search
Back to results

Impact of Mulligan and Maitland Techniques on Rotator Cuff Lesions

Primary Purpose

Rotator Cuff Tears

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
conventional exercise program
Mulligan application
Maitland application
TENS
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rotator Cuff Tears focused on measuring Rotator cuff, Mulligan mobilization, Maitland mobilization, Exercise

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Control Group

Mulligan Group

Maitland Group

Arm Description

The individuals in this group will undergo a conventional exercise program.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 21, 2023
Last Updated
August 26, 2023
Sponsor
Istanbul Medipol University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05924360
Brief Title
Impact of Mulligan and Maitland Techniques on Rotator Cuff Lesions
Official Title
The Impact of Mulligan and Maitland Techniques on Pain, Functionality, Proprioception, and Quality of Life in Individuals With Rotator Cuff Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 23, 2023 (Actual)
Primary Completion Date
August 23, 2023 (Actual)
Study Completion Date
August 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
Rotator cuff, Mulligan mobilization, Maitland mobilization, Exercise

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Other
Arm Description
The individuals in this group will undergo a conventional exercise program.
Arm Title
Mulligan Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Maitland Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
conventional exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mulligan application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Maitland application
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
TENS application will be administered for 20 minutes at 100Hz
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
5 minutes
Title
Range of Motion
Description
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.
Time Frame
10 minutes
Title
Joint Postion Sense
Description
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.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder, and Hand Questionnaire
Description
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.
Time Frame
10 minutes
Title
Rotator cuff quality of life
Description
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.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burak Menek, PhD
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
State/Province
Bagcilar
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Mulligan and Maitland Techniques on Rotator Cuff Lesions

We'll reach out to this number within 24 hrs