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

Primary Purpose

Subacromial Impingement Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Modified static cross-body posterior shoulder stretching
Traditional static cross-body posterior shoulder stretching
Control Group
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring Glenohumeral Internal Rotation Deficit, Modified Cross-body Stretching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Dokuz Eylül University Physical Therapy and Rehabilitation DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Modified static cross-body posterior shoulder stretching group

Traditional static cross-body posterior shoulder stretching group

Control Group

Arm Description

The participants will perform active-assistive static stretching in the modified cross-body stretching position. Additionally, they will receive standard physiotherapy program.

The participants will perform active-assistive static stretching in the traditional standing cross-body stretching position. Additionally, they will receive standard physiotherapy program.

The participants in this group will receive sham stretching and standard physiotherapy.

Outcomes

Primary Outcome Measures

Shoulder internal rotation range of motion
Change of shoulder internal rotation range of motion (with bubble inclinometer)
Glenohumeral internal rotation deficit
Change of glenohumeral internal rotation deficit (with bubble inclinometer)

Secondary Outcome Measures

Posterior shoulder tightness
Change of posterior shoulder tightness (with bubble inclinometer)
Pain intensity
Change of visual analog scale score in activity and rest
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)
Isometric strength
Change of shoulder abduction, internal rotation, and external rotation isometric strength (in kg, with hand held dynamometer)
Subacromial space
Change of subacromial space at neutral (0 degree), 30, 45, and 60-degree scapular plane elevation(with Ultrasound)
Supraspinatus tendon thickness
Change of supraspinatus tendon thickness (with Ultrasound)
Shoulder external rotation range of motion
Change of shoulder external rotation range of motion (with bubble inclinometer)
Posterior capsule thickness
Change of posterior capsule thickness (with Ultrasound)
Occupational ratio of the supraspinatus tendon in the acromial-humeral space
Change of occupational rate of the supraspinatus tendon in the acromial-humeral space
Shoulder Function
Change of Modified Constant-Murley Score
Upper extremity function
Change of disabilities of the arm, shoulder, and hand (DASH) score

Full Information

First Posted
November 28, 2020
Last Updated
October 13, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04660682
Brief Title
A Comparison of the Long Term Effects of the Traditional and Modified Posterior Shoulder Stretching Exercise in Subacromial Impingement Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
September 21, 2024 (Anticipated)
Study Completion Date
December 21, 2024 (Anticipated)

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
Glenohumeral Internal Rotation Deficit, Modified Cross-body Stretching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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, 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
Participant
Masking Description
All of the participants must have subacromial impingement syndrome with glenohumeral internal rotation deficit (Bilateral IRROM difference ≥ 15º )
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified static cross-body posterior shoulder stretching group
Arm Type
Experimental
Arm Description
The participants will perform active-assistive static stretching in the modified cross-body stretching position. Additionally, they will receive standard physiotherapy program.
Arm Title
Traditional static cross-body posterior shoulder stretching group
Arm Type
Experimental
Arm Description
The participants will perform active-assistive static stretching in the traditional standing cross-body stretching position. Additionally, they will receive standard physiotherapy program.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The participants in this group will receive sham stretching and standard physiotherapy.
Intervention Type
Other
Intervention Name(s)
Modified static cross-body posterior shoulder stretching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional static cross-body posterior shoulder stretching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
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 Measure Information:
Title
Shoulder internal rotation range of motion
Description
Change of shoulder internal rotation range of motion (with bubble inclinometer)
Time Frame
Baseline, 8 weeks, 12 weeks, 24 weeks
Title
Glenohumeral internal rotation deficit
Description
Change of glenohumeral internal rotation deficit (with bubble inclinometer)
Time Frame
Baseline, 8 weeks, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Posterior shoulder tightness
Description
Change of posterior shoulder tightness (with bubble inclinometer)
Time Frame
Baseline, 8 weeks, 12 weeks, 24 weeks
Title
Pain intensity
Description
Change of visual analog scale score in activity and rest
Time Frame
Baseline, 8 weeks, 12 weeks, 24 weeks
Title
Joint position sense
Description
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)
Time Frame
Baseline, 8 weeks, 12 weeks, 24 weeks
Title
Isometric strength
Description
Change of shoulder abduction, internal rotation, and external rotation isometric strength (in kg, with hand held dynamometer)
Time Frame
Baseline, 8 weeks, 12 weeks, 24 weeks
Title
Subacromial space
Description
Change of subacromial space at neutral (0 degree), 30, 45, and 60-degree scapular plane elevation(with Ultrasound)
Time Frame
Baseline, 8 weeks, 12 weeks, 24 weeks
Title
Supraspinatus tendon thickness
Description
Change of supraspinatus tendon thickness (with Ultrasound)
Time Frame
Baseline, 8 weeks, 12 weeks, 24 weeks
Title
Shoulder external rotation range of motion
Description
Change of shoulder external rotation range of motion (with bubble inclinometer)
Time Frame
Baseline, 8 weeks, 12 weeks, 24 weeks
Title
Posterior capsule thickness
Description
Change of posterior capsule thickness (with Ultrasound)
Time Frame
Baseline, 8 weeks, 12 weeks, 24 weeks
Title
Occupational ratio of the supraspinatus tendon in the acromial-humeral space
Description
Change of occupational rate of the supraspinatus tendon in the acromial-humeral space
Time Frame
Baseline, 8 weeks, 12 weeks, 24 weeks
Title
Shoulder Function
Description
Change of Modified Constant-Murley Score
Time Frame
Baseline, 8 weeks, 12 weeks, 24 weeks
Title
Upper extremity function
Description
Change of disabilities of the arm, shoulder, and hand (DASH) score
Time Frame
Baseline, 8 weeks, 12 weeks, 24 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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halime Ezgi TURKSAN, MSc, PT
Phone
+902322778714
Ext
29396
Email
hezgi.trksn@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sevgi Sevi YESILYAPRAK, PhD, PT
Phone
+902324124926
Email
sevgi.subasi@deu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevgi Sevi YESILYAPRAK, PhD, PT
Organizational Affiliation
Dokuz Eylul University Physical Therapy and Rehabilitation Department
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
Onur BAŞÇI, MD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
Facility Information:
Facility Name
Dokuz Eylül University Physical Therapy and Rehabilitation Department
City
İzmir
State/Province
Balçova
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halime Ezgi TÜRKSAN
Phone
+902322775030
Email
ezgi-trksn@hotmail.com, hezgi.trksn@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24175603
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.2013.4990. Epub 2013 Oct 30.
Results Reference
result
PubMed Identifier
10696154
Citation
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.
Results Reference
result

Learn more about this trial

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

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