The Effect of Isolytic and Static Stretching Training in Individuals With Subacromial Impingement Syndrome
Primary Purpose
Subacromial Impingement Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Isolytic Stretching group
Static Stretching group
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring Shoulder pain, Physical therapy, Rehabilitation, Ultrasonography
Eligibility Criteria
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
Sites / Locations
- Dokuz Eylül University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Isolytic stretching group
Static stretching group
Control group
Arm Description
The participants in this group will receive isolytic stretching in modified cross body position. Additionally they will receive standard physiotherapy.
The participants in this group will receive static stretching in modified cross body position. Additionally they will receive standard physiotherapy.
The participants in this group will receive only standard physiotherapy.
Outcomes
Primary Outcome Measures
Shoulder internal rotation range of motion
Change of shoulder internal rotation range of motion (with bubble inclinometer)
Secondary Outcome Measures
Glenohumeral internal rotation deficit
Change of difference in shoulder internal rotation range of motion between the affected and non-affected shoulder (with bubble inclinometer)
Posterior shoulder tightness
Change of posterior shoulder tightness (with bubble inclinometer)
Shoulder external rotation range of motion
Change of shoulder external rotation range of motion (with bubble inclinometer)
Shoulder total rotational range of motion
Change of shoulder total rotational range of motion (Sum of the internal and external rotation motion)
Resting and activitiy pain in shoulder
Change of visual analog scale score in activity and rest pain
Subacromial space
Change of subacromial space at arm resting at the side (0°), and at 60° of scapular plane elevation (with Ultrasound)
Supraspinatus tendon thickness
Change of supraspinatus tendon thickness (with Ultrasound)
Concentric strength
Change of rotattor cuff muscles concentric strength (in kg, with hand held dynamometer)
Eccentric strength
Change of shoulder abduction eccentric strength (in kg, with hand held dynamometer)
Shoulder Function
Change of Modified Constant-Murley Score
Upper extremity function
Change of disabilities of the arm, shoulder, and hand (Quick-DASH) score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03246698
Brief Title
The Effect of Isolytic and Static Stretching Training in Individuals With Subacromial Impingement Syndrome
Official Title
The Effect of Isolytic and Static Stretching Training in Individuals Having Subacromial Impingement Syndrome With Glenohumeral Internal Rotation Deficit
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
July 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
Shoulder pain, Physical therapy, Rehabilitation, Ultrasonography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
All of participants must have subacromial impingement syndrome with glenohumeral internal rotation deficit.
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isolytic stretching group
Arm Type
Experimental
Arm Description
The participants in this group will receive isolytic stretching in modified cross body position. Additionally they will receive standard physiotherapy.
Arm Title
Static stretching group
Arm Type
Experimental
Arm Description
The participants in this group will receive static stretching in modified cross body position.
Additionally they will receive standard physiotherapy.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The participants in this group will receive only standard physiotherapy.
Intervention Type
Other
Intervention Name(s)
Isolytic Stretching group
Other Intervention Name(s)
Standard physiotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Static Stretching group
Other Intervention Name(s)
Standard physiotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
Standard physiotherapy
Intervention Description
They will receive only standard physiotherapy program, four times a week for four weeks, 15 sessions in total.
Primary Outcome Measure Information:
Title
Shoulder internal rotation range of motion
Description
Change of shoulder internal rotation range of motion (with bubble inclinometer)
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Glenohumeral internal rotation deficit
Description
Change of difference in shoulder internal rotation range of motion between the affected and non-affected shoulder (with bubble inclinometer)
Time Frame
Baseline and 4 weeks
Title
Posterior shoulder tightness
Description
Change of posterior shoulder tightness (with bubble inclinometer)
Time Frame
Baseline and 4 weeks
Title
Shoulder external rotation range of motion
Description
Change of shoulder external rotation range of motion (with bubble inclinometer)
Time Frame
Baseline and 4 weeks
Title
Shoulder total rotational range of motion
Description
Change of shoulder total rotational range of motion (Sum of the internal and external rotation motion)
Time Frame
Baseline and 4 weeks
Title
Resting and activitiy pain in shoulder
Description
Change of visual analog scale score in activity and rest pain
Time Frame
Baseline and 4 weeks
Title
Subacromial space
Description
Change of subacromial space at arm resting at the side (0°), and at 60° of scapular plane elevation (with Ultrasound)
Time Frame
Baseline and 4 weeks
Title
Supraspinatus tendon thickness
Description
Change of supraspinatus tendon thickness (with Ultrasound)
Time Frame
Baseline and 4 weeks
Title
Concentric strength
Description
Change of rotattor cuff muscles concentric strength (in kg, with hand held dynamometer)
Time Frame
Baseline and 4 weeks
Title
Eccentric strength
Description
Change of shoulder abduction eccentric strength (in kg, with hand held dynamometer)
Time Frame
Baseline and 4 weeks
Title
Shoulder Function
Description
Change of Modified Constant-Murley Score
Time Frame
Baseline and 4 weeks
Title
Upper extremity function
Description
Change of disabilities of the arm, shoulder, and hand (Quick-DASH) score
Time Frame
Baseline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevgi Sevi YESILYAPRAK, PhD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mehmet ERDURAN, MD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cem OZCAN, MD
Organizational Affiliation
Izmır Katip Celebi University Atatürk Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Dokuz Eylül University
City
İzmir
State/Province
Balçova
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Isolytic and Static Stretching Training in Individuals With Subacromial Impingement Syndrome
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