Subacromial Impingement SyndromeNCT03246698
The Effect of Isolytic and Static Stretching Training in Individuals With Subacromial Impingement Syndrome
A study testing Isolytic Stretching group and Static Stretching group in people with Subacromial Impingement Syndrome, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement Syndrome
- 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
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2017to 20 Jul 2019
- 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
- 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)
Show all 9Show fewer
- Neck and shoulder pain with active/passive cervical spine movement
- A diagnosis of chest deformity or scoliosis
- Regularly performing posterior shoulder stretching exercises
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Isolytic Stretching group, Static Stretching group, Control group
- Keywords
- Shoulder pain, Physical therapy, Rehabilitation, Ultrasonography
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolytic Stretching groupOther
Also called Standard physiotherapy
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.
Static Stretching groupOther
Also called Standard physiotherapy
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.
Control groupOther
Also called Standard physiotherapy
They will receive only standard physiotherapy program, four times a week for four weeks, 15 sessions in total.
| Study group | Role | What they receive |
|---|---|---|
| Isolytic stretching group | Experimental | The participants in this group will receive isolytic stretching in modified cross body position. Additionally they will receive standard physiotherapy. Receives: Other: Isolytic Stretching group |
| Static stretching group | Experimental | The participants in this group will receive static stretching in modified cross body position.
Additionally they will receive standard physiotherapy. Receives: Other: Static Stretching group |
| Control group | Active comparator | The participants in this group will receive only standard physiotherapy. 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 4 weeks
Secondary outcomes (11)
Glenohumeral internal rotation deficit
Change of difference in shoulder internal rotation range of motion between the affected and non-affected shoulder (with bubble inclinometer)
Measured: Baseline and 4 weeks
Posterior shoulder tightness
Change of posterior shoulder tightness (with bubble inclinometer)
Measured: Baseline and 4 weeks
Shoulder external rotation range of motion
Change of shoulder external rotation range of motion (with bubble inclinometer)
Measured: Baseline and 4 weeks
Shoulder total rotational range of motion
Change of shoulder total rotational range of motion (Sum of the internal and external rotation motion)
Measured: Baseline and 4 weeks
Resting and activitiy pain in shoulder
Change of visual analog scale score in activity and rest pain
Measured: Baseline and 4 weeks
Subacromial space
Change of subacromial space at arm resting at the side (0°), and at 60° of scapular plane elevation (with Ultrasound)
Measured: Baseline and 4 weeks
Supraspinatus tendon thickness
Change of supraspinatus tendon thickness (with Ultrasound)
Measured: Baseline and 4 weeks
Concentric strength
Change of rotattor cuff muscles concentric strength (in kg, with hand held dynamometer)
Measured: Baseline and 4 weeks
Eccentric strength
Change of shoulder abduction eccentric strength (in kg, with hand held dynamometer)
Measured: Baseline and 4 weeks
Shoulder Function
Change of Modified Constant-Murley Score
Measured: Baseline and 4 weeks
Upper extremity function
Change of disabilities of the arm, shoulder, and hand (Quick-DASH) score
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start28 Aug 2017
- Primary completion20 Jun 2019
- Study completion20 Jul 2019
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 stretching position and standard physiotherapy program. Second group will receive static stretching in modified cross body stretching position and standard physiotherapy program. Control group will receive only standard physiotherapy program. In standard physiotherapy program, there are TENS, hotpack, posture and strengthening training program. Treatment program will last four weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime Ezgi TÜRKSAN, Dokuz Eylul University
- Investigators
- Sevgi Sevi YESILYAPRAK, PhD, Study director, Dokuz Eylul UniversityMehmet ERDURAN, MD, Study director, Dokuz Eylul UniversityCem OZCAN, MD, Study director, Izmır Katip Celebi University Atatürk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246698
- Sponsor's protocol ID
- 3413-GOA
- Status last verified
- Jul 2022
- First submitted
- 8 Aug 2017
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Isolytic and Static Stretching Training in Individuals Having Subacromial Impingement Syndrome With Glenohumeral Internal Rotation Deficit
- ClinicalTrials.gov ID
- NCT03246698
- Acronym / sponsor ID
- 3413-GOA
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Shoulder pain, Physical therapy, Rehabilitation, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jul 2019 (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.
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.
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 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 stretching position and standard physiotherapy program. Second group will receive static stretching in modified cross body stretching position and standard physiotherapy program. Control group will receive only standard physiotherapy program. In standard physiotherapy program, there are TENS, hotpack, posture and strengthening training program. Treatment program will last four weeks.
| Arm | Type | Receives |
|---|---|---|
| Isolytic stretching group | Experimental | Other: Isolytic Stretching groupThe participants in this group will receive isolytic stretching in modified cross body position. Additionally they will receive standard physiotherapy. |
| Static stretching group | Experimental | Other: Static Stretching groupThe participants in this group will receive static stretching in modified cross body position. Additionally they will receive standard physiotherapy. |
| Control group | Active comparator | Other: Control groupThe participants in this group will receive only standard physiotherapy. |
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 (9 listed)
- 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
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 groupAlso: Standard physiotherapyIn 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 | Isolytic stretching group |
| Static Stretching groupAlso: Standard physiotherapyIn 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 | Static stretching group |
| Control groupAlso: Standard physiotherapyThey will receive only standard physiotherapy program, four times a week for four weeks, 15 sessions in total. | Other | Control group |
Primary outcome
Shoulder internal rotation range of motion
Time frame: Baseline and 4 weeks
Change of shoulder internal rotation range of motion (with bubble inclinometer)
11 secondary outcomes
Glenohumeral internal rotation deficit
Time frame: Baseline and 4 weeks
Posterior shoulder tightness
Time frame: Baseline and 4 weeks
Shoulder external rotation range of motion
Time frame: Baseline and 4 weeks
Shoulder total rotational range of motion
Time frame: Baseline and 4 weeks
Resting and activitiy pain in shoulder
Time frame: Baseline and 4 weeks
Subacromial space
Time frame: Baseline and 4 weeks
Supraspinatus tendon thickness
Time frame: Baseline and 4 weeks
Concentric strength
Time frame: Baseline and 4 weeks
Eccentric strength
Time frame: Baseline and 4 weeks
Shoulder Function
Time frame: Baseline and 4 weeks
Upper extremity function
Time frame: Baseline and 4 weeks
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 18 Jul 2022.
- Individual participant dataSharing planned: No
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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
Mehmet ERDURAN, MD study director
Dokuz Eylul University
Cem OZCAN, MD study director
Izmır Katip Celebi University Atatürk Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolytic Stretching group and Static Stretching group in people with Subacromial Impingement Syndrome, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 9 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 18 Jul 2022. 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 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2022.