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).
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
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.
- Conditions
- Subacromial Impingement Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| Modified static cross-body posterior shoulder stretching group | Experimental | The 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 group | Experimental | The 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 Group | Active comparator | The 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.
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
Glenohumeral internal rotation deficit
Change of glenohumeral internal rotation deficit (with bubble inclinometer)
Measured: Baseline, 8 weeks, 12 weeks, 24 weeks
Secondary outcomes (11)
Posterior shoulder tightness
Change of posterior shoulder tightness (with bubble inclinometer)
Measured: Baseline, 8 weeks, 12 weeks, 24 weeks
Pain intensity
Change of visual analog scale score in activity and rest
Measured: Baseline, 8 weeks, 12 weeks, 24 weeks
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
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
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
Supraspinatus tendon thickness
Change of supraspinatus tendon thickness (with Ultrasound)
Measured: Baseline, 8 weeks, 12 weeks, 24 weeks
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
Posterior capsule thickness
Change of posterior capsule thickness (with Ultrasound)
Measured: Baseline, 8 weeks, 12 weeks, 24 weeks
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
Shoulder Function
Change of Modified Constant-Murley Score
Measured: Baseline, 8 weeks, 12 weeks, 24 weeks
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.
- First posted9 Dec 2020
- Study start21 Sep 2021
- Primary completion21 Sep 2024
- Study completion21 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime Ezgi TÜRKSAN, Dokuz Eylul University
- Investigators
- Sevgi Sevi YESILYAPRAK, PhD, PT, Study director, Dokuz Eylul University Physical Therapy and Rehabilitation DepartmentMehmet ERDURAN, MD, Study director, Dokuz Eylul UniversityOnur BAŞÇI, MD, Study director, Dokuz Eylul University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04660682
- Acronym / sponsor ID
- 3032-GOA
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Glenohumeral Internal Rotation Deficit, Modified Cross-body Stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 21 Sep 2024 (actual)
- Study completion
- 21 Sep 2024 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Modified static cross-body posterior shoulder stretching group | Experimental | Other: Modified static cross-body posterior shoulder stretchingThe participants will perform active-assistive static stretching in the modified cross-body stretching position. Additionally, they will receive standard physiotherapy program. |
| Traditional static cross-body posterior shoulder stretching group | Experimental | Other: Traditional static cross-body posterior shoulder stretchingThe participants will perform active-assistive static stretching in the traditional standing cross-body stretching position. Additionally, they will receive standard physiotherapy program. |
| Control Group | Active comparator | Other: Control GroupThe participants in this group will receive sham stretching and standard physiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified static cross-body posterior shoulder stretchingFor 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. | Other | Modified static cross-body posterior shoulder stretching group |
| Traditional static cross-body posterior shoulder stretchingFor 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. | Other | Traditional static cross-body posterior shoulder stretching group |
| Control GroupIn 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. | Other | Control Group |
Primary outcome
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)
Glenohumeral internal rotation deficit
Time frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Change of glenohumeral internal rotation deficit (with bubble inclinometer)
11 secondary outcomes
Posterior shoulder tightness
Time frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Pain intensity
Time frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Joint position sense
Time frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Isometric strength
Time frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Subacromial space
Time frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Supraspinatus tendon thickness
Time frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Shoulder external rotation range of motion
Time frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Posterior capsule thickness
Time frame: 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
Shoulder Function
Time frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Upper extremity function
Time frame: Baseline, 8 weeks, 12 weeks, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevgi Sevi YESILYAPRAK, PhD, PT study director
Dokuz Eylul University Physical Therapy and Rehabilitation Department
Mehmet ERDURAN, MD study director
Dokuz Eylul University
Onur BAŞÇI, MD study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
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.