Shoulder PainNCT05996510
Suprascapular Notch Cross-sectional Area Measured by Ultrasonography
A study testing ultrasound in people with Shoulder Pain and Shoulder Impingement Syndrome, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronic shoulder pain is one of the most common diseases affecting the quality of life today. Although there are multiple causes, one of the most common causes is shoulder impingement syndrome. Ultrasound can be used for diagnosis in patients whose treatment is difficult due to its complex structure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain, Shoulder Impingement Syndrome
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2023to 11 Oct 2023
- 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
- chronic shoulder pain
- 35-65 years
- who agreed to participate in the study
Who cannot join
- . Lymphoproliferative diseases and other neoplasms
- .Uncontrolled arterial hypertension
- Metabolic syndrome
- Uncontrolled diabetes mellitus
- Mental retardation
- Antidepressant use
- Autoimmune diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa, 16320
About this study
Official title: Investigation of the Relationship Between Suprascapular Notch Cross-sectional Area Measured by Ultrasonography and Disease Activity in Subacromial Impingement Syndrome
Chronic shoulder pain is one of the most common diseases affecting the quality of life today. Although there are multiple causes, one of the most common causes is shoulder impingement syndrome.
Ultrasound can be used for diagnosis in patients whose treatment is difficult due to its complex structure. While the supraspinatus muscle, tendon and shoulder joint are the regions that are usually evaluated, the visualization of the Suprascapular notch is usually observed during injection. The connection between the suprascapular notch and the shoulder joint has been demonstrated in different studies.
Read the detailed description
In this study, the investigation of the relationship between the measurements of the suprascapular nerve and the suprascapular notch, which the investigators observed in our clinical ultrasound applications, and the disease activity intended.
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome
- Being tested
- ultrasound
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
Also called shoulder ultrasound
Shoulder ultrasound is performed using a linear ultrasound probe. The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
| Study group | Role | What they receive |
|---|---|---|
| diseased shoulder | Active comparator | Not described Receives: Device: ultrasound |
| sturdy shoulder | Active comparator | Not described Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suprascapular notch cross-sectional area measurement
The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
Measured: baseline
Secondary outcomes (2)
Visual Analogue Scale
Visual Analog Scale was used for pain. Pain intensity was measured using 0-10 cm visual analogue scale (VAS). The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
Measured: baseline
Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items.To score either version of the SPADI, the total score is calculated by averaging the pain and disability subscale scores to find a score out of 100. On this scale, 0 represents less disability while 100 represents greatest disability
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start10 Aug 2023
- Primary completion10 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Burcu Metin Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- korgün ökmen, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalLale altan inceoğlu, phd, Study chair, uludağ university faculty of medicineugur ertem, M.D., Study chair, uludağ university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996510
- Sponsor's protocol ID
- BursaYIEAH
- Status last verified
- May 2024
- First submitted
- 4 Aug 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Suprascapular Notch Cross-sectional Area Measured by Ultrasonography and Disease Activity in Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT05996510
- Acronym / sponsor ID
- BursaYIEAH
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 18 Aug 2023 (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.
Chronic shoulder pain is one of the most common diseases affecting the quality of life today. Although there are multiple causes, one of the most common causes is shoulder impingement syndrome.
Ultrasound can be used for diagnosis in patients whose treatment is difficult due to its complex structure. While the supraspinatus muscle, tendon and shoulder joint are the regions that are usually evaluated, the visualization of the Suprascapular notch is usually observed during injection. The connection between the suprascapular notch and the shoulder joint has been demonstrated in different studies.
Detailed description
In this study, the investigation of the relationship between the measurements of the suprascapular nerve and the suprascapular notch, which the investigators observed in our clinical ultrasound applications, and the disease activity intended.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diseased shoulder | Active comparator | Device: ultrasound |
| sturdy shoulder | Active comparator | Device: ultrasound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic shoulder pain
- 35-65 years
- who agreed to participate in the study
Key exclusion criteria (7 listed)
- . Lymphoproliferative diseases and other neoplasms
- .Uncontrolled arterial hypertension
- Metabolic syndrome
- Uncontrolled diabetes mellitus
- Mental retardation
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 |
|---|---|---|
| ultrasoundAlso: shoulder ultrasoundShoulder ultrasound is performed using a linear ultrasound probe. The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method. | Device | diseased shoulder, sturdy shoulder |
Primary outcome
Suprascapular notch cross-sectional area measurement
Time frame: baseline
The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
2 secondary outcomes
Visual Analogue Scale
Time frame: baseline
Shoulder Pain and Disability Index (SPADI)
Time frame: baseline
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 7 May 2024.
- Individual participant dataSharing planned: No
Related trials for Shoulder Pain
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Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
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Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
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Subacromial Impingement Syndrome
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.
korgün ökmen study chair
Bursa Yuksek Ihtisas Training and Research Hospital
Lale altan inceoğlu, phd study chair
uludağ university faculty of medicine
ugur ertem, M.D. study chair
uludağ university faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound in people with Shoulder Pain and Shoulder Impingement Syndrome, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 3 inclusion and 7 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 7 May 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?
Suprascapular notch cross-sectional area measurement (time frame: baseline). 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 7 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.