NCT05966298

Brief Summary

Subacromial Impingement Syndrome (SIS) 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 SIS. For this reason, this study was planned to examine the effects of core stabilization training applied in addition to conventional treatment in patients with SIS on pain, range of motion, shoulder muscles strenght and core stability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

July 13, 2023

Last Update Submit

August 21, 2025

Conditions

Keywords

Subacromial Impingement Syndromecore stabilization trainingcore stabilitypainrange of motionupper extremity functionSubacromial ImpingementImpingementCore Stabilization Exercisescore stability exercises

Outcome Measures

Primary Outcomes (40)

  • 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

  • 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

  • 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

  • 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

  • Digital dynamometer

    It will be used to measure the strength of the shoulder muscles.

    Baseline

  • Digital dynamometer

    It will be used to measure the strength of the shoulder muscles.

    3 week

  • Digital dynamometer

    It will be used to measure the strength of the shoulder muscles.

    6 week

  • Digital dynamometer

    It will be used to measure the strength of the shoulder muscles.

    12 week

  • 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

  • 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

  • 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

  • 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

  • Stabilizer pressure biofeedback device

    This device will be used to measure deep cervical flexor muscles endurance.

    Baseline

  • Stabilizer pressure biofeedback device

    This device will be used to measure deep cervical flexor muscles endurance.

    3 week

  • Stabilizer pressure biofeedback device

    This device will be used to measure deep cervical flexor muscles endurance.

    6 week

  • Stabilizer pressure biofeedback device

    This device will be used to measure deep cervical flexor muscles endurance.

    12 week

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Core stabilization group

EXPERIMENTAL

Individuals included in this group will receive 20 minutes of core stabilization training in addition to 40 minutes of standard rehabilitation. Patients will be trained 5 days a week for first 3 weeks(standart rehabilitation + core stabilization training) then will be trained 3 days a week on 4-6 week (only core stabilization training). The next 6 weeks will be given a home exercise program including shoulder exercises and core stabilization training.

Other: Core stabilization trainingOther: Standart Rehabilitation

Control group

OTHER

Individuals included in this group will receive only 40 minutes of standard rehabilitation. Patients will be trained 5 days a week for first 3 weeks(only standart rehabilitation). The next 9 weeks will be given a home exercise program including shoulder exercises.

Other: Standart Rehabilitation

Interventions

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.

Core stabilization group

This treatment includes shoulder exercises and conventional therapy (Infrared, TENS).

Control groupCore stabilization group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eren Özen

Bandırma, Balıkesir, 10200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromePain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 28, 2023

Study Start

August 1, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations