Subacromial Pain SyndromeNCT04813757
Scapular Upward Rotation Focused Treatment for Patient With Shoulder Impingement Syndrome and a Positive Scapular Assistance Test
A study testing exercise and manual therapy in people with Subacromial Pain Syndrome and Impingement Syndrome, run by Meuhedet. Healthcare Organization at 1 site in Israel.
Trial summary
Altered scapular movement is a common impairment among patients with subacromial impingement syndrome (SAIS). Nevertheless scapular focused interventions have resulted in conflicting findings among this population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Pain Syndrome, Impingement Syndrome, Scapular Dyskinesis
- What is being tested?
- exercise and manual therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2020to Dec 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral shoulder pain for ≥1 month
- A diagnosis of SAIS as determined by having 3 or ore positive tests out of: Neer test, Hawkins test, Painful arc, Jobe test, external rotation resistance test.
- A positive SAT
Who cannot join
- Cervical spine involvement as evidenced by reproduction of symptoms with neck movement
- Massive rotator cuff tear as evidenced by pseudoparalysis
- Previous history of a fracture or surgery within the involved shoulder.
- Limited passive range of motion by ≥50% or more compared with uninvolved side in
- 2 planes of motion (i.e. flexion, external rotation)
- A history of shoulder dislocation or subluxation
Show all 10Show fewer
- A history of Rheumatoid arthritis, CVA, fibromyalgia
- Current pregnancy
- Population with special needs
- Pending disability claim / litigation procedure associated with shoulder complaint.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meuhedet
Ashdod
Koni Ben-Simon, B.P.T, 0522763304
Emma Kabakov, M.D
About this study
Official title: Scapular Upward Rotation Focused Treatment for Patients With Shoulder Impingement Syndrome and a Positive Scapular Assistance Test
Altered scapular movement is a common impairment among patients with subacromial impingement syndrome (SAIS). Nevertheless scapular focused interventions have resulted in conflicting findings among this population. One possible reason for this is the inability to identify patients with SAIS who will respond favorably to a scapular focused intervention.
The scapular assistance test (SAT) may be one possible indicator of patients most likely to benefit from a scapular focused intervention, particularly one that emphasizes scapular upward rotation. The purpose of this study is to examine targeted upward rotation intervention in patients demonstrating a positive Scapular Assistance test.
Read the detailed description
Background: Patients with SAIS are commonly referred to physical therapy. A common impairment among patients with SAIS is altered scapular movement, characterized by insufficient upward rotation and posterior tilt. These deficits are believed to decrease the subacromial space and diminish length -tension relationship among the deltoid and rotator cuff musculature. The scapular assistance test (SAT) is a physical examination manoeuvre aimed to detect patients in whom insufficient scapular upward rotation and posterior tilt contribute to the generation of shoulder symptoms. The SAT may, therefore, serve as an indication for the need of scapular focused intervention. Given the inconsistent results of scapular focused interventions among patients with SAIS, the purpose of this study is to assess the outcome of a scapular-focused intervention, particularly geared toward increasing scapular upward rotation, among patients with SAIS that exhibit a positive SAT as well.
Methods: Fifty patients with SAIS and a positive SAT referred to the "Meuhedet" outpatient physical therapy clinic in Ashdod will be recruited for this study. Following baseline assessment, patients will be randomized into 12 sessions over a 6-week period. The intervention group will receive manual therapy and an exercise program focused on increasing scapular upward rotation while the control group will receive manual therapy and an exercise program focused on scapular muscle an rotator cuff strengthening with no special emphasis on scapular upward rotation. Repeated measures analysis of covariance will be conducted to detect differences in pain intensity, shoulder -related disability and scapular upward rotation following the intervention
- Being tested
- exercise, manual therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
each group will perform 2 shoulder strength exercise at the therapy session and 3 exercise at home session-2 strength exercise and one stretching exercise. they will perform the exercises 5 times per week
manual therapyOther
on each treatment session both group will receive 15 minutes of manual therapy which will include: massage,3-4 trigger point treatment posterior capsule stretch and mobilization with movement
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Participants in the intervention group will receive 12 treatment sessions over a 6-week period. Three sessions during the first 2 weeks, 2 sessions per week during weeks 3 and 4 , and one session during weeks 5 and 6. Each session will be 30 minutes including 10 minutes of manual therapy and 20 minutes for review and/or modification of the exercise program. The manual therapy will include trigger point manual therapy. The exercise program will include 2 scapular and rotator cuff strengthening exercises emphasizing scapular upward rotation and posterior tilt and one additional flexibility exercise. These exercise will be repeated at home on the days in between the therapy sessions. Receives: Other: exercise; Other: manual therapy |
| control group | Active comparator | Participants in the control group will receive 12 treatment sessions over a 6-week period. Three sessions during the first 2 weeks, 2 sessions per week during weeks 3 and 4 , and one session during weeks 5 and 6. Each session will be 30 minutes including 10 minutes of manual therapy and 20 minutes for review and/or modification of the exercise program. The manual therapy will include trigger point manual therapy, posterior shoulder stretching, and mobilization-with-movement into shoulder elevation. The exercise program will include 2 exercises focusing on scapular and rotator cuff strengthening without a special emphasis on scapular upward rotation as well as one additional flexibility exercise. These exercises will be performed at home on the days on between the therapy sessions. Receives: Other: exercise; Other: manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability of the Arm, Shoulder and Hand (DASH) questionnaire
each participant will receive the Disability of the Arm shoulder and hand questioner. score is from 0 -100 a higher score is greater disability
Measured: pre intervention
Numeric pain Rating Scale (NPRS), 0 - 10
each participant will receive the NPRS questioner higher score means greater pain
Measured: pre intervention
Secondary outcomes (3)
Active shoulder flexion
in standing position the patient will elevate the arm in the sagittal plane, the range of motion will be measured by goniometer
Measured: pre intervention
active shoulder abduction
in standing position the patient will elevate the arm in the frontal plane, the range of motion will be measured by goniometer
Measured: pre intervention
scapular posterior tilt
in standing position the scapular posterior tilt willl be measured by digital inclinometer which will be placed on the medial border of the scapula. the posterior tilt will be measured in 90 and 120 degree of forward flexion
Measured: pre intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Jul 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Pain 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
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meuhedet. Healthcare Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Ariel University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813757
- Sponsor's protocol ID
- 03-06-11-19
- Status last verified
- Sep 2021
- First submitted
- 20 Dec 2020
- Last updated
- 16 Sep 2021
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scapular Upward Rotation Focused Treatment for Patients With Shoulder Impingement Syndrome and a Positive Scapular Assistance Test
- ClinicalTrials.gov ID
- NCT04813757
- Acronym / sponsor ID
- 03-06-11-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meuhedet. Healthcare OrganizationUniversity, hospital or other
- Collaborators
- Ariel University
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 Mar 2021 (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.
Altered scapular movement is a common impairment among patients with subacromial impingement syndrome (SAIS). Nevertheless scapular focused interventions have resulted in conflicting findings among this population. One possible reason for this is the inability to identify patients with SAIS who will respond favorably to a scapular focused intervention.
The scapular assistance test (SAT) may be one possible indicator of patients most likely to benefit from a scapular focused intervention, particularly one that emphasizes scapular upward rotation. The purpose of this study is to examine targeted upward rotation intervention in patients demonstrating a positive Scapular Assistance test.
Detailed description
Background: Patients with SAIS are commonly referred to physical therapy. A common impairment among patients with SAIS is altered scapular movement, characterized by insufficient upward rotation and posterior tilt. These deficits are believed to decrease the subacromial space and diminish length -tension relationship among the deltoid and rotator cuff musculature. The scapular assistance test (SAT) is a physical examination manoeuvre aimed to detect patients in whom insufficient scapular upward rotation and posterior tilt contribute to the generation of shoulder symptoms. The SAT may, therefore, serve as an indication for the need of scapular focused intervention. Given the inconsistent results of scapular focused interventions among patients with SAIS, the purpose of this study is to assess the outcome of a scapular-focused intervention, particularly geared toward increasing scapular upward rotation, among patients with SAIS that exhibit a positive SAT as well.
Methods: Fifty patients with SAIS and a positive SAT referred to the "Meuhedet" outpatient physical therapy clinic in Ashdod will be recruited for this study. Following baseline assessment, patients will be randomized into 12 sessions over a 6-week period. The intervention group will receive manual therapy and an exercise program focused on increasing scapular upward rotation while the control group will receive manual therapy and an exercise program focused on scapular muscle an rotator cuff strengthening with no special emphasis on scapular upward rotation. Repeated measures analysis of covariance will be conducted to detect differences in pain intensity, shoulder -related disability and scapular upward rotation following the intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: exercise, Other: manual therapyParticipants in the intervention group will receive 12 treatment sessions over a 6-week period. Three sessions during the first 2 weeks, 2 sessions per week during weeks 3 and 4 , and one session during weeks 5 and 6. Each session will be 30 minutes including 10 minutes of manual therapy and 20 minutes for review and/or modification of the exercise program. The manual therapy will include trigger point manual therapy. The exercise program will include 2 scapular and rotator cuff strengthening exercises emphasizing scapular upward rotation and posterior tilt and one additional flexibility exercise. These exercise will be repeated at home on the days in between the therapy sessions. |
| control group | Active comparator | Other: exercise, Other: manual therapyParticipants in the control group will receive 12 treatment sessions over a 6-week period. Three sessions during the first 2 weeks, 2 sessions per week during weeks 3 and 4 , and one session during weeks 5 and 6. Each session will be 30 minutes including 10 minutes of manual therapy and 20 minutes for review and/or modification of the exercise program. The manual therapy will include trigger point manual therapy, posterior shoulder stretching, and mobilization-with-movement into shoulder elevation. The exercise program will include 2 exercises focusing on scapular and rotator cuff strengthening without a special emphasis on scapular upward rotation as well as one additional flexibility exercise. These exercises will be performed at home on the days on between the therapy sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral shoulder pain for ≥1 month
- A diagnosis of SAIS as determined by having 3 or ore positive tests out of: Neer test, Hawkins test, Painful arc, Jobe test, external rotation resistance test.
- A positive SAT
Key exclusion criteria (10 listed)
- Cervical spine involvement as evidenced by reproduction of symptoms with neck movement
- Massive rotator cuff tear as evidenced by pseudoparalysis
- Previous history of a fracture or surgery within the involved shoulder.
- Limited passive range of motion by ≥50% or more compared with uninvolved side in
- A history of shoulder dislocation or subluxation
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 |
|---|---|---|
| exerciseeach group will perform 2 shoulder strength exercise at the therapy session and 3 exercise at home session-2 strength exercise and one stretching exercise. they will perform the exercises 5 times per week | Other | control group, intervention group |
| manual therapyon each treatment session both group will receive 15 minutes of manual therapy which will include: massage,3-4 trigger point treatment posterior capsule stretch and mobilization with movement | Other | control group, intervention group |
Primary outcome
Disability of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: pre intervention
each participant will receive the Disability of the Arm shoulder and hand questioner. score is from 0 -100 a higher score is greater disability
Numeric pain Rating Scale (NPRS), 0 - 10
Time frame: pre intervention
each participant will receive the NPRS questioner higher score means greater pain
3 secondary outcomes
Active shoulder flexion
Time frame: pre intervention
active shoulder abduction
Time frame: pre intervention
scapular posterior tilt
Time frame: pre intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and manual therapy in people with Subacromial Pain Syndrome and Impingement Syndrome, run by Meuhedet. Healthcare Organization at 1 site in Israel.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 16 Sep 2021. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrey Maizles (0547664393, maizles1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability of the Arm, Shoulder and Hand (DASH) questionnaire (time frame: pre intervention). 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 16 Sep 2021.