AzTrials
AzTrials

Subacromial Impingement SyndromeNCT04660682

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

A study testing Modified static cross-body posterior shoulder stretching and Traditional static cross-body posterior shoulder stretching in people with Subacromial Impingement Syndrome, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Subacromial Impingement Syndrome
What is being tested?
Modified static cross-body posterior shoulder stretching and Traditional static cross-body posterior shoulder stretching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Sep 2021to 21 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dokuz Eylül University Physical Therapy and Rehabilitation Department

    Izmir, Balçova

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Modified static cross-body posterior shoulder stretching, Traditional static cross-body posterior shoulder stretching, Control Group
Keywords
Glenohumeral Internal Rotation Deficit, Modified Cross-body Stretching
Medical subject headings
Shoulder Impingement Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified static cross-body posterior shoulder stretchingOther

    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 stretchingOther

    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 GroupOther

    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.

Study groups in NCT04660682
Study groupRoleWhat they receive
Modified static cross-body posterior shoulder stretching groupExperimentalThe participants will perform active-assistive static stretching in the modified cross-body stretching position. Additionally, they will receive standard physiotherapy program.
Receives: Other: Modified static cross-body posterior shoulder stretching
Traditional static cross-body posterior shoulder stretching groupExperimentalThe participants will perform active-assistive static stretching in the traditional standing cross-body stretching position. Additionally, they will receive standard physiotherapy program.
Receives: Other: Traditional static cross-body posterior shoulder stretching
Control GroupActive comparatorThe participants in this group will receive sham stretching and standard physiotherapy.
Receives: Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Shoulder internal rotation range of motion

    Change of shoulder internal rotation range of motion (with bubble inclinometer)

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

  2. Glenohumeral internal rotation deficit

    Change of glenohumeral internal rotation deficit (with bubble inclinometer)

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

Secondary outcomes (11)
  1. Posterior shoulder tightness

    Change of posterior shoulder tightness (with bubble inclinometer)

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

  2. Pain intensity

    Change of visual analog scale score in activity and rest

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

  3. 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)

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

  4. Isometric strength

    Change of shoulder abduction, internal rotation, and external rotation isometric strength (in kg, with hand held dynamometer)

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

  5. Subacromial space

    Change of subacromial space at neutral (0 degree), 30, 45, and 60-degree scapular plane elevation(with Ultrasound)

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

  6. Supraspinatus tendon thickness

    Change of supraspinatus tendon thickness (with Ultrasound)

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

  7. Shoulder external rotation range of motion

    Change of shoulder external rotation range of motion (with bubble inclinometer)

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

  8. Posterior capsule thickness

    Change of posterior capsule thickness (with Ultrasound)

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

  9. Occupational ratio of the supraspinatus tendon in the acromial-humeral space

    Change of occupational rate of the supraspinatus tendon in the acromial-humeral space

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

  10. Shoulder Function

    Change of Modified Constant-Murley Score

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

  11. Upper extremity function

    Change of disabilities of the arm, shoulder, and hand (DASH) score

    Measured: Baseline, 8 weeks, 12 weeks, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start21 Sep 2021
  3. Primary completion21 Sep 2024
  4. Study completion21 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04660682
Sponsor's protocol ID
3032-GOA
Status last verified
Nov 2024
First submitted
28 Nov 2020
Last updated
5 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Modified static cross-body posterior shoulder stretching and Traditional static cross-body posterior shoulder stretching in people with Subacromial Impingement Syndrome, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder internal rotation range of motion (time frame: Baseline, 8 weeks, 12 weeks, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in