NCT04759027

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

February 1, 2021

Last Update Submit

March 30, 2022

Conditions

Keywords

x-raydirect radiographyultrasoundacromiohumeral distancesubacromial distancerotator cuff

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

Other: subacromial distance measurement

ultrasound

Measurements of subacromial distance on ultrasound

Other: subacromial distance measurement

Interventions

distance between acromion and humerus

X-rayultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

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

Study Sites (1)

Istanbul University- Cerrahpasa Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

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: 15163107BACKGROUND
  • Tempelhof 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: 10471998BACKGROUND
  • Yamamoto 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: 19540777BACKGROUND
  • Azzoni 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: 15047367BACKGROUND
  • Saupe 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: 16861541BACKGROUND
  • Schmidt 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: 15249327BACKGROUND
  • Norwood 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: 2703509BACKGROUND
  • Ellman 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: 3771595BACKGROUND
  • Kum 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: 28567226BACKGROUND
  • Mayerhoefer 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: 19451760BACKGROUND
  • Werner 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: 18162412BACKGROUND
  • Sasiponganan 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: 30368566BACKGROUND
  • Yoshida 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: 32967710BACKGROUND
  • van 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: 16462449BACKGROUND
  • Ueda 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: 32471753BACKGROUND
  • Xu 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: 32066419BACKGROUND
  • Pijls 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: 20127966BACKGROUND
  • McCreesh 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: 25690908BACKGROUND
  • Fehringer 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

Shoulder Impingement SyndromeRotator Cuff Injuries

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesRuptureTendon Injuries

Study Officials

  • Mehmet F Guven, Assoc.prof

    Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

    STUDY DIRECTOR

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

Locations