Rotator Cuff TearsNCT05924360
Impact of Mulligan and Maitland Techniques on Rotator Cuff Lesions
A study testing conventional exercise program, Mulligan application and Maitland application in people with Rotator Cuff Tears, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The shoulder joint in the human body has a broader range of motion and opening compared to other joints, resulting in a multitude of potential problems. The rotator cuff lesion is one such issue. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- conventional exercise program, Mulligan application and Maitland application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2023to 26 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 30 and 70
- Not having undergone any previous shoulder surgery
- Being diagnosed with a rotator cuff lesion
- Not having any orthopedic or cardiac problems that could interfere with the study or evaluation
Who cannot join
- Having a pathology affecting the shoulder region
- Having undergone any shoulder surgery
- Individuals who are not cooperative or have mental problems
- Individuals with neurological, cardiac, and vascular problems
- Individuals who have participated in any physiotherapy program targeting the shoulder in the past 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Bagcilar
About this study
Official title: The Impact of Mulligan and Maitland Techniques on Pain, Functionality, Proprioception, and Quality of Life in Individuals With Rotator Cuff Lesions
The shoulder joint in the human body has a broader range of motion and opening compared to other joints, resulting in a multitude of potential problems. The rotator cuff lesion is one such issue. The rotator cuff is found in the subacromial space of the shoulder and results from the compression of the subacromial bursa and the long head of the M.biceps muscle between the humerus and the coracoacromial arch.
Upon reviewing the literature, therapeutic exercise and electrotherapy modalities are the most preferred and studied areas. Alongside these, we also observe the usage of Mulligan and Maitland techniques for the treatment of rotator cuff lesions.
Read more
The Mulligan technique was developed by Brian Mulligan in 1980, who lent his name to it. Also known as mobilization with movement, this technique is often applied to the body's distal joints. The Maitland mobilization technique is used to treat the relevant joint with specific methods, particularly focusing on pain and stiffness in the joint. The technique's application is graded from 1 to 4. Grade 1 is a small oscillation created without loading throughout the joint movement. Grade 2 is performed with a slightly more oscillation from the beginning of the movement. Grades 1 and 2 aim to restrict the pain stimulus going to the central nervous system by stimulating the mechanoreceptor in the joint, thereby reducing the sensation of pain.
Grade 3 is applied at a larger amplitude until a limitation is felt from the middle of the joint movement. Lastly, grade 4 is applied to the limited small amplitude until tissue resistance is felt. Grades 3 and 4 are used to alleviate joint stiffness by applying shorter oscillation stimuli to a shorter tissue. The results of the use of Mulligan and Maitland techniques have been demonstrated in different studies in the literature. However, as far as we know, no study in the literature compares these two techniques in individuals with rotator cuff lesions. Based on this gap in the literature, the purpose of this study is to investigate the effects of the Mulligan technique and the Maitland method on pain, range of joint motion, functionality, joint position sense, and quality of life in individuals with a rotator cuff problem.
Read the detailed description
The aim of this study is to examine the effectiveness of the Mulligan and Maitland techniques on pain, range of joint motion, functionality, joint position sense, and quality of life in individuals diagnosed with rotator cuff lesions. Individuals diagnosed with a rotator cuff lesion and admitted to Medipol University Hospital will be included in the study. Participants will be randomly divided into three groups. A conventional treatment program will be applied to individuals in all three groups five days a week for three weeks. The first group will only receive conventional treatment. The second group will receive conventional treatment plus the Mulligan technique. The third group will receive conventional treatment plus the Maitland technique. The conventional treatment program will be applied to all participants included in the study, consisting of wand, codman, active and passive stretching exercises, and TENS. This program will be administered to all patients five days a week. Wand exercises will be applied in the directions of flexion, abduction, extension, internal and external rotation, and will consist of 10 repetitions. Codman exercises will be applied in the directions of flexion, abduction, and circular, and will also consist of 10 repetitions. Active and passive stretching exercises will be applied in the directions of flexion, abduction, and external rotation, and will consist of 10 repetitions. TENS application will be administered for 20 minutes at 100Hz. All these exercises will be applied to the control, Mulligan, and Maitland groups.
Mulligan Group: The mobilization with movement technique, a part of Mulligan applications, will be performed twice a week in the directions of flexion, abduction, and external rotation.
Maitland Group: The Maitland application will be applied in the anterior-posterior, posterior-anterior, and caudal directions. The Maitland application will be administered at grades 2-3. Patients in this group will receive the application in five sets of 30 seconds, twice a week.
- Conditions
- Rotator Cuff Tears
- Being tested
- conventional exercise program, Mulligan application, Maitland application, TENS
- Keywords
- Rotator cuff, Mulligan mobilization, Maitland mobilization, Exercise
- Medical subject headings
- Rotator Cuff Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional exercise programOther
The conventional treatment program will be applied to all participants included in the study, consisting of wand, codman, active and passive stretching exercises. This program will be administered to all patients five days a week. Wand exercises will be applied in the directions of flexion, abduction, extension, internal and external rotation, and will consist of 10 repetitions. Codman exercises will be applied in the directions of flexion, abduction, and circular, and will also consist of 10 repetitions. Active and passive stretching exercises will be applied in the directions of flexion, abduction, and external rotation, and will consist of 10 repetitions.
Mulligan applicationOther
The mobilization with movement technique, a part of Mulligan applications, will be performed twice a week in the directions of flexion, abduction, and external rotation.
Maitland applicationOther
Maitland Group: The Maitland application will be applied in the anterior-posterior, posterior-anterior, and caudal directions. The Maitland application will be administered at grades 2-3. Patients in this group will receive the application in five sets of 30 seconds, twice a week.
TENSDevice
TENS application will be administered for 20 minutes at 100Hz
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | The individuals in this group will undergo a conventional exercise program. Receives: Other: conventional exercise program; Device: TENS |
| Mulligan Group | Experimental | In addition to the conventional treatment program, individuals in this group will receive the mobilization with movement technique in the directions of flexion, abduction, and external rotation, twice a week. Receives: Other: conventional exercise program; Other: Mulligan application |
| Maitland Group | Experimental | In addition to the conventional treatment program, The Maitland application will be administered in the anterior-posterior, posterior-anterior, and caudal directions. The Maitland application will be delivered at grades 2-3. Patients in this group will receive the application in five sets of 30 seconds, twice a week. Receives: Other: conventional exercise program; Other: Maitland application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale (VAS) The Visual Analog Scale is a commonly preferred evaluation method in clinical practice and literature studies for measuring pain intensity. Patients' pain levels are determined by numbering the range from 0 to 10. A score of 0 indicates no pain, while 10 represents the most intense pain felt.
Measured: 5 minutes
Range of Motion
Range of Joint Motion Evaluating the range of joint motion (ROM) is an objective method frequently used in both clinical settings and academic studies. The universal goniometer, used for assessing ROM, is the most preferred tool. In addition to determining the limit of joint movement, it is also used to provide clinicians with data on the effectiveness of the treatment.
Measured: 10 minutes
Joint Postion Sense
The joint position sense measurements of the individuals participating in the study will be evaluated using a goniometer. Participants will be asked to raise their shoulder to a certain degree, and then return it to the same angle with their eyes closed. The angular value formed when the eyes are closed and open will be recorded, and the difference between the shoulder angles will be calculated. The joint position sense will be applied at 30 and 60 degrees of flexion and abduction movements.
Measured: 5 minutes
Secondary outcomes (2)
Disabilities of the Arm, Shoulder, and Hand Questionnaire
The DASH (Disabilities of the Arm, Shoulder and Hand) outcome measure is a result of collaborative efforts by the American Academy of Orthopedic Surgeons and other organizations, designed to evaluate physical limitations and function in upper extremity lesions. The DASH questionnaire consists of three subsections. The first part includes 30 questions; 21 questions assess the difficulties encountered in the patient's daily life functions, 5 questions evaluate symptoms, and the remaining 4 questions assess social life, work, sleep, and self-confidence of the individual. The four-question section, also known as the Work Module (DASH-WM), which can be answered optionally, measures the difficulties the individual encounters in their work life.
Measured: 10 minutes
Rotator cuff quality of life
The quality of life scale developed by Hollinshead et al. is a measure that allows the participant to evaluate their own quality of life. Comprising a total of 34 questions, the scale consists of five sections evaluating disease symptoms and physical complaints (16 questions), work/occupation activities (4 questions), leisure activities (4 questions), lifestyle (5 questions), and social and emotional aspects (5 questions). Each question is answered with a 100 mm visual analog scale: "0" indicates the lowest and "100" the highest score. The total score is then represented as a percentage.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start23 Jun 2023
- Primary completion23 Aug 2023
- Study completion26 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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 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
- Burak Menek, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924360
- Sponsor's protocol ID
- E-10840098-772.02-1672
- Status last verified
- Aug 2023
- First submitted
- 21 Jun 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mulligan and Maitland Techniques on Pain, Functionality, Proprioception, and Quality of Life in Individuals With Rotator Cuff Lesions
- ClinicalTrials.gov ID
- NCT05924360
- Acronym / sponsor ID
- E-10840098-772.02-1672
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator cuff, Mulligan mobilization, Maitland mobilization, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 26 Aug 2023 (actual)
- First posted
- 29 Jun 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.
The shoulder joint in the human body has a broader range of motion and opening compared to other joints, resulting in a multitude of potential problems. The rotator cuff lesion is one such issue. The rotator cuff is found in the subacromial space of the shoulder and results from the compression of the subacromial bursa and the long head of the M.biceps muscle between the humerus and the coracoacromial arch.
Upon reviewing the literature, therapeutic exercise and electrotherapy modalities are the most preferred and studied areas. Alongside these, we also observe the usage of Mulligan and Maitland techniques for the treatment of rotator cuff lesions.
The Mulligan technique was developed by Brian Mulligan in 1980, who lent his name to it. Also known as mobilization with movement, this technique is often applied to the body's distal joints. The Maitland mobilization technique is used to treat the relevant joint with specific methods, particularly focusing on pain and stiffness in the joint. The technique's application is graded from 1 to 4. Grade 1 is a small oscillation created without loading throughout the joint movement. Grade 2 is performed with a slightly more oscillation from the beginning of the movement. Grades 1 and 2 aim to restrict the pain stimulus going to the central nervous system by stimulating the mechanoreceptor in the joint, thereby reducing the sensation of pain.
Grade 3 is applied at a larger amplitude until a limitation is felt from the middle of the joint movement. Lastly, grade 4 is applied to the limited small amplitude until tissue resistance is felt. Grades 3 and 4 are used to alleviate joint stiffness by applying shorter oscillation stimuli to a shorter tissue. The results of the use of Mulligan and Maitland techniques have been demonstrated in different studies in the literature. However, as far as we know, no study in the literature compares these two techniques in individuals with rotator cuff lesions. Based on this gap in the literature, the purpose of this study is to investigate the effects of the Mulligan technique and the Maitland method on pain, range of joint motion, functionality, joint position sense, and quality of life in individuals with a rotator cuff problem.
Detailed description
The aim of this study is to examine the effectiveness of the Mulligan and Maitland techniques on pain, range of joint motion, functionality, joint position sense, and quality of life in individuals diagnosed with rotator cuff lesions. Individuals diagnosed with a rotator cuff lesion and admitted to Medipol University Hospital will be included in the study. Participants will be randomly divided into three groups. A conventional treatment program will be applied to individuals in all three groups five days a week for three weeks. The first group will only receive conventional treatment. The second group will receive conventional treatment plus the Mulligan technique. The third group will receive conventional treatment plus the Maitland technique. The conventional treatment program will be applied to all participants included in the study, consisting of wand, codman, active and passive stretching exercises, and TENS. This program will be administered to all patients five days a week. Wand exercises will be applied in the directions of flexion, abduction, extension, internal and external rotation, and will consist of 10 repetitions. Codman exercises will be applied in the directions of flexion, abduction, and circular, and will also consist of 10 repetitions. Active and passive stretching exercises will be applied in the directions of flexion, abduction, and external rotation, and will consist of 10 repetitions. TENS application will be administered for 20 minutes at 100Hz. All these exercises will be applied to the control, Mulligan, and Maitland groups.
Mulligan Group: The mobilization with movement technique, a part of Mulligan applications, will be performed twice a week in the directions of flexion, abduction, and external rotation.
Maitland Group: The Maitland application will be applied in the anterior-posterior, posterior-anterior, and caudal directions. The Maitland application will be administered at grades 2-3. Patients in this group will receive the application in five sets of 30 seconds, twice a week.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: conventional exercise program, Device: TENSThe individuals in this group will undergo a conventional exercise program. |
| Mulligan Group | Experimental | Other: conventional exercise program, Other: Mulligan applicationIn addition to the conventional treatment program, individuals in this group will receive the mobilization with movement technique in the directions of flexion, abduction, and external rotation, twice a week. |
| Maitland Group | Experimental | Other: conventional exercise program, Other: Maitland applicationIn addition to the conventional treatment program, The Maitland application will be administered in the anterior-posterior, posterior-anterior, and caudal directions. The Maitland application will be delivered at grades 2-3. Patients in this group will receive the application in five sets of 30 seconds, twice a week. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being between the ages of 30 and 70
- Not having undergone any previous shoulder surgery
- Being diagnosed with a rotator cuff lesion
- Not having any orthopedic or cardiac problems that could interfere with the study or evaluation
Key exclusion criteria (5 listed)
- Having a pathology affecting the shoulder region
- Having undergone any shoulder surgery
- Individuals who are not cooperative or have mental problems
- Individuals with neurological, cardiac, and vascular problems
- Individuals who have participated in any physiotherapy program targeting the shoulder in the past 3 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 |
|---|---|---|
| conventional exercise programThe conventional treatment program will be applied to all participants included in the study, consisting of wand, codman, active and passive stretching exercises. This program will be administered to all patients five days a week. Wand exercises will be applied in the directions of flexion, abduction, extension, internal and external rotation, and will consist of 10 repetitions. Codman exercises will be applied in the directions of flexion, abduction, and circular, and will also consist of 10 repetitions. Active and passive stretching exercises will be applied in the directions of flexion, abduction, and external rotation, and will consist of 10 repetitions. | Other | Control Group, Maitland Group, Mulligan Group |
| Mulligan applicationThe mobilization with movement technique, a part of Mulligan applications, will be performed twice a week in the directions of flexion, abduction, and external rotation. | Other | Mulligan Group |
| Maitland applicationMaitland Group: The Maitland application will be applied in the anterior-posterior, posterior-anterior, and caudal directions. The Maitland application will be administered at grades 2-3. Patients in this group will receive the application in five sets of 30 seconds, twice a week. | Other | Maitland Group |
| TENSTENS application will be administered for 20 minutes at 100Hz | Device | Control Group |
Primary outcome
Visual Analog Scale
Time frame: 5 minutes
Visual Analog Scale (VAS) The Visual Analog Scale is a commonly preferred evaluation method in clinical practice and literature studies for measuring pain intensity. Patients' pain levels are determined by numbering the range from 0 to 10. A score of 0 indicates no pain, while 10 represents the most intense pain felt.
Range of Motion
Time frame: 10 minutes
Range of Joint Motion Evaluating the range of joint motion (ROM) is an objective method frequently used in both clinical settings and academic studies. The universal goniometer, used for assessing ROM, is the most preferred tool. In addition to determining the limit of joint movement, it is also used to provide clinicians with data on the effectiveness of the treatment.
Joint Postion Sense
Time frame: 5 minutes
The joint position sense measurements of the individuals participating in the study will be evaluated using a goniometer. Participants will be asked to raise their shoulder to a certain degree, and then return it to the same angle with their eyes closed. The angular value formed when the eyes are closed and open will be recorded, and the difference between the shoulder angles will be calculated. The joint position sense will be applied at 30 and 60 degrees of flexion and abduction movements.
2 secondary outcomes
Disabilities of the Arm, Shoulder, and Hand Questionnaire
Time frame: 10 minutes
Rotator cuff quality of life
Time frame: 10 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 29 Aug 2023.
- 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.
Burak Menek, PhD principal investigator
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 conventional exercise program, Mulligan application and Maitland application 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 29 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?
Visual Analog Scale (time frame: 5 minutes). The study lists 3 primary outcomes in all. 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 29 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.