- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06156475
The Physiotherapy Approaches in Patients With Subacromial Impingement Syndrome
December 5, 2023 updated by: Ebru Kaya Mutlu, PT, Istanbul University - Cerrahpasa (IUC)
The Effect of Electromyographic Biofeedback and Proprioception Exercises on Pain and Functionality in Patients With Subacromial Impingement Syndrome: A Randomized Controlled Study
The aim of this study is to investigate the effectiveness of Electromyographic Biofeedback with proprioception exercises on pain, range of motion, muscle strength, proprioception and functionality in patients with subacromial impingement syndrome.
Study Overview
Status
Completed
Conditions
Detailed Description
This study is planned as a prospective, randomized clinical study.
Patients with subacromial impingement syndrome who volunteered to participate in the study, met the inclusion criteria, and signed the consent form were randomly assigned to the proprioception exercise group and the proprioception exercise with electromyographic biofeedback group.
Demographic and clinical data of the patients were recorded.
Shoulder function with Disabilities of the Arm, Shoulder and Hand scale, pain with VAS, painless active shoulder flexion, abduction, and external-internal rotation with goniometer, muscle strength with Manual Muscle Tester, proprioception (55°-90°- 125° angles of flexion and abduction, and angular deviations) with the Laser-pointer assisted angle reproduction test were evaluated, and patient satisfaction was evaluated with The Global Rating of Change Scale.
After the initial evaluations were completed, only proprioception exercises and proprioception exercises with EMG-BF were applied 2 days a week for 8 weeks.
Additionally, both groups were given Want exercises.
Study Type
Interventional
Enrollment (Actual)
48
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
-
-
Florya
-
Istanbul, Florya, Turkey
- Istanbul Aydin University
-
-
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
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being diagnosed with subacromial impingement syndrome,
- Being between the ages of 18 and 65,
- Not having received medical treatment,
- Not having received a shoulder-related physiotherapy program in the last year,
- Not having had any shoulder-related surgery,
Exclusion Criteria:
- Neurological deficits of the upper extremity and the presence of another orthopedic disorder, rheumatic or congenital disease other than subacromial impingement syndrome,
- Presence of mental problem,
- Having received corticosteroid treatment in the last year,
- Upper extremity fracture,
- Acute cervical pathology,
- Having cardiovascular and systemic diseases that prevent working,
- Pregnancy,
- Those with communication problems.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Proprioception Exercise Group
Wand exercises and Proprioception exercises
|
Patients trained for proprioception exercises.
Patients were educated with wand exercises.
|
|
Active Comparator: Proprioception exercises with Electromyographic Biofeedback
Wand exercises and Proprioception exercises with Electromyographic Biofeedback
|
Patients were educated with wand exercises.
Patients trained for Proprioception exercises with Electromyographic Biofeedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disabilities of the Arm, Shoulder and Hand scale
Time Frame: 8 weeks
|
The Disabilities of the Arm, Shoulder and Hand scale was used to measure shoulder function.
The Disabilities of the Arm, Shoulder and Hand scale consists of 30 items.
The total score that can be obtained from items scored between 1-5 varies between 0-100.
An increase in the score indicates a decrease in function.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Joint range of motion
Time Frame: 8 weeks
|
Active shoulder flexion, abduction, and external-internal rotation range of motion was measured with goniometer.
|
8 weeks
|
|
Muscle strength
Time Frame: 8 weeks
|
Shoulder flexion, abduction, and external-internal rotator muscle strength was measured with manual muscle tester.
|
8 weeks
|
|
Proprioception
Time Frame: 8 weeks
|
To evaluate joint position sense, laser pointer-assisted angle reproduction test was applied for measurements at 55°-90°-125° flexion and abduction angles.
|
8 weeks
|
|
Visual analogue scale
Time Frame: 8 weeks
|
The severity of pain was measured Visual analogue scale.
ccording to this scale, patients rated their pain between 0 and 10.
As the score increases, the pain increases.
|
8 weeks
|
|
Patient satisfaction
Time Frame: 8 weeks
|
The amount of improvement or deterioration in patients was assessed with the "Global Rating Change Scale".This scale is scored according to a 7-point Likert type (-3: much worse, -2: worse, -1: slightly worse, 0: the same, 1: slightly better, 2: quite better, 3: much better).
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ebru Kaya Mutlu, Professor, Bandırma Onyedi Eylül University
- Study Chair: Buse Aydin, M.Sc., Istabul Aydin University
- Study Chair: Yasemin Karaaslan, Asst. Prof., Mustafa Kemal University
- Study Chair: Hanifegül Taskiran, Professor, Istanbul Aydın University
- Study Chair: Nezih Ziroglu, MD, Acıbadem Mehmet Ali Aydınlar 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)
May 1, 2021
Primary Completion (Actual)
August 1, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
November 27, 2023
First Submitted That Met QC Criteria
November 27, 2023
First Posted (Actual)
December 5, 2023
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISTANBUL AYDIN UNIVERSITY
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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