- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04660682
A Comparison of the Long Term Effects of the Traditional and Modified Posterior Shoulder Stretching Exercise in Subacromial Impingement Syndrome
February 18, 2024 updated by: Halime Ezgi TÜRKSAN, Dokuz Eylul University
A Comparison of the Long Term Effects of the Traditional and Modified Posterior Shoulder Stretching Exercise on Shoulder Mobility, Pain, Ultrasonographic Parameters, Proprioception, Strength, Functionality, and Disability Level in Subacromial Impingement Syndrome
The purpose of this study is to investigate and compare the long term effects of traditional and modified static cross-body posterior shoulder stretching training in individuals with subacromial impingement syndrome (SIS) having glenohumeral internal rotation deficit (GIRD).
Modified cross body posterior shoulder stretching group will receive static stretching in the modified cross-body stretching position and standard physiotherapy program.
The traditional cross body posterior shoulder stretching group will receive static stretching and standard physiotherapy program.
The Control group will receive only sham stretching and standard physiotherapy program.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
SIS is the most common cause of pain and shoulder dysfunction.
The etiology of SIS depends on many factors including tightness of the posterior shoulder structures.
Posterior shoulder tightness (PST) narrows the subacromial space and forces anterior-superior migration of the humeral head over the glenoid fossa and, it could cause limitation of the internal rotation (IR) and horizontal adduction range of motion (ROM).
GIRD is known as loss of IR ROM in the glenohumeral joint.
In the SIS, limitation IR ROM has been reported.
Supraspinatus tendon thickness can change, subacromial space may become narrower and joint position sense (JPS) could be decreased in SIS patients.
The effectiveness of traditional static cross body posterior shoulder stretching on various parameters such as shoulder rotational ROM or pain was studied and proved in the literature.
Traditional static cross body posterior shoulder stretching could reduce subacromial symptoms and improve shoulder ROM with some disadvantages such as inadequate control of the scapula and glenohumeral rotation.
To prevent accessory abduction of the scapula, restrict the external rotation ROM of the humerus and provide isolated posterior capsule stretching, Wilk et al. (2013) recommend the use of modified cross-body stretching for IR ROM increase.
In the modified cross-body position, the patient is positioned in a more advantageous way.
In the literature, although modified cross-body posterior stretching seems effective on SIS symptoms there is no research about the comparison of the long-term effects of the traditional and modified static cross-body posterior shoulder stretching exercises in individuals with SIS having GIRD.
Therefore, whether modified stretching is superior to traditional stretching is not known.
Our study aims to investigate and compare the long term effects of the traditional static cross-body posterior shoulder stretching exercise and modified static cross-body posterior shoulder stretching exercise in individuals with SIS having GIRD on shoulder IR ROM, GIRD, PST, pain, external rotation ROM, JPS, subacromial space, supraspinatus tendon thickness, posterior capsule thickness, the occupational ratio of the supraspinatus tendon in the subacromial space, muscle strength and shoulder function and disability level.
Stretching groups will receive either traditional or modified static cross-body posterior shoulder stretching exercise and standard physiotherapy program.
The Control group will receive only sham stretching and standard physiotherapy program.
Standard physiotherapy program consists of electrotherapy, posture, proprioceptive, and strengthening exercises.
The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.
Study Type
Interventional
Enrollment (Estimated)
54
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 Contact
- Name: Halime Ezgi TURKSAN, MSc, PT
- Phone Number: 29396 +902322778714
- Email: hezgi.trksn@gmail.com
Study Contact Backup
- Name: Sevgi Sevi YESİLYAPRAK, PHD, PT
- Phone Number: +902324124926
- Email: sevgi.subasi@deu.edu.tr
Study Locations
-
-
Balçova
-
İzmir, Balçova, Turkey
- Dokuz Eylül University Physical Therapy and Rehabilitation Department
-
-
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
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 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)
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Modified static cross-body posterior shoulder stretching group
The participants will perform active-assistive static stretching in the modified cross-body stretching position.
Additionally, they will receive standard physiotherapy program.
|
For the modified cross-body position patient will be positioned in the side-lying position to limit the scapular abduction, and the patient aligned his/her forearms to limit the ER of the humerus while moving into horizontal adduction (HAdd).
First, we will ask the patient to pull his/her arm into HAdd to the physiological barrier of the ROM, and then the patient will perform active-assistive static stretching with the help of the other hand for 30 seconds.
The stretching will perform five repetitions with 10-sec rest between stretches.
Each stretching will begin from a new physiological barrier of the HAdd ROM.
Patients will also receive the standard physiotherapy program consists of physical agents, posture, proprioceptive, and strengthening exercises.
The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.
|
Experimental: Traditional static cross-body posterior shoulder stretching group
The participants will perform active-assistive static stretching in the traditional standing cross-body stretching position.
Additionally, they will receive standard physiotherapy program.
|
For the traditional static cross-body posterior shoulder stretching, in the standing position, the patient will perform cross-body stretch alone by active-assistive pulling the humerus across the body into HAdd with the opposite arm, without concern for scapular stabilization for 30 sec.
The stretching will perform five repetitions with 10-sec rest between stretches.
Each stretching will begin from a new physiological barrier of the HAdd ROM.
Patients will also receive the standard physiotherapy program consists of physical agents, posture, proprioceptive, and strengthening exercises.
The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.
|
Active Comparator: Control Group
The participants in this group will receive sham stretching and standard physiotherapy.
|
In sham stretching, the patient will be positioned in the traditional static cross body posterior shoulder stretching position, and then the patient will perform active-assistive HAdd ROM without enough stretching of the relevant tissue.
Active assistive ROM will be stopped before reaching the individual PST measurement result (in this way, sham stretching will be performed without proper stretching of the relevant tissue).
The HAdd ROM exercise will be performed 5 times.
Patients will also receive the standard physiotherapy program consists of physical agents, posture, proprioceptive, and strengthening exercises.
The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder internal rotation range of motion
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of shoulder internal rotation range of motion (with bubble inclinometer)
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Glenohumeral internal rotation deficit
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of glenohumeral internal rotation deficit (with bubble inclinometer)
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Posterior shoulder tightness
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of posterior shoulder tightness (with bubble inclinometer)
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Pain intensity
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of visual analog scale score in activity and rest
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Joint position sense
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of shoulder joint repositioning angle errors for external rotation 0-45 degree, for internal rotation 0-45 degree, for scapular plane elevation 0-100 degree (with bubble inclinometer)
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Isometric strength
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of shoulder abduction, internal rotation, and external rotation isometric strength (in kg, with hand held dynamometer)
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Subacromial space
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of subacromial space at neutral (0 degree), 30, 45, and 60-degree scapular plane elevation(with Ultrasound)
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Supraspinatus tendon thickness
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of supraspinatus tendon thickness (with Ultrasound)
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Shoulder external rotation range of motion
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of shoulder external rotation range of motion (with bubble inclinometer)
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Posterior capsule thickness
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of posterior capsule thickness (with Ultrasound)
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Occupational ratio of the supraspinatus tendon in the acromial-humeral space
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of occupational rate of the supraspinatus tendon in the acromial-humeral space
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Shoulder Function
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of Modified Constant-Murley Score
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Upper extremity function
Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks
|
Change of disabilities of the arm, shoulder, and hand (DASH) score
|
Baseline, 8 weeks, 12 weeks, 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sevgi Sevi YESILYAPRAK, PhD, PT, Dokuz Eylül University Physical Therapy and Rehabilitation Department
- Study Director: Onur BAŞÇI, MD, Dokuz Eylül University
- Study Director: Mehmet ERDURAN, MD, Dokuz Eylül University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ludewig PM, Cook TM. Alterations in shoulder kinematics and associated muscle activity in people with symptoms of shoulder impingement. Phys Ther. 2000 Mar;80(3):276-91.
- Wilk KE, Hooks TR, Macrina LC. The modified sleeper stretch and modified cross-body stretch to increase shoulder internal rotation range of motion in the overhead throwing athlete. J Orthop Sports Phys Ther. 2013 Dec;43(12):891-4. doi: 10.2519/jospt.2013.4990. Epub 2013 Oct 30.
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)
September 21, 2021
Primary Completion (Estimated)
September 21, 2024
Study Completion (Estimated)
December 21, 2024
Study Registration Dates
First Submitted
November 28, 2020
First Submitted That Met QC Criteria
December 3, 2020
First Posted (Actual)
December 9, 2020
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 18, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3032-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.
Clinical Trials on Subacromial Impingement Syndrome
-
Mahidol UniversityCompletedSubacromial Impingement Syndrome | Shoulder Impingement Syndrome | Subacromial Pain Syndrome | Subacromial Impingement | Impingement Syndrome, ShoulderIndonesia
-
Central Finland Hospital DistrictOulu University Hospital; Academy of FinlandActive, not recruitingSubacromial Impingement SyndromeFinland
-
Linkoeping UniversityCompletedSubacromial Impingement SyndromeSweden
-
The University of Texas Medical Branch, GalvestonTerminatedSubacromial Impingement Syndrome | Subacromial ImpingementUnited States
-
Sacred Heart UniversityNova Southeastern UniversityCompletedSubacromial Impingement Syndrome | Subacromial Impingement
-
Hvidovre University HospitalRecruitingSubacromial Impingement Syndrome | Subacromial Pain Syndrome | Subacromial ImpingementDenmark
-
Sevgi Medical CenterCompletedSubacromial Impingement Syndrome | Subacromial ImpingementTurkey
-
Cairo UniversityCompletedSubacromial Impingement SyndromeEgypt
-
Universidad Autonoma de Nuevo LeonCompletedSubacromial Impingement Syndrome | Rotator Cuff Impingement Syndrome | Subacromial BursitisMexico
-
CHU de ReimsTerminatedSubacromial Impingement of the ShoulderFrance
Clinical Trials on Modified static cross-body posterior shoulder stretching
-
King Saud UniversityCompletedStiffness of Shoulder, Not Elsewhere ClassifiedSaudi Arabia
-
Universidade Federal de Sao CarlosCompleted
-
Riphah International UniversityCompletedShoulder CapsulitisPakistan
-
Helping Hand Institute of Rehabilitation SciencesCompletedShoulder Pain | Rotator Cuff Tears | Adhesive Capsulitis | Shoulder Impingement | Posterior Capsule Tear | Glenohumeral Subluxation | Glenohumeral Dysplasia | Acromioclavicular; Sprain (Strain) | Internal Rotation Contracture-shoulder | External Rotation Contracture-Shoulder | Flexion Contracture | Extension...Pakistan
-
University of South CarolinaRecruitingHamstring Contractures | Muscle TightnessUnited States
-
Helping Hand Institute of Rehabilitation SciencesCompletedShoulder Pain | Rotator Cuff Tears | Adhesive Capsulitis | Shoulder Impingement | Posterior Capsule Tear | Glenohumeral Subluxation | Glenohumeral Dysplasia | Acromioclavicular; Sprain (Strain) | Internal Rotation Contracture-shoulder | External Rotation Contracture-Shoulder | Flexion Contracture | Extension...Pakistan
-
Helping Hand Institute of Rehabilitation SciencesCompletedShoulder Pain | Rotator Cuff Tears | Adhesive Capsulitis | Shoulder Impingement | Posterior Capsule Tear | Glenohumeral Subluxation | Glenohumeral Dysplasia | Acromioclavicular; Sprain (Strain) | Internal Rotation Contracture-shoulder | External Rotation Contracture-Shoulder | Flexion Contracture | Extension...Pakistan
-
Riphah International UniversityRecruitingOverhead Throwing Athletes | Tennis Players, Bowlers, Volleyball PlayersPakistan
-
Nanyang Technological UniversityNot yet recruiting
-
Shifa Clinical Research CenterCompletedEffect of Low Amplitude Vibration Therapy on Flexibility of Hamstring Muscle in Athletes of PakistanHamstring Contractures | Whole Body VibrationPakistan