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CompletedNCT05996510Updated May 7, 2024

Suprascapular Notch Cross-sectional Area Measured by Ultrasonography

An interventional study of ultrasound in Shoulder Pain and Shoulder Impingement Syndrome, sponsored by Bursa Yüksek İhtisas Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by Bursa Yüksek İhtisas Education and Research Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Shoulder Pain
  • Shoulder Impingement Syndrome
03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Bursa Yüksek İhtisas Education and Research Hospital is the lead sponsor of 62 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • chronic shoulder pain
  • 35-65 years
  • who agreed to participate in the study

Exclusion criteria

Exclusion Criteria:

  • . Lymphoproliferative diseases and other neoplasms
  • .Uncontrolled arterial hypertension
  • Metabolic syndrome
  • Uncontrolled diabetes mellitus
  • Mental retardation
  • Antidepressant use
  • Autoimmune diseases
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    diseased shoulder

    Device: ultrasound

  • Active comparator
    sturdy shoulder

    Device: ultrasound

Interventions

  • Deviceultrasound

    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.

    Also known as: shoulder ultrasound

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

Secondary outcomes

  1. 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.

    Time frame: baseline

  2. 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

    Time frame: baseline

07

Study locations

1 site
  • Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
    Bursa, 16320, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05996510
Lead sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible party
Dr. Burcu Metin Ökmen (Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital) — Principal investigator
First posted
Aug 18, 2023
Start date
Aug 10, 2023
Primary completion
Oct 10, 2023
Completion
Oct 11, 2023
Last update
May 7, 2024

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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