The Effect of Isolytic and Static Stretching Training in Individuals With Subacromial Impingement Syndrome

July 14, 2022 updated by: Halime Ezgi TÜRKSAN, Dokuz Eylul University

The Effect of Isolytic and Static Stretching Training in Individuals Having Subacromial Impingement Syndrome With Glenohumeral Internal Rotation Deficit

The purpose of this study is to investigate and compare the effect of isolytic and static stretching training in individuals having subacromial impingement syndrome with glenohumeral internal rotation deficit. Isolytic group will receive isolytic stretching in modified cross body stretching position and standard physiotherapy program. Static group will receive static stretching in modified cross body stretching position and standard physiotherapy program. Control group will receive only 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

The effectiveness of static stretching on various parameters such as range of motion or pain is studied and proved in literature. Static stretching in cross body position was also found helpful for improving shoulder range of motion with some disadvantages. In modified cross body position, the patient is positioned in a more advantageous way for him/her. Usually this stretching is done as active-assistive static stretching with the physiotherapist. Proof is still needed for the effectiveness of active-assistive static stretching in modified cross body position. Furthermore, there is no research about the effect of isolytic stretching which is relatively new technique compare to static stretches in subacromial impingement syndrome. In isolytic stretching, when the patient contracts the agonist muscle group with 20% muscle force active-assistive streching in agonist muscle group by the physiotherapist at the same time is done for 2-4 seconds. A fast isolytic stretching is applied in order to break the fibrous tissue. Our purpose is to investigate and compare the effect of isolytic and static stretching training in individuals having subacromial impingement syndrome with glenohumeral internal rotation deficit . Stretching groups will receive either isolytic or static stretching in modified cross body stretching position and standard physiotherapy program. There is a control group. Control group will receive only standard physiotherapy program. Standard physiotherapy program includes TENS, hotpack, posture and strengthening training program. Treatment program will last four times a week (4-4-4-3) for four weeks, 15 sessions in total.

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.
70

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
    • Balçova
      • İzmir, Balçova, Turkey
        • Dokuz Eylul 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 and cervical 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)
  • Neck and shoulder pain with active/passive cervical spine movement
  • A diagnosis of chest deformity or scoliosis
  • Regularly performing posterior shoulder stretching exercises

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
  • 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: Isolytic stretching group
The participants in this group will receive isolytic stretching in modified cross body position. Additionally they will receive standard physiotherapy.
Other: Isolytic Stretching group
In modified cross body position, isolytic stretching exercises will perform five times each for 15 seconds. After each stretching patient will rest for 5 seconds. When the patient contracts the agonist muscle group with 20% muscle force, the agonist muscle group is stretched at the same time for 2-4 seconds. Isolytic stretching exercises will perform four times a week for four weeks. It's obligatory to receive at least 15 sessions in total. They will also receive standard physiotherapy program four times a week for four week, 15 sessions in total.
Other Names:
  • Standard physiotherapy
EXPERIMENTAL: Static stretching group

The participants in this group will receive static stretching in modified cross body position.

Additionally they will receive standard physiotherapy.
Other: Static Stretching group
In modified cross body position, active-assistive static stretching exercises will be performed 5 times each for 15 seconds. This stretching exercise is performed 5 times with 5 seconds intervals. Static stretching exercises will perform four times a week for four weeks. It's obligatory to receive at least 15 sessions in total. They will also receive standard physiotherapy program four times a week for four week, 15 sessions in total.
Other Names:
  • Standard physiotherapy
ACTIVE_COMPARATOR: Control group
The participants in this group will receive only standard physiotherapy.
Other: Control group
They will receive only standard physiotherapy program, four times a week for four weeks, 15 sessions in total.
Other Names:
  • Standard physiotherapy

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 and 4 weeks
Change of shoulder internal rotation range of motion (with bubble inclinometer)
Baseline and 4 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
Glenohumeral internal rotation deficit
Time Frame: Baseline and 4 weeks
Change of difference in shoulder internal rotation range of motion between the affected and non-affected shoulder (with bubble inclinometer)
Baseline and 4 weeks
Posterior shoulder tightness
Time Frame: Baseline and 4 weeks
Change of posterior shoulder tightness (with bubble inclinometer)
Baseline and 4 weeks
Shoulder external rotation range of motion
Time Frame: Baseline and 4 weeks
Change of shoulder external rotation range of motion (with bubble inclinometer)
Baseline and 4 weeks
Shoulder total rotational range of motion
Time Frame: Baseline and 4 weeks
Change of shoulder total rotational range of motion (Sum of the internal and external rotation motion)
Baseline and 4 weeks
Resting and activitiy pain in shoulder
Time Frame: Baseline and 4 weeks
Change of visual analog scale score in activity and rest pain
Baseline and 4 weeks
Subacromial space
Time Frame: Baseline and 4 weeks
Change of subacromial space at arm resting at the side (0°), and at 60° of scapular plane elevation (with Ultrasound)
Baseline and 4 weeks
Supraspinatus tendon thickness
Time Frame: Baseline and 4 weeks
Change of supraspinatus tendon thickness (with Ultrasound)
Baseline and 4 weeks
Concentric strength
Time Frame: Baseline and 4 weeks
Change of rotattor cuff muscles concentric strength (in kg, with hand held dynamometer)
Baseline and 4 weeks
Eccentric strength
Time Frame: Baseline and 4 weeks
Change of shoulder abduction eccentric strength (in kg, with hand held dynamometer)
Baseline and 4 weeks
Shoulder Function
Time Frame: Baseline and 4 weeks
Change of Modified Constant-Murley Score
Baseline and 4 weeks
Upper extremity function
Time Frame: Baseline and 4 weeks
Change of disabilities of the arm, shoulder, and hand (Quick-DASH) score
Baseline and 4 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

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 28, 2017

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.
June 20, 2019

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.
July 20, 2019

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).
August 8, 2017

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.
August 8, 2017

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.
August 11, 2017

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.
July 18, 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.
July 14, 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.
July 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.
  • 3413-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

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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