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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04660682
Other study ID # 3032-GOA
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 21, 2021
Est. completion date December 21, 2024

Study information

Verified date February 2024
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 54
Est. completion date December 21, 2024
Est. primary completion date September 21, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 ยบ - 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 Design


Intervention

Other:
Modified static cross-body posterior shoulder stretching
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.
Traditional static cross-body posterior shoulder stretching
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.
Control Group
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.

Locations

Country Name City State
Turkey Dokuz Eylül University Physical Therapy and Rehabilitation Department Izmir Balçova

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Shoulder internal rotation range of motion Change of shoulder internal rotation range of motion (with bubble inclinometer) Baseline, 8 weeks, 12 weeks, 24 weeks
Primary Glenohumeral internal rotation deficit Change of glenohumeral internal rotation deficit (with bubble inclinometer) Baseline, 8 weeks, 12 weeks, 24 weeks
Secondary Posterior shoulder tightness Change of posterior shoulder tightness (with bubble inclinometer) Baseline, 8 weeks, 12 weeks, 24 weeks
Secondary Pain intensity Change of visual analog scale score in activity and rest Baseline, 8 weeks, 12 weeks, 24 weeks
Secondary Joint position sense 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
Secondary Isometric strength Change of shoulder abduction, internal rotation, and external rotation isometric strength (in kg, with hand held dynamometer) Baseline, 8 weeks, 12 weeks, 24 weeks
Secondary Subacromial space 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
Secondary Supraspinatus tendon thickness Change of supraspinatus tendon thickness (with Ultrasound) Baseline, 8 weeks, 12 weeks, 24 weeks
Secondary Shoulder external rotation range of motion Change of shoulder external rotation range of motion (with bubble inclinometer) Baseline, 8 weeks, 12 weeks, 24 weeks
Secondary Posterior capsule thickness Change of posterior capsule thickness (with Ultrasound) Baseline, 8 weeks, 12 weeks, 24 weeks
Secondary Occupational ratio of the supraspinatus tendon in the acromial-humeral space Change of occupational rate of the supraspinatus tendon in the acromial-humeral space Baseline, 8 weeks, 12 weeks, 24 weeks
Secondary Shoulder Function Change of Modified Constant-Murley Score Baseline, 8 weeks, 12 weeks, 24 weeks
Secondary Upper extremity function Change of disabilities of the arm, shoulder, and hand (DASH) score Baseline, 8 weeks, 12 weeks, 24 weeks
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