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A Comparison of the Long Term Effects of the Traditional and Modified Posterior Shoulder Stretching Exercise in Subacromial Impingement Syndrome

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ClinicalTrials.gov Identifier: NCT04660682
Recruitment Status : Not yet recruiting
First Posted : December 9, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Halime Ezgi TÜRKSAN, Dokuz Eylul University

Brief 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.

Condition or disease Intervention/treatment Phase
Subacromial Impingement Syndrome Other: Modified static cross-body posterior shoulder stretching Other: Traditional static cross-body posterior shoulder stretching Other: Control Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There are 3 groups. The first group will receive the modified static cross-body posterior shoulder stretching and the standard physiotherapy program. The second group will receive traditional static cross-body posterior shoulder stretching and the standard physiotherapy program. The Control group will receive sham stretching and the standard physiotherapy program. In standard physiotherapy program, there are TENS, hot-pack, cold-pack, posture, proprioceptive, and strengthening training. The treatment program will last for eight weeks. Patients will receive the treatment program 5 days a week under the physiotherapist's supervision and 2 days a week as a home program.
Masking: Single (Participant)
Masking Description: All of the participants must have subacromial impingement syndrome with glenohumeral internal rotation deficit (Bilateral IRROM difference ≥ 15º )
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : September 21, 2021
Estimated Primary Completion Date : September 21, 2024
Estimated Study Completion Date : December 21, 2024

Resource links provided by the National Library of Medicine


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.
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.

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.
Other: 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.

Active Comparator: Control Group
The participants in this group will receive sham stretching and standard physiotherapy.
Other: 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.




Primary Outcome Measures :
  1. 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)

  2. Glenohumeral internal rotation deficit [ Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks ]
    Change of glenohumeral internal rotation deficit (with bubble inclinometer)


Secondary Outcome Measures :
  1. Posterior shoulder tightness [ Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks ]
    Change of posterior shoulder tightness (with bubble inclinometer)

  2. Pain intensity [ Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks ]
    Change of visual analog scale score in activity and rest

  3. Joint position sense [ Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks ]
    Change of shoulder joint repositioning angle errors (with bubble inclinometer)

  4. 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)

  5. Eccentric strength [ Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks ]
    Change of shoulder abduction eccentric strength (in kg, with hand held dynamometer)

  6. Subacromial space [ Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks ]
    Change of subacromial space (with Ultrasound)

  7. Supraspinatus tendon thickness [ Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks ]
    Change of supraspinatus tendon thickness (with Ultrasound)

  8. 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)

  9. Posterior capsule thickness [ Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks ]
    Change of posterior capsule thickness (with Ultrasound)

  10. 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

  11. Shoulder Function [ Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks ]
    Change of Modified Constant-Murley Score

  12. Upper extremity function [ Time Frame: Baseline, 8 weeks, 12 weeks, 24 weeks ]
    Change of disabilities of the arm, shoulder, and hand (Quick-DASH) score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • An inability to elevate the involved arm greater than 140 degree in the scapular plane
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04660682


Contacts
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Contact: Halime Ezgi TURKSAN, MSc, PT +902322778714 ext 29396 hezgi.trksn@gmail.com
Contact: Sevgi Sevi YESILYAPRAK, PhD, PT +902324124926 sevgi.subasi@deu.edu.tr

Sponsors and Collaborators
Dokuz Eylul University
Investigators
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Study Director: Sevgi Sevi YESILYAPRAK, PhD, PT Dokuz Eylul University
Study Director: Mehmet ERDURAN, MD Dokuz Eylul University
Study Director: Onur BAŞÇI, MD Dokuz Eylul University
Publications of Results:
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Responsible Party: Halime Ezgi TÜRKSAN, MSc, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT04660682    
Other Study ID Numbers: 3032-GOA
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Halime Ezgi TÜRKSAN, Dokuz Eylul University:
Glenohumeral Internal Rotation Deficit, Modified Cross-body Stretching
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Syndrome
Rotator Cuff Injuries
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases