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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Proprioception Exercise Group
Wand exercises and Proprioception exercises
Procedure: Proprioception exercises
Patients trained for proprioception exercises.
Procedure: Wand Exercise
Patients were educated with wand exercises.
Active Comparator: Proprioception exercises with Electromyographic Biofeedback
Wand exercises and Proprioception exercises with Electromyographic Biofeedback
Procedure: Wand Exercise
Patients were educated with wand exercises.
Procedure: Proprioception exercises with Electromyographic Biofeedback
Patients trained for Proprioception exercises with Electromyographic Biofeedback

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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