Investigation of the Effectiveness of Core Stabilization Training in Patients With Subacromial Impingement Syndrome

Sponsor
Bandırma Onyedi Eylül University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05966298
Collaborator
(none)
48
1
2
17.1
2.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Core stabilization training
  • Other: Standart Rehabilitation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigation of The Efficacy of Core Stabilization Training in Patients With Subacromial Impingement Syndrome: A Randomized Controlled Study
Actual Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Core stabilization group

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 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.

Other: Standart Rehabilitation
This treatment includes shoulder exercises and conventional therapy (Infrared, ultrasound, TENS).

Other: Control group

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

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale [Baseline]

    It is used to assess the severity of pain. Pain severity with Visual Analogue Scale,(0-10) higher scores indicate more pain.

  2. Visual Analogue Scale [3 week]

    It is used to assess the severity of pain. Pain severity with Visual Analogue Scale,(0-10)higher scores indicate more pain.

  3. Visual Analogue Scale [6 week]

    It is used to assess the severity of pain. Pain severity with Visual Analogue Scale,(0-10)higher scores indicate more pain.

  4. Visual Analogue Scale [12 week]

    It is used to assess the severity of pain. Pain severity with Visual Analogue Scale,(0-10)higher scores indicate more pain.

  5. Digital goniometer [Baseline]

    It will be used for shoulder joint range of motion measurements.

  6. Digital goniometer [3 week]

    It will be used for shoulder joint range of motion measurements.

  7. Digital goniometer [6 week]

    It will be used for shoulder joint range of motion measurements.

  8. Digital goniometer [12 week]

    It will be used for shoulder joint range of motion measurements.

  9. Digital dynamometer [Baseline]

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

  10. Digital dynamometer [3 week]

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

  11. Digital dynamometer [6 week]

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

  12. Digital dynamometer [12 week]

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

  13. QuickDASH [Baseline]

    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).

  14. QuickDASH [3 week]

    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).

  15. QuickDASH [6 week]

    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).

  16. QuickDASH [12 week]

    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).

  17. Stabilizer pressure biofeedback device [Baseline]

    This device will be used to measure cervical and lumbar stabilizer muscle strength.

  18. Stabilizer pressure biofeedback device [3 week]

    This device will be used to measure cervical and lumbar stabilizer muscle strength.

  19. Stabilizer pressure biofeedback device [6 week]

    This device will be used to measure cervical and lumbar stabilizer muscle strength.

  20. Stabilizer pressure biofeedback device [12 week]

    This device will be used to measure cervical and lumbar stabilizer muscle strength.

  21. Modified "Biering-Sorensen" test [Baseline]

    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.

  22. Modified "Biering-Sorensen" test [3 week]

    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.

  23. Modified "Biering-Sorensen" test [6 week]

    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.

  24. Modified "Biering-Sorensen" test [12 week]

    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.

  25. Trunk flexors endurance test [Baseline]

    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.

  26. Trunk flexors endurance test [3 week]

    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.

  27. Trunk flexors endurance test [6 week]

    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.

  28. Trunk flexors endurance test [12 week]

    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.

  29. Lateral bridge test [Baseline]

    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.

  30. Lateral bridge test [3 week]

    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.

  31. Lateral bridge test [6 week]

    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.

  32. Lateral bridge test [12 week]

    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.

  33. Prone bridge test [Baseline]

    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.

  34. Prone bridge test [3 week]

    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.

  35. Prone bridge test [6 week]

    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.

  36. Prone bridge test [12 week]

    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.

  37. Modified "Push-ups" test [Baseline]

    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.

  38. Modified "Push-ups" test [3 week]

    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.

  39. Modified "Push-ups" test [6 week]

    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.

  40. Modified "Push-ups" test [12 week]

    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.

  41. Sit-ups test [Baseline]

    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.

  42. Sit-ups test [3 week]

    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.

  43. Sit-ups test [6 week]

    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.

  44. Sit-ups test [12 week]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eren Özen Bandırma Balıkesir Turkey 10200

Sponsors and Collaborators

  • Bandırma Onyedi Eylül University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eren Ozen, Principal Investigator, Bandırma Onyedi Eylül University
ClinicalTrials.gov Identifier:
NCT05966298
Other Study ID Numbers:
  • 2023-29
First Posted:
Jul 28, 2023
Last Update Posted:
Aug 2, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eren Ozen, Principal Investigator, Bandırma Onyedi Eylül University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2023