- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03246698
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
70
Phase
- 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
-
-
Balçova
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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
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 |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Isolytic stretching group
The participants in this group will receive isolytic stretching in modified cross body position.
Additionally they will receive 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.
Other Names:
|
|
EXPERIMENTAL: Static stretching group
The participants in this group will receive static stretching in modified cross body position. Additionally they will receive 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.
Other Names:
|
|
ACTIVE_COMPARATOR: Control group
The participants in this group will receive only standard physiotherapy.
|
They will receive only standard physiotherapy program, four times a week for four weeks, 15 sessions in total.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
August 28, 2017
Primary Completion (ACTUAL)
June 20, 2019
Study Completion (ACTUAL)
July 20, 2019
Study Registration Dates
First Submitted
August 8, 2017
First Submitted That Met QC Criteria
August 8, 2017
First Posted (ACTUAL)
August 11, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 18, 2022
Last Update Submitted That Met QC Criteria
July 14, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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