Reliability of the Subacromial Distance Measurements With Standard Radiographic Imaging
Prospective Evaluation of the Reliability and Re-applicability of Subacromial Distance Measurement With Standard Radiographic Imaging Compared to Ultrasound Imaging
1 other identifier
observational
56
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2021
CompletedFirst Posted
Study publicly available on registry
February 17, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMarch 31, 2022
March 1, 2022
8 months
February 1, 2021
March 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
within 2 weeks after first evaluation
Secondary Outcomes (1)
REPRODUCIBLITY
1 month apart measurements will be evaluate
Study Arms (2)
X-ray
Measurements of subacromial distance on standardized direct radiography
ultrasound
Measurements of subacromial distance on ultrasound
Interventions
Eligibility Criteria
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.
You may qualify if:
- shoulder pain ( acute traumatic or non-traumatic chronic)
You may not qualify if:
- end stage glenohumeral joint arthrosis
- adhesive capsulitis
- fractures
- previous shoulder surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Göker Utku değerlead
Study Sites (1)
Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Related Publications (19)
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.
PMID: 15163107BACKGROUNDTempelhof 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.
PMID: 10471998BACKGROUNDYamamoto 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.
PMID: 19540777BACKGROUNDAzzoni 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.
PMID: 15047367BACKGROUNDSaupe 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.
PMID: 16861541BACKGROUNDSchmidt 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.
PMID: 15249327BACKGROUNDNorwood 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.
PMID: 2703509BACKGROUNDEllman 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.
PMID: 3771595BACKGROUNDKum 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.
PMID: 28567226BACKGROUNDMayerhoefer 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.
PMID: 19451760BACKGROUNDWerner 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.
PMID: 18162412BACKGROUNDSasiponganan 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.
PMID: 30368566BACKGROUNDYoshida 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.
PMID: 32967710BACKGROUNDvan 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.
PMID: 16462449BACKGROUNDUeda 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.
PMID: 32471753BACKGROUNDXu M, Li Z, Zhou Y, Ji B, Tian S, Chen G. Correlation between acromiohumeral distance and the severity of supraspinatus tendon tear by ultrasound imaging in a Chinese population. BMC Musculoskelet Disord. 2020 Feb 17;21(1):106. doi: 10.1186/s12891-020-3109-8.
PMID: 32066419BACKGROUNDPijls BG, Kok FP, Penning LI, Guldemond NA, Arens HJ. Reliability study of the sonographic measurement of the acromiohumeral distance in symptomatic patients. J Clin Ultrasound. 2010 Mar-Apr;38(3):128-34. doi: 10.1002/jcu.20674.
PMID: 20127966BACKGROUNDMcCreesh KM, Crotty JM, Lewis JS. Acromiohumeral distance measurement in rotator cuff tendinopathy: is there a reliable, clinically applicable method? A systematic review. Br J Sports Med. 2015 Mar;49(5):298-305. doi: 10.1136/bjsports-2012-092063. Epub 2013 Jul 2.
PMID: 25690908BACKGROUNDFehringer EV, Rosipal CE, Rhodes DA, Lauder AJ, Puumala SE, Feschuk CA, Mormino MA, Hartigan DE. The radiographic acromiohumeral interval is affected by arm and radiographic beam position. Skeletal Radiol. 2008 Jun;37(6):535-9. doi: 10.1007/s00256-008-0467-y.
PMID: 18343920BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mehmet F Guven, Assoc.prof
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research assistant
Study Record Dates
First Submitted
February 1, 2021
First Posted
February 17, 2021
Study Start
May 1, 2021
Primary Completion
December 31, 2021
Study Completion
March 1, 2022
Last Updated
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share