequently encountered musculoskeletal issues within the community. Rotator cuff tears are a crucial pathophysiological contributor to shoulder pain. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Corticosteroid Group and Mulligan Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 10 Feb 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 40 and 60
- Not having had any shoulder surgery before
- Having been diagnosed with a rotator cuff lesion
- Not having any orthopedic or cardiac problems that could hinder participation in the study and evaluation
Who cannot join
- Having a pathology affecting the shoulder area
- Having had any shoulder surgery
- Individuals who are non-cooperative or have mental problems
- Individuals with neurological, cardiac, and vascular problems
- Individuals who have participated in any physiotherapy program directed towards the shoulder in the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Mobilization With Movement Technique and Corticosteroid Injection on Pain, Functionality, and Proprioception in Rotator Cuff Lesions
Chronic shoulder pain, predominantly caused by rotator cuff disorders represents one of the most frequently encountered musculoskeletal issues within the community. Rotator cuff tears are a crucial pathophysiological contributor to shoulder pain. Individuals afflicted with this condition frequently report nocturnal intensification of pain and movement-specific aggravation, especially during overhead activities. The condition is frequently correlated with functional impairment, with many patients noting a sensation of weakness. Conservative treatment of the rotator cuff tear consists of a wide range of procedures such as exercise therapy; and/or local anesthetic, ice/heat therapy, electrotherapy, various types of manual therapy and joint mobilization procedures. Corticosteroid injection approach is an alternative method to these applications The subacromial corticosteroid injection is an intervention technique that has been utilized for short-term relief over numerous years.Given the restricted self-repair capabilities of tendons the consideration of novel biological treatment strategies for tendinopathies has gained prominence in recent times. Nonetheless, there remains a lack of sufficient scientific evidence to substantiate their efficacy.Mulligan mobilization techniques are manual therapy techniques that aim to increase normal joint movement and reduce pain levels by correcting the biomechanical structure of joint surfaces to provide a pain-free range of motion. A review of the literature reveals no studies comparing the Mulligan mobilization technique and corticosteroid injections in rotator cuff tears. The aim of our study is to examine the effects of the Mulligan mobilization technique and corticosteroid injections on pain, range of motion, functionality and proprioception in individuals with rotator cuff tears.
Read the detailed description
Individuals diagnosed with rotator cuff rupture presenting at Medipol Esenler Hospital will be included in the study. Participants will be randomly divided into 2 groups. A conventional treatment program will be applied to individuals in both groups 5 days a week for 3 weeks. The conventional exercise program will consist of wand exercises, Codman exercises, stretching exercises for all ranges of motion, and TENS (100Hz, 15 minutes). A corticosteroid injection will be administered to the shoulder region of the first group prior to treatment. For the second group, in addition to the conventional treatment program, a mobilization technique with movement will be applied twice a week, with 10 repetitions. Inclusion Criteria:
- Being between the ages of 40 and 60
- Not having had any shoulder surgery before
- Having been diagnosed with a rotator cuff lesion
- Not having any orthopedic or cardiac problems that could hinder participation in the study and evaluation
Exclusion Criteria:
- Having a pathology affecting the shoulder area
- Having had any shoulder surgery
- Individuals who are non-cooperative or have mental problems
- Individuals with neurological, cardiac, and vascular problems
- Individuals who have participated in any physiotherapy program directed towards the shoulder in the last three months
Evaluation Scales to be Used:
- Visual Analog Scale - VAS
- Joint Range of Motion - Becure extremity ROM
- Joint Position Sense - Becure extremity ROM
- Disability of the Arm, Shoulder and Hand Questionnaire - DASH
Evaluation Methods:
- Visual Analog Scale (VAS) The Visual Analog Scale is a commonly preferred evaluation method in the clinic and literature studies for measuring pain intensity. Patients' pain levels are determined by numbering 0-10. 0 indicates no pain, and 10 represents the most severe pain experienced.
- Joint Range of Motion The normal joint range of motion was evaluated with the Becure Extremity ROM. Becure Extremity ROM is a system that allows for the objective measurement of joint range of motion by using its camera and sensors to detect reference points during extremity movements. In the Becure Extremity ROM system, the patient is expected to stand in front of the camera and perform the movement to be measured. In our study, the shoulder joint's flexion, extension, abduction, internal and external rotation ranges of motion were evaluated in degrees with Becure Extremity ROM.
- Joint Position Sense The joint position sense measurements of the individuals participating in the study will be evaluated with a goniometer. Individuals will be asked to lift their shoulder to a certain degree, and then bring it back to the same angle value with their eyes closed. The angle value formed when eyes are open and closed will be recorded, and the difference between shoulder angles will be calculated. Joint position sense will be applied at 30 and 60 degrees of flexion and abduction movements.
- Disability of the Arm, Shoulder, and Hand Questionnaire (DASH) The DASH, developed as a result of the collaboration of the American Academy of Orthopedic Surgeons and other groups, is a scale that evaluates physical restrictions and function in upper extremity lesions[18]. The DASH questionnaire consists of three subsections. The first part contains 30 questions; 21 questions evaluate the difficulties encountered in the patient's daily life functions, 5 questions are about symptoms, and the other 4 questions assess social life, work, sleep, and the individual's self-confidence. The part with 4 questions (optional Work Module (DASH- FS)) measures the difficulties encountered in the individual's work life.
- Conditions
- Rotator Cuff Tears
- Being tested
- Corticosteroid Group, Mulligan Group
- Keywords
- Mobilization with movement, Rotator cuff, Corticosteroid
- 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.
Corticosteroid GroupOther
Conventional exercise and corticosteroid injection
Mulligan GroupOther
Conventional exercise and mulligan mobilization
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid Group | Experimental | A conventional treatment program will be applied to individuals in both groups 5 days a week for 3 weeks. The conventional exercise program will consist of wand exercises, Codman exercises, stretching exercises for all ranges of motion, and TENS (100Hz, 15 minutes). A corticosteroid injection will be administered to the shoulder region of the first group prior to treatment. Receives: Other: Corticosteroid Group |
| Mulligan Group | Experimental | A conventional treatment program will be applied to individuals in both groups 5 days a week for 3 weeks. The conventional exercise program will consist of wand exercises, Codman exercises, stretching exercises for all ranges of motion, and TENS (100Hz, 15 minutes). In addition to the conventional treatment program, a mobilization technique with movement will be applied twice a week, with 10 repetitions. Receives: Other: Mulligan Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visuel Analogue Scale (VAS)
The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 5 minutes
Normal range of motion and proprioception
Normal range of motion and proprioception can be measured with Becure Extremity ROM
Measured: 10 minutes
Secondary outcomes (1)
Functionality
Arm, Shoulder and Hand Problems Survey
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Jul 2023
- Primary completion6 Sep 2023
- Study completion10 Feb 2024
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.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, burak menek, Istanbul Medipol University Hospital
- Investigators
- Merve YILMAZ MENEK, PhD, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933382
- Sponsor's protocol ID
- MedipolPTR
- Acronym
- Mobilization
- Status last verified
- Feb 2024
- First submitted
- 12 Jun 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Menek B, Menek MY. The efficacy of Mulligan mobilization and corticosteroid injection on pain, functionality, and proprioception in rotator cuff tears: A randomized controlled trial. J Hand Ther. 2025 Jul-Sep;38(3):410-417. doi: 10.1016/j.jht.2024.12.016. Epub 2025 Feb 6.
PubMed 39919923
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Mobilization With Movement Technique and Corticosteroid Injection on Pain, Functionality, and Proprioception in Rotator Cuff Lesions
- ClinicalTrials.gov ID
- NCT05933382
- Acronym / sponsor ID
- Mobilization / MedipolPTR
- Conditions
- Rotator Cuff Tears
- Keywords
- Mobilization with movement, Rotator cuff, Corticosteroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 6 Jul 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.
Chronic shoulder pain, predominantly caused by rotator cuff disorders represents one of the most frequently encountered musculoskeletal issues within the community. Rotator cuff tears are a crucial pathophysiological contributor to shoulder pain. Individuals afflicted with this condition frequently report nocturnal intensification of pain and movement-specific aggravation, especially during overhead activities. The condition is frequently correlated with functional impairment, with many patients noting a sensation of weakness. Conservative treatment of the rotator cuff tear consists of a wide range of procedures such as exercise therapy; and/or local anesthetic, ice/heat therapy, electrotherapy, various types of manual therapy and joint mobilization procedures. Corticosteroid injection approach is an alternative method to these applications The subacromial corticosteroid injection is an intervention technique that has been utilized for short-term relief over numerous years.Given the restricted self-repair capabilities of tendons the consideration of novel biological treatment strategies for tendinopathies has gained prominence in recent times. Nonetheless, there remains a lack of sufficient scientific evidence to substantiate their efficacy.Mulligan mobilization techniques are manual therapy techniques that aim to increase normal joint movement and reduce pain levels by correcting the biomechanical structure of joint surfaces to provide a pain-free range of motion. A review of the literature reveals no studies comparing the Mulligan mobilization technique and corticosteroid injections in rotator cuff tears. The aim of our study is to examine the effects of the Mulligan mobilization technique and corticosteroid injections on pain, range of motion, functionality and proprioception in individuals with rotator cuff tears.
Detailed description
Individuals diagnosed with rotator cuff rupture presenting at Medipol Esenler Hospital will be included in the study. Participants will be randomly divided into 2 groups. A conventional treatment program will be applied to individuals in both groups 5 days a week for 3 weeks. The conventional exercise program will consist of wand exercises, Codman exercises, stretching exercises for all ranges of motion, and TENS (100Hz, 15 minutes). A corticosteroid injection will be administered to the shoulder region of the first group prior to treatment. For the second group, in addition to the conventional treatment program, a mobilization technique with movement will be applied twice a week, with 10 repetitions. Inclusion Criteria:
- Being between the ages of 40 and 60
- Not having had any shoulder surgery before
- Having been diagnosed with a rotator cuff lesion
- Not having any orthopedic or cardiac problems that could hinder participation in the study and evaluation
Exclusion Criteria:
- Having a pathology affecting the shoulder area
- Having had any shoulder surgery
- Individuals who are non-cooperative or have mental problems
- Individuals with neurological, cardiac, and vascular problems
- Individuals who have participated in any physiotherapy program directed towards the shoulder in the last three months
Evaluation Scales to be Used:
- Visual Analog Scale - VAS
- Joint Range of Motion - Becure extremity ROM
- Joint Position Sense - Becure extremity ROM
- Disability of the Arm, Shoulder and Hand Questionnaire - DASH
Evaluation Methods:
- Visual Analog Scale (VAS) The Visual Analog Scale is a commonly preferred evaluation method in the clinic and literature studies for measuring pain intensity. Patients' pain levels are determined by numbering 0-10. 0 indicates no pain, and 10 represents the most severe pain experienced.
- Joint Range of Motion The normal joint range of motion was evaluated with the Becure Extremity ROM. Becure Extremity ROM is a system that allows for the objective measurement of joint range of motion by using its camera and sensors to detect reference points during extremity movements. In the Becure Extremity ROM system, the patient is expected to stand in front of the camera and perform the movement to be measured. In our study, the shoulder joint's flexion, extension, abduction, internal and external rotation ranges of motion were evaluated in degrees with Becure Extremity ROM.
- Joint Position Sense The joint position sense measurements of the individuals participating in the study will be evaluated with a goniometer. Individuals will be asked to lift their shoulder to a certain degree, and then bring it back to the same angle value with their eyes closed. The angle value formed when eyes are open and closed will be recorded, and the difference between shoulder angles will be calculated. Joint position sense will be applied at 30 and 60 degrees of flexion and abduction movements.
- Disability of the Arm, Shoulder, and Hand Questionnaire (DASH) The DASH, developed as a result of the collaboration of the American Academy of Orthopedic Surgeons and other groups, is a scale that evaluates physical restrictions and function in upper extremity lesions[18]. The DASH questionnaire consists of three subsections. The first part contains 30 questions; 21 questions evaluate the difficulties encountered in the patient's daily life functions, 5 questions are about symptoms, and the other 4 questions assess social life, work, sleep, and the individual's self-confidence. The part with 4 questions (optional Work Module (DASH- FS)) measures the difficulties encountered in the individual's work life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid Group | Experimental | Other: Corticosteroid GroupA conventional treatment program will be applied to individuals in both groups 5 days a week for 3 weeks. The conventional exercise program will consist of wand exercises, Codman exercises, stretching exercises for all ranges of motion, and TENS (100Hz, 15 minutes). A corticosteroid injection will be administered to the shoulder region of the first group prior to treatment. |
| Mulligan Group | Experimental | Other: Mulligan GroupA conventional treatment program will be applied to individuals in both groups 5 days a week for 3 weeks. The conventional exercise program will consist of wand exercises, Codman exercises, stretching exercises for all ranges of motion, and TENS (100Hz, 15 minutes). In addition to the conventional treatment program, a mobilization technique with movement will be applied twice a week, with 10 repetitions. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being between the ages of 40 and 60
- Not having had any shoulder surgery before
- Having been diagnosed with a rotator cuff lesion
- Not having any orthopedic or cardiac problems that could hinder participation in the study and evaluation
Key exclusion criteria (5 listed)
- Having a pathology affecting the shoulder area
- Having had any shoulder surgery
- Individuals who are non-cooperative or have mental problems
- Individuals with neurological, cardiac, and vascular problems
- Individuals who have participated in any physiotherapy program directed towards the shoulder in the last three months
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 |
|---|---|---|
| Corticosteroid GroupConventional exercise and corticosteroid injection | Other | Corticosteroid Group |
| Mulligan GroupConventional exercise and mulligan mobilization | Other | Mulligan Group |
Primary outcome
Visuel Analogue Scale (VAS)
Time frame: 5 minutes
The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Normal range of motion and proprioception
Time frame: 10 minutes
Normal range of motion and proprioception can be measured with Becure Extremity ROM
1 secondary outcome
Functionality
Time frame: 5 minutes
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 20 Feb 2024.
- Derived from this study: PubMed 39919923Menek B, Menek MY. The efficacy of Mulligan mobilization and corticosteroid injection on pain, functionality, and proprioception in rotator cuff tears: A randomized controlled trial. J Hand Ther. 2025 Jul-Sep;38(3):410-417. doi: 10.1016/j.jht.2024.12.016. Epub 2025 Feb 6.
- 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.
Merve YILMAZ MENEK, PhD study director
Medipol 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 Corticosteroid Group and Mulligan Group in people with Rotator Cuff Tears, run by Istanbul Medipol University Hospital 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 5 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 20 Feb 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?
Visuel Analogue Scale (VAS) (time frame: 5 minutes). 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 NCT05933382, 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 20 Feb 2024.