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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05402709
Other study ID # 2016-11/03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 26, 2016
Est. completion date June 25, 2017

Study information

Verified date November 2022
Source Yeditepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 25, 2017
Est. primary completion date February 8, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 60 Years
Eligibility 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.

Study Design


Intervention

Other:
Posterior mobilisation technique
Posterior mobilisation technique were applied
Posterior capsule stretching
Posterior capsule stretching were applied

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 weeks
Primary 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. 6 weeks
Primary 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. 6 weeks
Primary 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. 6 weeks
Primary 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. 6 weeks
Primary 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. 6 weeks
Primary 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. 6 weeks
Primary 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. 6 weeks
Primary 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. 6 weeks
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