Effectiveness of Posterior Capsule Stretching and Posterior Mobilization on Subacromial Impingement Syndrome
Primary Purpose
Subacromial Impingement Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Posterior mobilisation technique
Posterior capsule stretching
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring subacromial impingement syndrome, posterior capsule, mobilisation
Eligibility Criteria
Inclusion Criteria:
- To be between 30-60 years old
- Positive Neer, Hawkins-Kennedy impingement tests
- Painful arch and minimal limitation during active flexion and abduction movements in the glenohumeral joint area or proximal arm
- Symptoms lasting longer than 1 month
Exclusion Criteria:
- Adhesive capsulitis,
- Rotator cuff tears,
- Calcific tendinitis findings in radiology,
- Having a heart disease
- Presence of neurological diseases,
- Cognitive and mental problems that will affect understanding,
- Cervical radiculopathies,
- Presence of inflammatory joint diseases,
- Surgical intervention on the same shoulder in the last 12 months,
- To have had physical therapy on the same shoulder in the last 3 months,
- Presence of instability or previous dislocation history.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Posterior mobilization group
Posterior capsule stretching
Control group
Arm Description
Posterior mobilization, classical stretching, strengthening exercises were applied and home exercise program were given
Posterior capsule stretching, classical stretching, strengthening exercises were applied and home exercise program were given
No treatment was given, only assessment of posterior capsule tightness was applied.
Outcomes
Primary Outcome Measures
Assessment of Joint Range of Motion
Shoulder flexion, abduction, external and internal rotations were evaluated actively and passively using a classical goniometer (Santa Pharma 12 inch) while the patient was in the supine position. Measurements were made twice, before and at the end of the treatment (6th week), and the average value was taken bilaterally three times.
Assessment of Muscle Strength
"JTech Commander Power Track IITM" Myometer device was used for muscle strength evaluation. In the evaluation, shoulder flexion, extension, abduction, internal and external rotation movements were held with resistance for 3-5 seconds for each movement (according to the manual muscle test rules). Measurements were made twice, before and after the treatment. Each measurement was repeated bilaterally and three times, and the average values were taken and tested by the physiotherapist.
Assessment of Grip Strength
The grip strength of the hand was evaluated using the "JTech Commander Grip Track Hand Dynamometer". The patient was evaluated by the physiotherapist in a sitting position in a chair, with the shoulder to be tested in adduction and neutral rotation, the elbow in 90 degree flexion, and the forearm and wrist in neutral position. The patients were asked to squeeze the dynamometer as hard as possible. After a 30-second rest break between measurements, the next measurement was started. Measurements were made twice, before and after the treatment. Each measurement was repeated bilaterally and three times and evaluated by taking the average values.
Assessment of Pain
The pain intensity of the patients was evaluated with the Visual Analogue Scale (VAS) by the physiotherapist. The Visual Analogue Scale is a scale in which evaluation is made on a 10 cm line drawn on the horizontal plane with a maximum of 10 and a minimum of 0 points. The patient was asked to mark the severity of the pain he felt in his shoulder on this line, and the pain before and after the treatment was evaluated with this method.
American Shoulder and Elbow Surgeons Assessment Form
The American Shoulder and Elbow Surgeons Assessment Form (ASES) is a standard shoulder evaluation form that evaluates pain and function in the upper extremity, including objective and subjective parts, prepared by shoulder and elbow surgeons. The questionnaire consists of pain (VAS) and function (10 questions). The function section consists of a 4-point Likert scale for each question. The Turkish version of ASES was used in the study, the validity and reliability of which were made by Çelik et al. in 2012. The total score of the questionnaire completed by the patients before and after the treatment was evaluated out of 100.
Quick-DASH
The Arm, Shoulder and Hand Problems Questionnaire (Quick-DASH) is a scale that evaluates the disability and health status of the upper extremity, which can be filled by the individual alone. The questionnaire consists of 11 questions, each of which evaluates problems such as whether the patient has limitations in activities that require upper extremity functions in daily life activities, the effect of the current problem on the person's social activities, pain, tingling sensation and difficulty in sleeping, and a business model with 4 questions each, and sports that require high performance. The questions do not only address the shoulder area, but also cover the hand and arm. Scoring takes a value between 0-100 and a high score reflects more disability. In our study, we made use of the website while performing the Quick-DASH scoring. People with Subacromial Impingement Syndrome completed this questionnaire at the beginning and end of treatment.
Modified Constant-Murley Score (CMS)
Constant Murley Score (CMS), the first shoulder scoring system developed, was put into effect in 1987 by Constant and Murley. This questionnaire, which is used to evaluate various diseases of the shoulder; pain, activities of daily living, strength and range of motion are evaluated qualitatively and quantitatively. The CMS consists of pain (15 points), activities of daily living (20 points), movement (40 points), and strength (25 points) subscales. The difference of the modified CMS from the original CMS; While the VAS was used for the pain scale in the modified CMS, the pain was rated as "severe", "moderate", "mild", and "absent" in the original. Modified CMS is scored over 100 points. A higher score indicates higher quality of functionality. We also used the Turkish version of Modified Constant-Murley Score at the beginning and end of the treatment in our study.
Cornell Musculoskeletal Discomfort Questionnaire
The Cornell Musculoskeletal Discomfort Questionnaire is a data collection tool developed at the Human Factors and Ergonomics Laboratory at Cornell University and used to evaluate musculoskeletal problems. The Cornell Musculoskeletal Disorders Questionnaire includes questions such as the frequency and severity of musculoskeletal disorders and whether these disorders interfere with work, over 10 upper extremity body regions on 3 separated scales. In our study, the Turkish version of the Cornell Musculoskeletal Discomfort Questionnaire was used, and it was filled in by the patients at the beginning and end of the treatment.
Assessment of Posterior Capsule Tightness
The medial epicondyle of the tested arm is marked with a pencil and aligned with the subject's acromion perpendicular to the treatment table with the spine in a neutral position. By stabilizing the lateral border of the scapula while the shoulder is in the retracted position, scapular movement is restricted and the subject's humerus is positioned at 90° horizontal abduction, 0° rotation at the start of the test.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05402709
Brief Title
Effectiveness of Posterior Capsule Stretching and Posterior Mobilization on Subacromial Impingement Syndrome
Official Title
Comparison of the Effectiveness of Posterior Capsule Stretching and Posterior Mobilization on Subacromial Impingement Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 26, 2016 (Actual)
Primary Completion Date
February 8, 2017 (Actual)
Study Completion Date
June 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeditepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Subacromial Impingement Syndrome is one of the most common shoulder pathologies causing shoulder pain, functional disability and reduced quality of life. This study was designed to investigate the effectiveness of posterior capsule stretching and posterior mobilization on shoulder joint functions in Subacromial Impingement Syndrome.
Detailed Description
Subacromial Impingement Syndrome is one of the most common shoulder pathologies causing shoulder pain, functional disability, and reduced quality of life. This study investigated the effectiveness of posterior capsule stretching and posterior mobilization on shoulder joint functions in Subacromial Impingement Syndrome.
74 patients with SIS were enrolled, 58 were included, but 50 completed the study. Also, 30 healthy individuals were included and completed the study. The introductory characteristics of cases with the sociodemographic survey, pain intensity with VAS, upper extremity function with American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form and Modified Constant Murley Score, upper extremity disability and health situation with Quick Disability Arm, Shoulder and Hand Score, the evaluation of musculoskeletal symptoms with Cornell Musculoskeletal Discomfort Questionnaire, range of motion with a goniometer, shoulder muscle strength with myometer, grip strength with dynamometer and pinch meter and posterior capsule tightness with a tapeline. Individuals were divided into three different groups posterior mobilisation, posterior capsule, and control group. While participants included in the mobilization group were given classical stretching and strengthening and home exercise programs in addition to posterior mobilization, for the capsule stretching group, classical stretching and strengthening and home exercise program were given in addition to posterior capsule stretching exercise, and no exercise program was given to the control group and only posterior capsule tightness evaluation was applied.
In this study, while there was found a statistically significant difference between both groups in the Constant score and involved part External Rotation range of motion (p<0,05), a statistically significant difference was not observed in the evaluation of muscle strength, grip strength and posterior capsule tightness (p>0,05). In the participants who applied mobilization, the functional capacity of the shoulder joint was increased more than those of the capsule stretching.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
subacromial impingement syndrome, posterior capsule, mobilisation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals were randomly divided into 3 different groups as posterior mobilisation, posterior capsule stretching and control group
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posterior mobilization group
Arm Type
Active Comparator
Arm Description
Posterior mobilization, classical stretching, strengthening exercises were applied and home exercise program were given
Arm Title
Posterior capsule stretching
Arm Type
Active Comparator
Arm Description
Posterior capsule stretching, classical stretching, strengthening exercises were applied and home exercise program were given
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No treatment was given, only assessment of posterior capsule tightness was applied.
Intervention Type
Other
Intervention Name(s)
Posterior mobilisation technique
Intervention Description
Posterior mobilisation technique were applied
Intervention Type
Other
Intervention Name(s)
Posterior capsule stretching
Intervention Description
Posterior capsule stretching were applied
Primary Outcome Measure Information:
Title
Assessment of Joint Range of Motion
Description
Shoulder flexion, abduction, external and internal rotations were evaluated actively and passively using a classical goniometer (Santa Pharma 12 inch) while the patient was in the supine position. Measurements were made twice, before and at the end of the treatment (6th week), and the average value was taken bilaterally three times.
Time Frame
6 weeks
Title
Assessment of Muscle Strength
Description
"JTech Commander Power Track IITM" Myometer device was used for muscle strength evaluation. In the evaluation, shoulder flexion, extension, abduction, internal and external rotation movements were held with resistance for 3-5 seconds for each movement (according to the manual muscle test rules). Measurements were made twice, before and after the treatment. Each measurement was repeated bilaterally and three times, and the average values were taken and tested by the physiotherapist.
Time Frame
6 weeks
Title
Assessment of Grip Strength
Description
The grip strength of the hand was evaluated using the "JTech Commander Grip Track Hand Dynamometer". The patient was evaluated by the physiotherapist in a sitting position in a chair, with the shoulder to be tested in adduction and neutral rotation, the elbow in 90 degree flexion, and the forearm and wrist in neutral position. The patients were asked to squeeze the dynamometer as hard as possible. After a 30-second rest break between measurements, the next measurement was started. Measurements were made twice, before and after the treatment. Each measurement was repeated bilaterally and three times and evaluated by taking the average values.
Time Frame
6 weeks
Title
Assessment of Pain
Description
The pain intensity of the patients was evaluated with the Visual Analogue Scale (VAS) by the physiotherapist. The Visual Analogue Scale is a scale in which evaluation is made on a 10 cm line drawn on the horizontal plane with a maximum of 10 and a minimum of 0 points. The patient was asked to mark the severity of the pain he felt in his shoulder on this line, and the pain before and after the treatment was evaluated with this method.
Time Frame
6 weeks
Title
American Shoulder and Elbow Surgeons Assessment Form
Description
The American Shoulder and Elbow Surgeons Assessment Form (ASES) is a standard shoulder evaluation form that evaluates pain and function in the upper extremity, including objective and subjective parts, prepared by shoulder and elbow surgeons. The questionnaire consists of pain (VAS) and function (10 questions). The function section consists of a 4-point Likert scale for each question. The Turkish version of ASES was used in the study, the validity and reliability of which were made by Çelik et al. in 2012. The total score of the questionnaire completed by the patients before and after the treatment was evaluated out of 100.
Time Frame
6 weeks
Title
Quick-DASH
Description
The Arm, Shoulder and Hand Problems Questionnaire (Quick-DASH) is a scale that evaluates the disability and health status of the upper extremity, which can be filled by the individual alone. The questionnaire consists of 11 questions, each of which evaluates problems such as whether the patient has limitations in activities that require upper extremity functions in daily life activities, the effect of the current problem on the person's social activities, pain, tingling sensation and difficulty in sleeping, and a business model with 4 questions each, and sports that require high performance. The questions do not only address the shoulder area, but also cover the hand and arm. Scoring takes a value between 0-100 and a high score reflects more disability. In our study, we made use of the website while performing the Quick-DASH scoring. People with Subacromial Impingement Syndrome completed this questionnaire at the beginning and end of treatment.
Time Frame
6 weeks
Title
Modified Constant-Murley Score (CMS)
Description
Constant Murley Score (CMS), the first shoulder scoring system developed, was put into effect in 1987 by Constant and Murley. This questionnaire, which is used to evaluate various diseases of the shoulder; pain, activities of daily living, strength and range of motion are evaluated qualitatively and quantitatively. The CMS consists of pain (15 points), activities of daily living (20 points), movement (40 points), and strength (25 points) subscales. The difference of the modified CMS from the original CMS; While the VAS was used for the pain scale in the modified CMS, the pain was rated as "severe", "moderate", "mild", and "absent" in the original. Modified CMS is scored over 100 points. A higher score indicates higher quality of functionality. We also used the Turkish version of Modified Constant-Murley Score at the beginning and end of the treatment in our study.
Time Frame
6 weeks
Title
Cornell Musculoskeletal Discomfort Questionnaire
Description
The Cornell Musculoskeletal Discomfort Questionnaire is a data collection tool developed at the Human Factors and Ergonomics Laboratory at Cornell University and used to evaluate musculoskeletal problems. The Cornell Musculoskeletal Disorders Questionnaire includes questions such as the frequency and severity of musculoskeletal disorders and whether these disorders interfere with work, over 10 upper extremity body regions on 3 separated scales. In our study, the Turkish version of the Cornell Musculoskeletal Discomfort Questionnaire was used, and it was filled in by the patients at the beginning and end of the treatment.
Time Frame
6 weeks
Title
Assessment of Posterior Capsule Tightness
Description
The medial epicondyle of the tested arm is marked with a pencil and aligned with the subject's acromion perpendicular to the treatment table with the spine in a neutral position. By stabilizing the lateral border of the scapula while the shoulder is in the retracted position, scapular movement is restricted and the subject's humerus is positioned at 90° horizontal abduction, 0° rotation at the start of the test.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
To be between 30-60 years old
Positive Neer, Hawkins-Kennedy impingement tests
Painful arch and minimal limitation during active flexion and abduction movements in the glenohumeral joint area or proximal arm
Symptoms lasting longer than 1 month
Exclusion Criteria:
Adhesive capsulitis,
Rotator cuff tears,
Calcific tendinitis findings in radiology,
Having a heart disease
Presence of neurological diseases,
Cognitive and mental problems that will affect understanding,
Cervical radiculopathies,
Presence of inflammatory joint diseases,
Surgical intervention on the same shoulder in the last 12 months,
To have had physical therapy on the same shoulder in the last 3 months,
Presence of instability or previous dislocation history.
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Posterior Capsule Stretching and Posterior Mobilization on Subacromial Impingement Syndrome
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