A Comparison of the Long Term Effects of the Traditional and Modified Posterior Shoulder Stretching Exercise in Subacromial Impingement Syndrome

November 3, 2024 updated by: Halime Ezgi TÜRKSAN, Dokuz Eylul University

A Comparison of the Long Term Effects of the Traditional and Modified Posterior Shoulder Stretching Exercise on Shoulder Mobility, Pain, Ultrasonographic Parameters, Proprioception, Strength, Functionality, and Disability Level in Subacromial Impingement Syndrome

The purpose of this study is to investigate and compare the long term effects of traditional and modified static cross-body posterior shoulder stretching training in individuals with subacromial impingement syndrome (SIS) having glenohumeral internal rotation deficit (GIRD). Modified cross body posterior shoulder stretching group will receive static stretching in the modified cross-body stretching position and standard physiotherapy program. The traditional cross body posterior shoulder stretching group will receive static stretching and standard physiotherapy program. The Control group will receive only sham stretching and standard physiotherapy program.

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

SIS is the most common cause of pain and shoulder dysfunction. The etiology of SIS depends on many factors including tightness of the posterior shoulder structures. Posterior shoulder tightness (PST) narrows the subacromial space and forces anterior-superior migration of the humeral head over the glenoid fossa and, it could cause limitation of the internal rotation (IR) and horizontal adduction range of motion (ROM). GIRD is known as loss of IR ROM in the glenohumeral joint. In the SIS, limitation IR ROM has been reported. Supraspinatus tendon thickness can change, subacromial space may become narrower and joint position sense (JPS) could be decreased in SIS patients. The effectiveness of traditional static cross body posterior shoulder stretching on various parameters such as shoulder rotational ROM or pain was studied and proved in the literature. Traditional static cross body posterior shoulder stretching could reduce subacromial symptoms and improve shoulder ROM with some disadvantages such as inadequate control of the scapula and glenohumeral rotation. To prevent accessory abduction of the scapula, restrict the external rotation ROM of the humerus and provide isolated posterior capsule stretching, Wilk et al. (2013) recommend the use of modified cross-body stretching for IR ROM increase. In the modified cross-body position, the patient is positioned in a more advantageous way. In the literature, although modified cross-body posterior stretching seems effective on SIS symptoms there is no research about the comparison of the long-term effects of the traditional and modified static cross-body posterior shoulder stretching exercises in individuals with SIS having GIRD. Therefore, whether modified stretching is superior to traditional stretching is not known. Our study aims to investigate and compare the long term effects of the traditional static cross-body posterior shoulder stretching exercise and modified static cross-body posterior shoulder stretching exercise in individuals with SIS having GIRD on shoulder IR ROM, GIRD, PST, pain, external rotation ROM, JPS, subacromial space, supraspinatus tendon thickness, posterior capsule thickness, the occupational ratio of the supraspinatus tendon in the subacromial space, muscle strength and shoulder function and disability level. Stretching groups will receive either traditional or modified static cross-body posterior shoulder stretching exercise and standard physiotherapy program. The Control group will receive only sham stretching and standard physiotherapy program. Standard physiotherapy program consists of electrotherapy, posture, proprioceptive, and strengthening exercises. The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.

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.
60

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Balçova
      • İzmir, Balçova, Turkey
        • Dokuz Eylül University Physical Therapy and Rehabilitation Department

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of subacromial impingement syndrome
  • Glenohumeral internal rotation range of motion of the affected shoulder should be less than other shoulder and bilateral shoulder internal rotation range of motion difference should be ≥15 º
  • Pain with resisted arm elevation or external rotation as well as a minimum of 3 of 5 positive subacromial impingement syndrome tests, painful arc, pain or weakness with resisted external rotation, Neer, Hawkins and Jobe tests .
  • Ability to complete the entire study procedure

Exclusion Criteria:

  • A 50% limitation of passive shoulder range of motion in >2 planes of motion
  • Pain >7/10
  • A history of fracture to the shoulder girdle
  • Systemic musculoskeletal disease
  • History of shoulder surgery,
  • Glenohumeral instability (positive apprehension, relocation or positive sulcus test) or positive findings for a full thickness rotator cuff tear (positive lag sign, positive drop arm test, or marked weakness with shoulder external rotation)

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: Modified static cross-body posterior shoulder stretching group
The participants will perform active-assistive static stretching in the modified cross-body stretching position. Additionally, they will receive standard physiotherapy program.
Other: Modified static cross-body posterior shoulder stretching
For the modified cross-body position patient will be positioned in the side-lying position to limit the scapular abduction, and the patient aligned his/her forearms to limit the ER of the humerus while moving into horizontal adduction (HAdd). First, we will ask the patient to pull his/her arm into HAdd to the physiological barrier of the ROM, and then the patient will perform active-assistive static stretching with the help of the other hand for 30 seconds. The stretching will perform five repetitions with 10-sec rest between stretches. Each stretching will begin from a new physiological barrier of the HAdd ROM. Patients will also receive the standard physiotherapy program consists of physical agents, posture, proprioceptive, and strengthening exercises. The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.
Experimental: Traditional static cross-body posterior shoulder stretching group
The participants will perform active-assistive static stretching in the traditional standing cross-body stretching position. Additionally, they will receive standard physiotherapy program.
Other: Traditional static cross-body posterior shoulder stretching
For the traditional static cross-body posterior shoulder stretching, in the standing position, the patient will perform cross-body stretch alone by active-assistive pulling the humerus across the body into HAdd with the opposite arm, without concern for scapular stabilization for 30 sec. The stretching will perform five repetitions with 10-sec rest between stretches. Each stretching will begin from a new physiological barrier of the HAdd ROM. Patients will also receive the standard physiotherapy program consists of physical agents, posture, proprioceptive, and strengthening exercises. The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.
Active Comparator: Control Group
The participants in this group will receive sham stretching and standard physiotherapy.
Other: Control Group
In sham stretching, the patient will be positioned in the traditional static cross body posterior shoulder stretching position, and then the patient will perform active-assistive HAdd ROM without enough stretching of the relevant tissue. Active assistive ROM will be stopped before reaching the individual PST measurement result (in this way, sham stretching will be performed without proper stretching of the relevant tissue). The HAdd ROM exercise will be performed 5 times. Patients will also receive the standard physiotherapy program consists of physical agents, posture, proprioceptive, and strengthening exercises. The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.

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
Shoulder internal rotation range of motion
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of shoulder internal rotation range of motion (with bubble inclinometer)
Baseline, 8 weeks, 12 weeks, 24 weeks
Glenohumeral internal rotation deficit
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of glenohumeral internal rotation deficit (with bubble inclinometer)
Baseline, 8 weeks, 12 weeks, 24 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
Posterior shoulder tightness
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of posterior shoulder tightness (with bubble inclinometer)
Baseline, 8 weeks, 12 weeks, 24 weeks
Pain intensity
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of visual analog scale score in activity and rest
Baseline, 8 weeks, 12 weeks, 24 weeks
Joint position sense
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of shoulder joint repositioning angle errors for external rotation 0-45 degree, for internal rotation 0-45 degree, for scapular plane elevation 0-100 degree (with bubble inclinometer)
Baseline, 8 weeks, 12 weeks, 24 weeks
Isometric strength
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of shoulder abduction, internal rotation, and external rotation isometric strength (in kg, with hand held dynamometer)
Baseline, 8 weeks, 12 weeks, 24 weeks
Subacromial space
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of subacromial space at neutral (0 degree), 30, 45, and 60-degree scapular plane elevation(with Ultrasound)
Baseline, 8 weeks, 12 weeks, 24 weeks
Supraspinatus tendon thickness
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of supraspinatus tendon thickness (with Ultrasound)
Baseline, 8 weeks, 12 weeks, 24 weeks
Shoulder external rotation range of motion
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of shoulder external rotation range of motion (with bubble inclinometer)
Baseline, 8 weeks, 12 weeks, 24 weeks
Posterior capsule thickness
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of posterior capsule thickness (with Ultrasound)
Baseline, 8 weeks, 12 weeks, 24 weeks
Occupational ratio of the supraspinatus tendon in the acromial-humeral space
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of occupational rate of the supraspinatus tendon in the acromial-humeral space
Baseline, 8 weeks, 12 weeks, 24 weeks
Shoulder Function
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of Modified Constant-Murley Score
Baseline, 8 weeks, 12 weeks, 24 weeks
Upper extremity function
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of disabilities of the arm, shoulder, and hand (DASH) score
Baseline, 8 weeks, 12 weeks, 24 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.
Dokuz Eylul University

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.
  • Study Director: Sevgi Sevi YESILYAPRAK, PhD, PT, Dokuz Eylül University Physical Therapy and Rehabilitation Department
  • Study Director: Onur BAŞÇI, MD, Dokuz Eylül University
  • Study Director: Mehmet ERDURAN, MD, Dokuz Eylül University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
September 21, 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.
September 21, 2024

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.
September 21, 2024

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 28, 2020

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.
December 3, 2020

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 9, 2020

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.
November 5, 2024

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.
November 3, 2024

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, 2024

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.
  • 3032-GOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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