Subacromial ImpingementNCT04759027
Reliability of the Subacromial Distance Measurements With Standard Radiographic Imaging
An observational study of Subacromial Impingement and Rotator Cuff Tears, run by Göker Utku değer at 1 site in Turkey (Türkiye).
Trial summary
Patients with complaints of shoulder pain or limitation of motion, who admitted to outpatient orthopaedic clinic will be analyzed. It was planned to measure the subacromial distance using standardized both shoulder ap, true ap and outlet radiographs, and ultrasound to be performed for shoulder circumference soft… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement, Rotator Cuff Tears
- What is being tested?
- subacromial distance measurement
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients over the age of 18 who admitted to orthopedics and traumatology outpatient clinics with a complaint of non-traumatic shoulder pain for more than two weeks or traumatic shoulder pain will be study population.
Who may be able to join
- shoulder pain ( acute traumatic or non-traumatic chronic)
Who cannot join
- end stage glenohumeral joint arthrosis
- adhesive capsulitis
- fractures
- previous shoulder surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty
Istanbul, 34098
About this study
Official title: Prospective Evaluation of the Reliability and Re-applicability of Subacromial Distance Measurement With Standard Radiographic Imaging Compared to Ultrasound Imaging
Patients with complaints of shoulder pain or limitation of motion, who admitted to outpatient orthopaedic clinic will be analyzed. It was planned to measure the subacromial distance using standardized both shoulder ap, true ap and outlet radiographs, and ultrasound to be performed for shoulder circumference soft tissue and muscle-tendon evaluation. The measurement made by the physical therapy and rehabilitation specialist with ultrasound will be considered to be accurate, and it was planned to evaluate the reliability of the graphy measurements by comparing this measurement with the measurements in the graphs. In addition, it was planned to evaluate the intra-observer and inter-observer compliance by re-measuring the subacromial distance on the radiograph by orthopedic doctors of three different seniority levels with an interval of one month.
Read the detailed description
Rotator cuff injuries are the most common injury to the shoulder girdle. Patients present to the clinic with shoulder compression at an early age and with tears in older ages. Nearly 50% of the population can be torn in advanced ages. Repetitive trauma caused by overuse is blamed for rotator cuff tears. The narrowing of the subacromial distance causes compression in the anterior, tears and enlargement of the tears by extrinsic mechanism. In addition, the surgery to be performed according to the subacromial distance and the benefit to the patient from this surgery can be predicted. In studies conducted in normal population, subacromial distance was reported to be between 6-12 mm, measurements made under 6-7 mm were evaluated as pathologically and were defined as tears that would not benefit from repair.
The reliability of this measurement, which guides the diagnosis and treatment, is important. The diagnosis of these diseases is made by imaging methods following the physical examination and then the decision of the appropriate treatment method is made. It is known that conventional radiographs constitute the first step of evaluation as a standard in almost all patients in orthopedic practice. Magnetic resonance imaging and ultrasound are often preferred for shoulder, shoulder circumference pathology and injuries, in relation to the examination findings after direct radiography at the diagnosis and examination stage. Drawing graphs on both shoulders from these images to provide comparative evaluation provides more detailed information in evaluation. The subacromial distance or acromiohumeral distance used in the evaluation of rotator cuff pathologies was defined as the shortest distance between the sclerotic inferior border of the acromion and the humeral head. The measurement of this distance can be made with direct graphy, mri, ct, and ultrasound. In the only systematic review on this subject, it was emphasized that this measurement can be made with ultrasound as the most reliable, and the evaluations made by direct radiography are worthless. In these inferences, the poor methodology of the studies made using direct graphy measurement was shown as the reason. Many studies have been carried out by standardizing the imaging, its importance has been proven by the inconsistent results of the study with non-standardized graphs.
- Conditions
- Subacromial Impingement, Rotator Cuff Tears
- Being tested
- subacromial distance measurement
- Keywords
- x-ray, direct radiography, ultrasound, acromiohumeral distance, subacromial distance, rotator cuff
- Medical subject headings
- Shoulder Impingement Syndrome, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subacromial distance measurementOther
distance between acromion and humerus
| Study group | Role | What they receive |
|---|---|---|
| X-ray | Measurements of subacromial distance on standardized direct radiography Receives: Other: subacromial distance measurement | |
| ultrasound | Measurements of subacromial distance on ultrasound Receives: Other: subacromial distance measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
RELIABILITY OF DIRECT RADIOGRAPHY IMAGING
The investigators will compare the results of subacromial distance measure on X-ray and ultrasound. Ultrasound measures were accepted as gold standart method.
Measured: within 2 weeks after first evaluation
Secondary outcomes (1)
REPRODUCIBLITY
if X-ray measurements will correlate with ultrasound, the investigators will evaluate intraobserver and interobserver measurement differences
Measured: 1 month apart measurements will be evaluate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 May 2021
- Primary completion31 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Subacromial ImpingementStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göker Utku değer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Göker Utku değer, Istanbul University - Cerrahpasa
- Investigators
- Mehmet F Guven, Assoc.prof, Study director, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759027
- Sponsor's protocol ID
- E-83045809-604.01.02-1214
- Status last verified
- Mar 2022
- First submitted
- 1 Feb 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
PubMed 15163107Tempelhof S, Rupp S, Seil R. Age-related prevalence of rotator cuff tears in asymptomatic shoulders. J Shoulder Elbow Surg. 1999 Jul-Aug;8(4):296-9. doi: 10.1016/s1058-2746(99)90148-9.
PubMed 10471998Yamamoto A, Takagishi K, Osawa T, Yanagawa T, Nakajima D, Shitara H, Kobayashi T. Prevalence and risk factors of a rotator cuff tear in the general population. J Shoulder Elbow Surg. 2010 Jan;19(1):116-20. doi: 10.1016/j.jse.2009.04.006.
PubMed 19540777Azzoni R, Cabitza P, Parrini M. Sonographic evaluation of subacromial space. Ultrasonics. 2004 Apr;42(1-9):683-7. doi: 10.1016/j.ultras.2003.11.015.
PubMed 15047367Saupe N, Pfirrmann CW, Schmid MR, Jost B, Werner CM, Zanetti M. Association between rotator cuff abnormalities and reduced acromiohumeral distance. AJR Am J Roentgenol. 2006 Aug;187(2):376-82. doi: 10.2214/AJR.05.0435.
PubMed 16861541Schmidt WA, Schmidt H, Schicke B, Gromnica-Ihle E. Standard reference values for musculoskeletal ultrasonography. Ann Rheum Dis. 2004 Aug;63(8):988-94. doi: 10.1136/ard.2003.015081.
PubMed 15249327Norwood LA, Barrack R, Jacobson KE. Clinical presentation of complete tears of the rotator cuff. J Bone Joint Surg Am. 1989 Apr;71(4):499-505.
PubMed 2703509Ellman H, Hanker G, Bayer M. Repair of the rotator cuff. End-result study of factors influencing reconstruction. J Bone Joint Surg Am. 1986 Oct;68(8):1136-44.
PubMed 3771595Kum DH, Kim JH, Park KM, Lee ES, Park YB, Yoo JC. Acromion Index in Korean Population and Its Relationship with Rotator Cuff Tears. Clin Orthop Surg. 2017 Jun;9(2):218-222. doi: 10.4055/cios.2017.9.2.218. Epub 2017 May 8.
PubMed 28567226Mayerhoefer ME, Breitenseher MJ, Wurnig C, Roposch A. Shoulder impingement: relationship of clinical symptoms and imaging criteria. Clin J Sport Med. 2009 Mar;19(2):83-9. doi: 10.1097/JSM.0b013e318198e2e3.
PubMed 19451760Werner CM, Conrad SJ, Meyer DC, Keller A, Hodler J, Gerber C. Intermethod agreement and interobserver correlation of radiologic acromiohumeral distance measurements. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):237-40. doi: 10.1016/j.jse.2007.06.002. Epub 2007 Dec 26.
PubMed 18162412Sasiponganan C, Dessouky R, Ashikyan O, Pezeshk P, McCrum C, Xi Y, Chhabra A. Subacromial impingement anatomy and its association with rotator cuff pathology in women: radiograph and MRI correlation, a retrospective evaluation. Skeletal Radiol. 2019 May;48(5):781-790. doi: 10.1007/s00256-018-3096-0. Epub 2018 Oct 27.
PubMed 30368566Yoshida Y, Matsumura N, Yamada Y, Yamada M, Yokoyama Y, Matsumoto M, Nakamura M, Nagura T, Jinzaki M. Evaluation of three-dimensional acromiohumeral distance in the standing position and comparison with its conventional measuring methods. J Orthop Surg Res. 2020 Sep 23;15(1):436. doi: 10.1186/s13018-020-01935-9.
PubMed 32967710van de Sande MA, Rozing PM. Proximal migration can be measured accurately on standardized anteroposterior shoulder radiographs. Clin Orthop Relat Res. 2006 Feb;443:260-5. doi: 10.1097/01.blo.0000196043.34789.73.
PubMed 16462449Ueda Y, Tanaka H, Tomita K, Tachibana T, Inui H, Nobuhara K, Umehara J, Ichihashi N. Comparison of shoulder muscle strength, cross-sectional area, acromiohumeral distance, and thickness of the supraspinatus tendon between symptomatic and asymptomatic patients with rotator cuff tears. J Shoulder Elbow Surg. 2020 Oct;29(10):2043-2050. doi: 10.1016/j.jse.2020.02.017. Epub 2020 May 26.
PubMed 32471753
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Reliability and Re-applicability of Subacromial Distance Measurement With Standard Radiographic Imaging Compared to Ultrasound Imaging
- ClinicalTrials.gov ID
- NCT04759027
- Acronym / sponsor ID
- E-83045809-604.01.02-1214
- Conditions
- Subacromial Impingement, Rotator Cuff Tears
- Keywords
- x-ray, direct radiography, ultrasound, acromiohumeral distance, subacromial distance, rotator cuff
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Göker Utku değerUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 17 Feb 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.
Patients with complaints of shoulder pain or limitation of motion, who admitted to outpatient orthopaedic clinic will be analyzed. It was planned to measure the subacromial distance using standardized both shoulder ap, true ap and outlet radiographs, and ultrasound to be performed for shoulder circumference soft tissue and muscle-tendon evaluation. The measurement made by the physical therapy and rehabilitation specialist with ultrasound will be considered to be accurate, and it was planned to evaluate the reliability of the graphy measurements by comparing this measurement with the measurements in the graphs. In addition, it was planned to evaluate the intra-observer and inter-observer compliance by re-measuring the subacromial distance on the radiograph by orthopedic doctors of three different seniority levels with an interval of one month.
Detailed description
Rotator cuff injuries are the most common injury to the shoulder girdle. Patients present to the clinic with shoulder compression at an early age and with tears in older ages. Nearly 50% of the population can be torn in advanced ages. Repetitive trauma caused by overuse is blamed for rotator cuff tears. The narrowing of the subacromial distance causes compression in the anterior, tears and enlargement of the tears by extrinsic mechanism. In addition, the surgery to be performed according to the subacromial distance and the benefit to the patient from this surgery can be predicted. In studies conducted in normal population, subacromial distance was reported to be between 6-12 mm, measurements made under 6-7 mm were evaluated as pathologically and were defined as tears that would not benefit from repair.
The reliability of this measurement, which guides the diagnosis and treatment, is important. The diagnosis of these diseases is made by imaging methods following the physical examination and then the decision of the appropriate treatment method is made. It is known that conventional radiographs constitute the first step of evaluation as a standard in almost all patients in orthopedic practice. Magnetic resonance imaging and ultrasound are often preferred for shoulder, shoulder circumference pathology and injuries, in relation to the examination findings after direct radiography at the diagnosis and examination stage. Drawing graphs on both shoulders from these images to provide comparative evaluation provides more detailed information in evaluation. The subacromial distance or acromiohumeral distance used in the evaluation of rotator cuff pathologies was defined as the shortest distance between the sclerotic inferior border of the acromion and the humeral head. The measurement of this distance can be made with direct graphy, mri, ct, and ultrasound. In the only systematic review on this subject, it was emphasized that this measurement can be made with ultrasound as the most reliable, and the evaluations made by direct radiography are worthless. In these inferences, the poor methodology of the studies made using direct graphy measurement was shown as the reason. Many studies have been carried out by standardizing the imaging, its importance has been proven by the inconsistent results of the study with non-standardized graphs.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| X-ray | – | Other: subacromial distance measurementMeasurements of subacromial distance on standardized direct radiography |
| ultrasound | – | Other: subacromial distance measurementMeasurements of subacromial distance on ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over the age of 18 who admitted to orthopedics and traumatology outpatient clinics with a complaint of non-traumatic shoulder pain for more than two weeks or traumatic shoulder pain will be study population.
Key inclusion criteria (1 listed)
- shoulder pain ( acute traumatic or non-traumatic chronic)
Key exclusion criteria (4 listed)
- end stage glenohumeral joint arthrosis
- adhesive capsulitis
- fractures
- previous 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 |
|---|---|---|
| subacromial distance measurementdistance between acromion and humerus | Other | X-ray, ultrasound |
Primary outcome
RELIABILITY OF DIRECT RADIOGRAPHY IMAGING
Time frame: within 2 weeks after first evaluation
The investigators will compare the results of subacromial distance measure on X-ray and ultrasound. Ultrasound measures were accepted as gold standart method.
1 secondary outcome
REPRODUCIBLITY
Time frame: 1 month apart measurements will be evaluate
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 31 Mar 2022.
- Background: PubMed 15163107Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
- Background: PubMed 10471998Tempelhof S, Rupp S, Seil R. Age-related prevalence of rotator cuff tears in asymptomatic shoulders. J Shoulder Elbow Surg. 1999 Jul-Aug;8(4):296-9. doi: 10.1016/s1058-2746(99)90148-9.
- Background: PubMed 19540777Yamamoto A, Takagishi K, Osawa T, Yanagawa T, Nakajima D, Shitara H, Kobayashi T. Prevalence and risk factors of a rotator cuff tear in the general population. J Shoulder Elbow Surg. 2010 Jan;19(1):116-20. doi: 10.1016/j.jse.2009.04.006.
- Background: PubMed 15047367Azzoni R, Cabitza P, Parrini M. Sonographic evaluation of subacromial space. Ultrasonics. 2004 Apr;42(1-9):683-7. doi: 10.1016/j.ultras.2003.11.015.
- Background: PubMed 16861541Saupe N, Pfirrmann CW, Schmid MR, Jost B, Werner CM, Zanetti M. Association between rotator cuff abnormalities and reduced acromiohumeral distance. AJR Am J Roentgenol. 2006 Aug;187(2):376-82. doi: 10.2214/AJR.05.0435.
- Background: PubMed 15249327Schmidt WA, Schmidt H, Schicke B, Gromnica-Ihle E. Standard reference values for musculoskeletal ultrasonography. Ann Rheum Dis. 2004 Aug;63(8):988-94. doi: 10.1136/ard.2003.015081.
- Background: PubMed 2703509Norwood LA, Barrack R, Jacobson KE. Clinical presentation of complete tears of the rotator cuff. J Bone Joint Surg Am. 1989 Apr;71(4):499-505.
- Background: PubMed 3771595Ellman H, Hanker G, Bayer M. Repair of the rotator cuff. End-result study of factors influencing reconstruction. J Bone Joint Surg Am. 1986 Oct;68(8):1136-44.
- Background: PubMed 28567226Kum DH, Kim JH, Park KM, Lee ES, Park YB, Yoo JC. Acromion Index in Korean Population and Its Relationship with Rotator Cuff Tears. Clin Orthop Surg. 2017 Jun;9(2):218-222. doi: 10.4055/cios.2017.9.2.218. Epub 2017 May 8.
- Background: PubMed 19451760Mayerhoefer ME, Breitenseher MJ, Wurnig C, Roposch A. Shoulder impingement: relationship of clinical symptoms and imaging criteria. Clin J Sport Med. 2009 Mar;19(2):83-9. doi: 10.1097/JSM.0b013e318198e2e3.
- Background: PubMed 18162412Werner CM, Conrad SJ, Meyer DC, Keller A, Hodler J, Gerber C. Intermethod agreement and interobserver correlation of radiologic acromiohumeral distance measurements. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):237-40. doi: 10.1016/j.jse.2007.06.002. Epub 2007 Dec 26.
- Background: PubMed 30368566Sasiponganan C, Dessouky R, Ashikyan O, Pezeshk P, McCrum C, Xi Y, Chhabra A. Subacromial impingement anatomy and its association with rotator cuff pathology in women: radiograph and MRI correlation, a retrospective evaluation. Skeletal Radiol. 2019 May;48(5):781-790. doi: 10.1007/s00256-018-3096-0. Epub 2018 Oct 27.
- 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.
Mehmet F Guven, Assoc.prof study director
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
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 and Rotator Cuff Tears, run by Göker Utku değer 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 1 inclusion and 4 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 31 Mar 2022. 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?
RELIABILITY OF DIRECT RADIOGRAPHY IMAGING (time frame: within 2 weeks after first evaluation). 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 NCT04759027, which also lists 19 linked publications.
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 31 Mar 2022.