Subacromial Impingement SyndromeNCT03246867

The Acute Effects of Different Stretching Methods in Individuals With Subacromial Impingement Syndrome

A study testing Isolytic stretching group and Static stretching group in people with Subacromial Impingement Syndrome and Glenohumeral Internal Rotation Deficit, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Subacromial Impingement Syndrome, Glenohumeral Internal Rotation Deficit
What is being tested?: Isolytic stretching group and Static stretching group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 28 Aug 2017to 2 Jan 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

An inability to elevate the involved arm greater than 140 degree in the scapular plane
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)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Dokuz Eylül University
Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: The Acute Effects of Different Stretching Methods on Posterior Shoulder Tightness, Pain, Joint Range of Motion, Subacromial Space and Strength in Individuals Having Subacromial Impingement Syndrome With Glenohumeral Internal Rotation Deficit

The purpose of this study is to investigate and compare the acute effects 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 position. Static group will receive static stretching in modified cross body position. Stretching groups will be evaluated before and just after stretching exercise. Control group will receive no stretching. Control group will be evaluated for the first time and then will be waited until the duration of the stretching exercise program. Afterwards, second evaluation will be performed

Read the detailed description

There is no information in literature about the acute effects of isolytic stretching exercise in individuals having subacromial impingement syndrome with glenohumeral internal rotation deficit. The purpose of this study is to investigate and compare the acute effects of isolytic and static stretching training in individuals having subacromial impingement syndrome with glenohumeral internal rotation deficit.

In modified cross body position, static stretching group will perform active-assistive static stretching by the physiotherapist whereas isolytic stretching group will perform active-assistive isolytic stretching. Stretching exercises will be applied five times each for 15 seconds. After each stretching there will be a resting period for 5 seconds. Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Isolytic and static stretching groups will be evaluated before and just after stretching exercise. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.

Conditions: Subacromial Impingement Syndrome, Glenohumeral Internal Rotation Deficit
Being tested: Isolytic stretching group, Static stretching group, Control group
Keywords: isolytic stretching, static stretching, Glenohumeral Internal Rotation Deficit
Medical subject headings: Shoulder Impingement Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Isolytic stretching groupOther
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. Afterwards active-assistive stretching is done. Evaluations will be done before and just after stretching exercise.
Static stretching groupOther
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. Evaluations will be done before and just after stretching exercise.
Control groupOther
Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.

Study groups in NCT03246867
Study group	Role	What they receive
Isolytic stretching group	Experimental	The participants in this group will receive isolytic stretching in modified cross body position. Receives: Other: Isolytic stretching group
Static stretching group	Experimental	The participants in this group will receive static stretching in modified cross body position. Receives: Other: Static stretching group
Control group	Active comparator	The participants in this group will receive no stretching. They will only be evaluated. Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

Shoulder internal rotation range of motion
Change of shoulder internal rotation range of motion (with bubble inclinometer)
Measured: Baseline and just after stretching exercise

Secondary outcomes (6)

Posterior shoulder tightness
Change of posterior shoulder tightness (with bubble inclinometer)
Measured: Baseline and just after stretching exercise
Concentric strength
Change of trapezius muscles, rotattor cuff muscles concentric strength (in kg, with hand held dynamometer)
Measured: Baseline and just after stretching exercise
Eccentric strength
Change of shoulder abduction and external rotation eccentric strength (in kg, with hand held dynamometer)
Measured: Baseline and just after stretching exercise
Subacromial space
Change of subacromial space ( with Ultrasound)
Measured: Baseline and just after stretching exercise
Pain
Change of visual analog scale score in activity and rest
Measured: Baseline and just after stretching exercise
Shoulder external rotation range of motion
Change of shoulder external rotation range of motion (with bubble inclinometer)
Measured: Baseline and just after stretching exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 20172 Jan 2020

First posted11 Aug 2017
Study start28 Aug 2017
Primary completion15 Dec 2019
Study completion2 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: There are 3 groups. First group will receive isolytic stretching in modified cross body position. Second group will receive static stretching in modified cross body position. The stretching exercise will be applied five times each for 15 seconds. After each stretching there will be a resting period for 5 seconds. Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Isolytic and static stretching groups will be evaluated before and just after stretching exercise. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.
Masking: Single blind
Who is masked: Participant
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03246867
Sponsor's protocol ID: 3418-GOA
Status last verified: Feb 2020
First submitted: 8 Aug 2017
Last updated: 21 Feb 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Subacromial Impingement Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Acute Effects of Different Stretching Methods on Posterior Shoulder Tightness, Pain, Joint Range of Motion, Subacromial Space and Strength in Individuals Having Subacromial Impingement Syndrome With Glenohumeral Internal Rotation Deficit
ClinicalTrials.gov ID: NCT03246867
Acronym / sponsor ID: 3418-GOA
Conditions: Subacromial Impingement Syndrome, Glenohumeral Internal Rotation Deficit
Keywords: isolytic stretching, static stretching, Glenohumeral Internal Rotation Deficit
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Dokuz Eylul UniversityUniversity, hospital or other
Study start: 28 Aug 2017 (actual)
Primary completion: 15 Dec 2019 (actual)
Study completion: 2 Jan 2020 (actual)
First posted: 11 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: There are 3 groups. First group will receive isolytic stretching in modified cross body position. Second group will receive static stretching in modified cross body position. The stretching exercise will be applied five times each for 15 seconds. After each stretching there will be a resting period for 5 seconds. Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Isolytic and static stretching groups will be evaluated before and just after stretching exercise. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.

Arm	Type	Receives
Isolytic stretching group	Experimental	Other: Isolytic stretching groupThe participants in this group will receive isolytic stretching in modified cross body position.
Static stretching group	Experimental	Other: Static stretching groupThe participants in this group will receive static stretching in modified cross body position.
Control group	Active comparator	Other: Control groupThe participants in this group will receive no stretching. They will only be evaluated.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

An inability to elevate the involved arm greater than 140 degree in the scapular plane
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Isolytic stretching groupIn 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. Afterwards active-assistive stretching is done. Evaluations will be done before and just after stretching exercise.	Other	Isolytic stretching group
Static stretching groupIn 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. Evaluations will be done before and just after stretching exercise.	Other	Static stretching group
Control groupControl group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.	Other	Control group

Primary outcome

Shoulder internal rotation range of motion
Time frame: Baseline and just after stretching exercise
Change of shoulder internal rotation range of motion (with bubble inclinometer)

6 secondary outcomes

Posterior shoulder tightness
Time frame: Baseline and just after stretching exercise
Concentric strength
Time frame: Baseline and just after stretching exercise
Eccentric strength
Time frame: Baseline and just after stretching exercise
Subacromial space
Time frame: Baseline and just after stretching exercise
Pain
Time frame: Baseline and just after stretching exercise
Shoulder external rotation range of motion
Time frame: Baseline and just after stretching exercise

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.

Related trials for Subacromial Impingement Syndrome

Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
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Recruiting
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Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
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Active, not recruitingObservational study
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sevgi Sevi YESILYAPRAK, PhD study director

Dokuz Eylul University

Damla GULPINAR, MS study director

Izmir Katip Celebi University

Mehmet ERDURAN, MD study director

Dokuz Eylul University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder internal rotation range of motion (time frame: Baseline and just after stretching exercise). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03246867.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.