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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05966298
Other study ID # 2023-29
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date December 1, 2024

Study information

Verified date July 2023
Source Bandirma Onyedi Eylül University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Subacromial Impingement Syndrome (SSS) is one of the most common shoulder problems. The core region is considered a kinetic link that facilitates the transfer of torque and angular momentum between the upper and lower extremities during body movements. The decrease in core stabilization affects both trunk control and the quality of extremity movements depending on the kinetic chain in the body. The improvement in core stabilization balances the load transfer between the trunk and the extremities and reduces the asymmetry between the extremities. Core stabilization training should be included in rehabilitation programs as core stabilization is adversely affected in patients with CNS. For this reason, this study was planned to examine the effects of core stabilization training applied in addition to conventional treatment in patients with CNS on pain, range of motion, upper extremity function and core stability.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date December 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Being diagnosed with subacromial impingement syndrome, - Being between the ages of 18-65, - Not having received medical treatment, - Not having received a shoulder-related physiotherapy program in the last 1 year, - Not having undergone any shoulder-related surgery, - Being able to read and understand Turkish Exclusion Criteria: - Neurological deficits of the upper extremity and the presence of another orthopedic disease, rheumatic and congenital disease other than CNS - Presence of mental problems, - To have received corticosteroid treatment in the last year, - Having cardiovascular and systemic diseases that prevent work, - Pregnancy, - Those with communication problems

Study Design


Intervention

Other:
Core stabilization training
First, while focusing on the activation methods of deep cervical flexor, transversus abdominus and multifidus muscles in individuals; In the next stages, exercises will be performed that will preserve the contraction of the deep cervical flexor, transversus abdominus and multifidus muscles and activate the other muscles of the body.
Standart Rehabilitation
This treatment includes shoulder exercises and conventional therapy (Infrared, ultrasound, TENS).

Locations

Country Name City State
Turkey Eren Özen Bandirma Balikesir

Sponsors (1)

Lead Sponsor Collaborator
Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale It is used to assess the severity of pain. Pain severity with Visual Analogue Scale,(0-10) higher scores indicate more pain. Baseline
Primary Visual Analogue Scale It is used to assess the severity of pain. Pain severity with Visual Analogue Scale,(0-10)higher scores indicate more pain. 3 week
Primary Visual Analogue Scale It is used to assess the severity of pain. Pain severity with Visual Analogue Scale,(0-10)higher scores indicate more pain. 6 week
Primary Visual Analogue Scale It is used to assess the severity of pain. Pain severity with Visual Analogue Scale,(0-10)higher scores indicate more pain. 12 week
Primary Digital goniometer It will be used for shoulder joint range of motion measurements. Baseline
Primary Digital goniometer It will be used for shoulder joint range of motion measurements. 3 week
Primary Digital goniometer It will be used for shoulder joint range of motion measurements. 6 week
Primary Digital goniometer It will be used for shoulder joint range of motion measurements. 12 week
Primary Digital dynamometer It will be used to measure the strength of the shoulder muscles. Baseline
Primary Digital dynamometer It will be used to measure the strength of the shoulder muscles. 3 week
Primary Digital dynamometer It will be used to measure the strength of the shoulder muscles. 6 week
Primary Digital dynamometer It will be used to measure the strength of the shoulder muscles. 12 week
Primary QuickDASH It is a questionnaire that evaluates disorders in all upper extremity functions. The QuickDASH is an abbreviated 11-question subset from the original Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. The questionnaire's answers are scored on a 1-5 points scale that is then transformed to result in a score that ranges from 0 (indicating least disability) to 100 (indicating most disability). Baseline
Primary QuickDASH It is a questionnaire that evaluates disorders in all upper extremity functions. The QuickDASH is an abbreviated 11-question subset from the original Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. The questionnaire's answers are scored on a 1-5 points scale that is then transformed to result in a score that ranges from 0 (indicating least disability) to 100 (indicating most disability). 3 week
Primary QuickDASH It is a questionnaire that evaluates disorders in all upper extremity functions. The QuickDASH is an abbreviated 11-question subset from the original Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. The questionnaire's answers are scored on a 1-5 points scale that is then transformed to result in a score that ranges from 0 (indicating least disability) to 100 (indicating most disability). 6 week
Primary QuickDASH It is a questionnaire that evaluates disorders in all upper extremity functions.The QuickDASH is an abbreviated 11-question subset from the original Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. The questionnaire's answers are scored on a 1-5 points scale that is then transformed to result in a score that ranges from 0 (indicating least disability) to 100 (indicating most disability). 12 week
Primary Stabilizer pressure biofeedback device This device will be used to measure cervical and lumbar stabilizer muscle strength. Baseline
Primary Stabilizer pressure biofeedback device This device will be used to measure cervical and lumbar stabilizer muscle strength. 3 week
Primary Stabilizer pressure biofeedback device This device will be used to measure cervical and lumbar stabilizer muscle strength. 6 week
Primary Stabilizer pressure biofeedback device This device will be used to measure cervical and lumbar stabilizer muscle strength. 12 week
Primary Modified "Biering-Sorensen" test Test will be applied to assess the endurance of the core muscles. The subjects are positioned in the prone position. The subjects are asked to extend their upper body straight forward from the edge of the table. How long the patient was able to perform the test was recorded in seconds. Baseline
Primary Modified "Biering-Sorensen" test Test will be applied to assess the endurance of the core muscles. The subjects are positioned in the prone position. The subjects are asked to extend their upper body straight forward from the edge of the table. How long the patient was able to perform the test was recorded in seconds. 3 week
Primary Modified "Biering-Sorensen" test Test will be applied to assess the endurance of the core muscles. The subjects are positioned in the prone position. The subjects are asked to extend their upper body straight forward from the edge of the table. How long the patient was able to perform the test was recorded in seconds. 6 week
Primary Modified "Biering-Sorensen" test Test will be applied to assess the endurance of the core muscles. The subjects are positioned in the prone position. The subjects are asked to extend their upper body straight forward from the edge of the table. How long the patient was able to perform the test was recorded in seconds. 12 week
Primary Trunk flexors endurance test Test will be applied to assess the endurance of the core muscles. Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion. The evaluator fixes the feet on the ground by supporting them from the toes. When the 60º trunk flexion is broken, the test will be terminated. How long the patient was able to perform the test was recorded in seconds. Baseline
Primary Trunk flexors endurance test Test will be applied to assess the endurance of the core muscles. Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion. The evaluator fixes the feet on the ground by supporting them from the toes. When the 60º trunk flexion is broken, the test will be terminated. How long the patient was able to perform the test was recorded in seconds. 3 week
Primary Trunk flexors endurance test Test will be applied to assess the endurance of the core muscles. Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion. The evaluator fixes the feet on the ground by supporting them from the toes. When the 60º trunk flexion is broken, the test will be terminated. How long the patient was able to perform the test was recorded in seconds. 6 week
Primary Trunk flexors endurance test Test will be applied to assess the endurance of the core muscles. Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion. The evaluator fixes the feet on the ground by supporting them from the toes. When the 60º trunk flexion is broken, the test will be terminated. How long the patient was able to perform the test was recorded in seconds. 12 week
Primary Lateral bridge test Test will be applied to assess the endurance of the core muscles. The subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position(both sides). How long the patient was able to perform the test was recorded in seconds. Baseline
Primary Lateral bridge test Test will be applied to assess the endurance of the core muscles. The subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position(both sides). How long the patient was able to perform the test was recorded in seconds. 3 week
Primary Lateral bridge test Test will be applied to assess the endurance of the core muscles. The subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position(both sides). How long the patient was able to perform the test was recorded in seconds. 6 week
Primary Lateral bridge test Test will be applied to assess the endurance of the core muscles. The subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position(both sides). How long the patient was able to perform the test was recorded in seconds. 12 week
Primary Prone bridge test Test will be applied to assess the endurance of the core muscles. The subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight. The tests end when the subjects break the test positions. How long the patient was able to perform the test was recorded in seconds. Baseline
Primary Prone bridge test Test will be applied to assess the endurance of the core muscles. The subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight. The tests end when the subjects break the test positions. How long the patient was able to perform the test was recorded in seconds. 3 week
Primary Prone bridge test Test will be applied to assess the endurance of the core muscles. The subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight. The tests end when the subjects break the test positions. How long the patient was able to perform the test was recorded in seconds. 6 week
Primary Prone bridge test Test will be applied to assess the endurance of the core muscles. The subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight. The tests end when the subjects break the test positions. How long the patient was able to perform the test was recorded in seconds. 12 week
Primary Modified "Push-ups" test Test will be applied to assess the strength of the core muscles. The subjects are positioned in the prone position with their hands shoulder-width apart and elbows and knees flexed. The subjects were asked to raise their body up by extending their elbows. The number of times the patient repeats the movement in 30 seconds is recorded. Baseline
Primary Modified "Push-ups" test Test will be applied to assess the strength of the core muscles. The subjects are positioned in the prone position with their hands shoulder-width apart and elbows and knees flexed. The subjects were asked to raise their body up by extending their elbows. The number of times the patient repeats the movement in 30 seconds is recorded. 3 week
Primary Modified "Push-ups" test Test will be applied to assess the strength of the core muscles. The subjects are positioned in the prone position with their hands shoulder-width apart and elbows and knees flexed. The subjects were asked to raise their body up by extending their elbows. The number of times the patient repeats the movement in 30 seconds is recorded. 6 week
Primary Modified "Push-ups" test Test will be applied to assess the strength of the core muscles. The subjects are positioned in the prone position with their hands shoulder-width apart and elbows and knees flexed. The subjects were asked to raise their body up by extending their elbows. The number of times the patient repeats the movement in 30 seconds is recorded. 12 week
Primary Sit-ups test Test will be applied to assess the strength of the core muscles. The subjects are asked to flex the trunk while the knees are flexed in the supine position. During the test, the feet of subjects are stabilized. The number of times the patient repeats the movement in 30 seconds is recorded. Baseline
Primary Sit-ups test Test will be applied to assess the strength of the core muscles. The subjects are asked to flex the trunk while the knees are flexed in the supine position. During the test, the feet of subjects are stabilized. The number of times the patient repeats the movement in 30 seconds is recorded. 3 week
Primary Sit-ups test Test will be applied to assess the strength of the core muscles. The subjects are asked to flex the trunk while the knees are flexed in the supine position. During the test, the feet of subjects are stabilized. The number of times the patient repeats the movement in 30 seconds is recorded. 6 week
Primary Sit-ups test Test will be applied to assess the strength of the core muscles. The subjects are asked to flex the trunk while the knees are flexed in the supine position. During the test, the feet of subjects are stabilized. The number of times the patient repeats the movement in 30 seconds is recorded. 12 week
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