Effects of Exercise Trainings on Pain, Function and AHD in Patients With SPS

January 20, 2022 updated by: Leyla Eraslan, Hacettepe University

Utilizing Scapula Retraction Exercises With or Without Glenohumeral Rotational Exercises With a Gradual Progression: A Double-Blind Randomized Controlled Trial for Subacromial Pain Syndrome

Abnormal reduction of the AHD has been considered as one of the possible mechanisms in the aetiology of subacromial pain syndrome. Maintenance of the AHD is crucial for prevention and rehabilitation of rotator cuff related disorders.

The development of a rehabilitation treatment plan is based in part on the assessment of scapular motion and muscle deficits in patients with shoulder pain. Rehabilitation should be based on the identified impairments.

The aim of this study is to investigate the effect of utilizing scapula retraction exercises with or without glenohumeral rotational exercises at gradual shoulder elevation angles into a scapular stabilization program on functionality, pain and AHD in patients with SPS and compare with health population.

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

Coordinated motion between the humerus and scapula is required for pain-free arm movement. Rotator cuff and scapulothoracic muscles dynamically control the subacromial space or acromiohumeral distance (AHD).Scapulothoracic muscles need to provide stability and control in a synchronized fashion to facilitate normal scapulohumeral movement. Scapular upward rotation and posterior tilt is essential to maintain the AHD.Therefore, the force couple function of the rotator cuff muscles play an critical role in opposing the superior migration force that is generated by deltoid muscle and, to maintenance the subacromial space.

Abnormal reduction of the AHD has been considered as one of the possible mechanisms in the aetiology of subacromial impingement syndrome. Maintenance of the AHD is crucial for prevention and rehabilitation of rotator cuff related disorders.

The development of a rehabilitation treatment plan is based in part on the assessment of scapular motion and muscle deficits in patients with shoulder pain. Rehabilitation should be based on the identified impairments.

he aim of this study is to investigate the effect of utilizing scapula retraction exercises with or without glenohumeral rotational exercises at gradual shoulder elevation angles into a scapular stabilization program on functionality, pain and AHD in patients with SPS and compare with health population.

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.
49

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
      • Ankara, Turkey, 06100
        • Hacettepe University, Faculty of Health Sciences, Dept. of Physiotherapy and Rehabilitation

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

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • painful arc of movement during flexion or abduction;
  • positive Neer or Kennedy-Hawkins impingement signs
  • pain on resisted lateral rotation, abduction or empty can test.

Exclusion Criteria:

  • previous shoulder surgery;
  • shoulder pain reproduced by neck movement;
  • clinical signs of full-thickness RC tears; or
  • shoulder capsulitis.

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: Double

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: scapula retraction exercise group
  • Manual Therapy
  • Stretching Exercises
  • Exercise training focus on scapulothoracic muscles will be applied two times per week total 12 week After 12 week follow-up, patients will proceed to reduced exercise program until the 6-month follow-up.
Other: Scapula Retraction Exercise Group

physiotherapy program consists of manual therapy, supervised stretching and scapulothoracic muscles strengthening exercises and home exercise programme including stretching and strengthening exercises will be applied two times a week total 24 sessions.

After 24 sessions completed, patients will proceed to reduced exercise program until the 6-month follow-up.

Other Names:
  • scapula stabilization exercises
Experimental: Scapula Retraction +Glenohumeral Rotational Exercise Group
  • Manual Therapy
  • Stretching Exercises
  • Exercise training focus on scapulothoracic muscles
  • Exercise training focus on rotator cuff muscles will be applied two times per week total 12 week After 12 week follow-up, patients will proceed to reduced exercise program until the 6-month follow-up.
Other: Scapula Retraction +Glenohumeral Rotational Exercise Group

physiotherapy program consists of manual therapy, supervised stretching and scapulothoracic and also rotator cuff muscles strengthening exercises and home exercise programme including stretching and strengthening exercises will be applied two times a week total 24 sessions.

After 24 sessions completed, patients will proceed to reduced exercise program until the 6-month follow-up

Other Names:
  • Scapula stabilization +Glenohumeral Rotational Exercise Group
No Intervention: Control Group
Age-sex and hand-dominancy matched healthy controls will be included as a control group (CG) for acromiohumeral distance (AHD) normative data

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
Functional Level
Time Frame: ffrom baseline to twelve week after treatment sessions
Functional level will be assessed by using Shoulder Pain and Disability Index (SPADİ). All assessment will be recorded at baseline, at the end of the 12-week treatment sessions and 6-month follow-up.
ffrom baseline to twelve week after treatment sessions

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pain assessment
Time Frame: from baseline to 6-month follow up
pain intensity will de assessed by using Visual Analog Scale at rest, activity and at night. All assessment will be recorded at baseline, at the end of the 12-week treatment sessions and 6-month follow-up.
from baseline to 6-month follow up
Acromiohumeral Distance Measurement
Time Frame: from baseline to 6-month follow up
Acromiohumeral Distance will be measured by 0°, 30°, 45°, 60° and 90° of shoulder abduction positions. All assessment will be recorded at baseline, at the end of the 12-week treatment sessions and 6-month follow-up.
from baseline to 6-month follow up
Patient Satisfaction
Time Frame: at 12 week and 6-month follow ups
Patient Satisfaction will be assessed by simple questions consisting of self- recovery rate and patients expectation
at 12 week and 6-month follow ups

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.
Hacettepe 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.
August 1, 2018

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 15, 2020

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.
February 15, 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).
March 27, 2018

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.
April 9, 2018

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.
April 11, 2018

Study Record Updates

Last Update Posted (Actual)

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.
February 3, 2022

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.
January 20, 2022

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.
January 1, 2022

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.
  • KA-180018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We will share IPD when we recruiting the patients

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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