Subacromial Impingement SyndromeNCT06473142
RELATION BETWEEN BODY POSTURE AND SHOULDER DYSFUNCTION
An observational study of Subacromial Impingement Syndrome and Frontal Plane Postural, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study will be to investigate if there is any correlation between shoulder dysfunction and the lateral alignment of the spine, scapular dyskinesia, pelvic tilting angle, Shoulder height angle, and trunk side bending (strength and mobility) in the frontal plane in patients with unilateral SIS. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Subacromial Impingement Syndrome, Frontal Plane Postural
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Aug 2024to 15 Oct 2024
- Phase
- Observational
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Thirty four (34) patients with unilateral SIS. Male and female subjects will be included between 20 and 40 years of age with a BMI between 18.5 to 29.9 kg/m2.
Who may be able to join
- Non-athletic patients of both sexes.
- referred by an orthopedic surgeon with a diagnosis of unilateral SIS (Stage I, or II).
- Patients aged between 20 to 40 years.
- BMI between 18.5 to 29.9 kg/m2.
- having four or more of the following findings:
- Shoulder pain that is located either anteriorly or laterally to the acromion process
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- Pain worsening by shoulder flexion and/or abduction
- A painful movement arc ranging from 60° to 120°
- A palpably painful greater tuberosity of the humerus
- The pain is replicated using the supraspinatus empty-can test, A positive Neer impingement sign, external rotation resistance test, and a positive Hawkins sign.
Who cannot join
- Systematic illnesses
- Pregnancy
- Any degenerative disorder or disc lesion affection of the spine
- A history of upper limb or spinal surgery
- Previous upper limb or spinal fractures
- Post-traumatic shoulder pain
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- History of shoulder instability (positive Sulcus sign, positive apprehension test, and history of shoulder dislocation)
- Clinical signs of cervical radiculopathy (pain related to cervical movements)
- Adhesive capsulitis
- Tumors
- Shoulder labral or cartilage lesions
- Capsular or ligamentous tears or avulsions
- any apparent deformity in the lower limbs including leg length discrepancy.
Trial locations and contacts
1 site in 1 country.
AMR SAAD TAWFIK SOLIMAN, demonstrator contact
Egypt1 site, 1 recruiting
- Recruiting
faculty of physical therapy Cairo university
Cairo
Amr Saad, demonstrator, 01128587378, amrsaadtawfik@cu.edu.eg
Enas Fawzy, professor, 01002043808, enasfawzy@gmail.com
About this study
Official title: CORRELATION BETWEEN SHOULDER DYSFUNCTION AND FRONTAL PLANE POSTURE IN SUBACROMIAL IMPINGEMENT SYNDROME
The purpose of this study will be to investigate if there is any correlation between shoulder dysfunction and the lateral alignment of the spine, scapular dyskinesia, pelvic tilting angle, Shoulder height angle, and trunk side bending (strength and mobility) in the frontal plane in patients with unilateral SIS.
Read the detailed description
This study will be conducted to answer the following question:
Is there any correlation between shoulder dysfunction and the lateral alignment of the spine, scapular dyskinesia, pelvic tilting angle, Shoulder height angle, and trunk side bending (strength and mobility) in the frontal plane in patients with unilateral SIS?
This study will be limited to:
- Thirty four (34) patients with unilateral SIS.
- Male and female subjects will be included between 20 and 40 years of age .
- Shoulder pain and disability level will be measured using the Arabic version of shoulder pain and disability index (SPADI).
- Thoracolumbar lateral deviation will be measured using a scoliometer.
- Scapular dyskinesia will be measured using lateral scapular slide test (LSST).
- The pelvic tilting angle and shoulder height angle will be evaluated using Kinovea software.
- Trunk side bending ROM will be evaluated using a bubble inclinometer .
- Trunk side bending strength will be evaluated using a handheld dynamometer.
Assumptions:
It will be assumed that:
- The instructions given to all individuals will be clear with satisfying explanations for all assessment methods.
- All individuals will follow the instructions.
Hypotheses:
It will be hypothesized that:
- There will be no significant correlation between pain score and measured variables in patients with unilateral SIS:
- lateral spinal deviation
- scapular dyskinesia
- pelvic tilting angle in the frontal plane
- shoulder height angle in the frontal plane
- ipsilateral trunk lateral side bending ROM
- contralateral trunk lateral side bending ROM
- ipsilateral trunk lateral side bending strength
- contralateral trunk lateral side bending strength
- There will be no significant correlation between disability score and measured variables in patients with unilateral SIS:
- lateral spinal deviation
- scapular dyskinesia
- pelvic tilting angle in the frontal plane
- shoulder height angle in the frontal plane
- ipsilateral trunk lateral side bending ROM
- contralateral trunk lateral side bending ROM
- ipsilateral trunk lateral side bending strength
- contralateral trunk lateral side bending strength
- Medical subject headings
- Shoulder Impingement Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracolumbar lateral deviation
will be measured using a scoliometer
Measured: 2 MONTHES
Scapular dyskinesia
will be measured using lateral scapular slide test (LSST)
Measured: 2 monthes
The pelvic tilting angle and shoulder height angle
will be evaluated using Kinovea software
Measured: 2 monthes
Trunk side bending ROM
will be evaluated using a bubble inclinometer
Measured: 2 Monthes
Trunk side bending strength
will be evaluated using a handheld dynamometer
Measured: 2 monthes
Shoulder pain and disability level
will be measured using the Arabic version of shoulder pain and disability index (SPADI)
Measured: 2 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start19 Aug 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Saad Tawfik Soliman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473142
- Sponsor's protocol ID
- P.T.REC/012/005179
- Status last verified
- Aug 2024
- First submitted
- 18 Jun 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I do not have enough information right now
Publications
Bhattacharyya R, Edwards K, Wallace AW. Does arthroscopic sub-acromial decompression really work for sub-acromial impingement syndrome: a cohort study. BMC Musculoskelet Disord. 2014 Sep 29;15:324. doi: 10.1186/1471-2474-15-324.
PubMed 25266967
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORRELATION BETWEEN SHOULDER DYSFUNCTION AND FRONTAL PLANE POSTURE IN SUBACROMIAL IMPINGEMENT SYNDROME
- ClinicalTrials.gov ID
- NCT06473142
- Acronym / sponsor ID
- P.T.REC/012/005179
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 25 Jun 2024 (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 will be to investigate if there is any correlation between shoulder dysfunction and the lateral alignment of the spine, scapular dyskinesia, pelvic tilting angle, Shoulder height angle, and trunk side bending (strength and mobility) in the frontal plane in patients with unilateral SIS.
Detailed description
This study will be conducted to answer the following question:
Is there any correlation between shoulder dysfunction and the lateral alignment of the spine, scapular dyskinesia, pelvic tilting angle, Shoulder height angle, and trunk side bending (strength and mobility) in the frontal plane in patients with unilateral SIS?
This study will be limited to:
- Thirty four (34) patients with unilateral SIS.
- Male and female subjects will be included between 20 and 40 years of age .
- Shoulder pain and disability level will be measured using the Arabic version of shoulder pain and disability index (SPADI).
- Thoracolumbar lateral deviation will be measured using a scoliometer.
- Scapular dyskinesia will be measured using lateral scapular slide test (LSST).
- The pelvic tilting angle and shoulder height angle will be evaluated using Kinovea software.
- Trunk side bending ROM will be evaluated using a bubble inclinometer .
- Trunk side bending strength will be evaluated using a handheld dynamometer.
Assumptions:
It will be assumed that:
- The instructions given to all individuals will be clear with satisfying explanations for all assessment methods.
- All individuals will follow the instructions.
Hypotheses:
It will be hypothesized that:
- There will be no significant correlation between pain score and measured variables in patients with unilateral SIS:
- lateral spinal deviation
- scapular dyskinesia
- pelvic tilting angle in the frontal plane
- shoulder height angle in the frontal plane
- ipsilateral trunk lateral side bending ROM
- contralateral trunk lateral side bending ROM
- ipsilateral trunk lateral side bending strength
- contralateral trunk lateral side bending strength
- There will be no significant correlation between disability score and measured variables in patients with unilateral SIS:
- lateral spinal deviation
- scapular dyskinesia
- pelvic tilting angle in the frontal plane
- shoulder height angle in the frontal plane
- ipsilateral trunk lateral side bending ROM
- contralateral trunk lateral side bending ROM
- ipsilateral trunk lateral side bending strength
- contralateral trunk lateral side bending strength
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Thirty four (34) patients with unilateral SIS. Male and female subjects will be included between 20 and 40 years of age with a BMI between 18.5 to 29.9 kg/m2.
Key inclusion criteria (10 listed)
- Non-athletic patients of both sexes.
- referred by an orthopedic surgeon with a diagnosis of unilateral SIS (Stage I, or II).
- Patients aged between 20 to 40 years.
- BMI between 18.5 to 29.9 kg/m2.
- having four or more of the following findings:
Key exclusion criteria (13 listed)
- Systematic illnesses
- Pregnancy
- Any degenerative disorder or disc lesion affection of the spine
- A history of upper limb or spinal surgery
- Previous upper limb or spinal fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thoracolumbar lateral deviation
Time frame: 2 MONTHES
will be measured using a scoliometer
Scapular dyskinesia
Time frame: 2 monthes
will be measured using lateral scapular slide test (LSST)
The pelvic tilting angle and shoulder height angle
Time frame: 2 monthes
will be evaluated using Kinovea software
Trunk side bending ROM
Time frame: 2 Monthes
will be evaluated using a bubble inclinometer
Trunk side bending strength
Time frame: 2 monthes
will be evaluated using a handheld dynamometer
Shoulder pain and disability level
Time frame: 2 monthes
will be measured using the Arabic version of shoulder pain and disability index (SPADI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Results publication: PubMed 25266967Bhattacharyya R, Edwards K, Wallace AW. Does arthroscopic sub-acromial decompression really work for sub-acromial impingement syndrome: a cohort study. BMC Musculoskelet Disord. 2014 Sep 29;15:324. doi: 10.1186/1471-2474-15-324.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. I do not have enough information right now
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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.
AMR SAAD TAWFIK SOLIMAN, demonstrator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subacromial Impingement Syndrome and Frontal Plane Postural, run by Cairo University at 1 site in Egypt.
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 10 inclusion and 13 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 4 Sep 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 Egypt. 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 AMR SAAD TAWFIK SOLIMAN, demonstrator (+201002043808 ext. 00201002043808, amrsaadtawfik@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracolumbar lateral deviation (time frame: 2 MONTHES). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473142, which also lists 1 linked publication.
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 4 Sep 2024.