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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05924360
Other study ID # E-10840098-772.02-1672
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 23, 2023
Est. completion date August 26, 2023

Study information

Verified date August 2023
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date August 26, 2023
Est. primary completion date August 23, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
conventional exercise program
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 application
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 application
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.
Device:
TENS
TENS application will be administered for 20 minutes at 100Hz

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul Bagcilar

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 minutes
Primary 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. 10 minutes
Primary 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. 5 minutes
Secondary 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. 10 minutes
Secondary 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. 10 minutes
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