- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06531889
Core Stabilization Exercises on Shoulder Impingement Syndrome
July 30, 2024 updated by: Nuray Alaca, Acibadem University
Core Stabilization Exercises in Shoulder Impingement Syndrome: A Preliminary Retrospective Study
The objective of this retrospective study was to look into the effects of core stabilization exercises applied in conjunction with classic physiotherapy program on pain, muscle strength, disability, and posture in SIS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İ̇stanbul, Turkey, +90
- Yeditepe University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients between the ages of 35 and 60 who were diagnosed by a Physical Therapy and Rehabilitation doctor with at least ten years of experience, whose SIS was confirmed by MRI, and who had shoulder complaints for at least three months, patients with positive signs, a positive Hawkins-Kennedy test, significant loss of active and passive shoulder movements or painful range of motion (ROM), and patients whose treatment and evaluation methods were appropriate for the study design were enrolled in the study
Exclusion Criteria:
- Patients who had upper extremity surgery, patients with a history of shoulder trauma and corticosteroid application to the shoulder region in the previous year, a history of shoulder dislocation, infection, tumor, adhesive capsulitis, reflex sympathetic dystrophy, congenital anomaly, rheumatic disease, and chronic severe systemic disease, as well as professional athletes and patients whose evaluations were missing in the previous month were excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: classical physiotherapy program
The group in classical physiotherapy program; n=25 (3 days per week for six weeks)
|
Classical physiotherapy program=Classical physiotherapy program included transcutaneous electrical nerve stimulation, infrared radiation for 15 min, continuous ultrasound for 5 min and home exercise program.
For active assistive shoulder range of motion (ROM), home exercises included the Codman exercise, flexion exercise at the ladder, and the Wand exercise, as well as some strengthening and stretching exercises performed at the pain limit with 10 repetitions twice a day (six weeks)
|
|
Experimental: core stabilization group
The group in which core stabilization was also performed in addition to classical physiotherapy program; n=25 (3 days per week for 6 weeks)
|
Classical physiotherapy program=Classical physiotherapy program included transcutaneous electrical nerve stimulation, infrared radiation for 15 min, continuous ultrasound for 5 min and home exercise program.
For active assistive shoulder range of motion (ROM), home exercises included the Codman exercise, flexion exercise at the ladder, and the Wand exercise, as well as some strengthening and stretching exercises performed at the pain limit with 10 repetitions twice a day (six weeks)
The interventions of the core exercise were applied when the patient lay on his/her back with his/her knees at flexion.
The number of repeats for each exercise was five, and these exercises were done 3 times a week for 6 weeks with the same physiotherapist.
The further steps in the exercises were extended according to the activation duration of the core muscles, and this extension was elongated 5 s
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Numerical Rating Scale (NPRS-11)
Time Frame: Change from baseline pain score at 6th week
|
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain.
It is the most commonly used unidimensional pain scale.
The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum.
The higher the score, the more severe the pain.
|
Change from baseline pain score at 6th week
|
|
New York Posture Rating Method to determine their postures
Time Frame: Change from baseline pain score at 6th week
|
The rating chart is used to assess 13 areas of the body, based on the assumption that posture is the alignment of the body and its segments.
13 regions (head, neck, shoulder, scapula, upper thoracic, waist, rips, abdomen, hips, knees, legs, feet and toes) are assessed in two different positions (lateral and posterior).
A score is allocated to each area according to the position: 5 points to the correct position; 3 points for a slight deviation, and 1 point for a pronounced deviation.
Total score is between 18-90 points.
higher the points better the postural alignment
|
Change from baseline pain score at 6th week
|
|
Shoulder pain and disability index
Time Frame: Change from baseline score of The Shoulder Pain and Disability Index at 6th week
|
The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting.
The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability between 0 to 100, with a higher value indicating worse condition.
|
Change from baseline score of The Shoulder Pain and Disability Index at 6th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder mobility on the Shoulder Range of Motion
Time Frame: Change from baseline range of motion at 6th week
|
Shoulder ROM was measured in six directions (Flexion, Extension, Abduction, Adduction, Right rotation, Left rotation) with goniometer.
|
Change from baseline range of motion at 6th week
|
|
Core muscle strength test
Time Frame: Change from baseline strenght score at 6th week
|
The level of difficulty was raised from stage 1 to stage 5. high values are indicative of positive progress
|
Change from baseline strenght score at 6th week
|
|
Endurance of Core Muscles
Time Frame: Change from baseline endurance score at 6th week
|
Each test was repeated three times, and the average of the measurements was used.
The Biering-Sørensen test measures how many seconds the participant can keep the unsupported upper part of the body in a horizontal position.high
values are indicative of positive progress
|
Change from baseline endurance score at 6th week
|
|
Manual muscle test
Time Frame: Change from baseline manual muscle testing score at 6th week
|
The lowest value is zero and the highest value is 5. high values are indicative of positive progress
|
Change from baseline manual muscle testing score at 6th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Nuray ALACA, Acibadem University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
August 30, 2019
Study Registration Dates
First Submitted
December 15, 2023
First Submitted That Met QC Criteria
July 30, 2024
First Posted (Actual)
August 1, 2024
Study Record Updates
Last Update Posted (Actual)
August 1, 2024
Last Update Submitted That Met QC Criteria
July 30, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 37068608-6100-15-1757
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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