NCT04373681

Brief Summary

Various clinical scales are available to investigate shoulder diseases. Some of them, culturally adapted to the Turkish population. However, none of them are specific for osteoarthritis of the shoulder. Thus, this study aimed to translate the WOOS index into Turkish and investigate its psychometric properties in the Turkish population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

December 4, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

2.1 years

First QC Date

April 27, 2020

Last Update Submit

April 15, 2021

Conditions

Keywords

WOOSvalidationOsteoarthritisShoulderTurkishVersion

Outcome Measures

Primary Outcomes (5)

  • Western Ontario Osteoarthritis of the Shoulder Index, patients get a minimum of 0 points (best condition) and a maximum of 1900 points (worst condition) on this scale.

    patient administered, spesific to osteoarthritis of shoulder, multisectional questionnaire

    1st day

  • Western Ontario Osteoarthritis of the Shoulder Index, patients get a minimum of 0 points (best condition) and a maximum of 1900 points (worst condition) on this scale.

    patient administered, spesific to osteoarthritis of shoulder, multisectional questionnaire

    2 days later

  • The Western Ontario Rotator Cuff Index, patients get a minimum of 0 points (best condition) and a maximum of 2100 points (worst condition) on this scale.

    patient administered, spesific to rotator cuff disease, multisectional questionnaire

    1st day

  • The Shoulder Pain and Disability Index, patients get a minimum of 0 points (best condition) and a maximum of 100 points (worst condition) on this scale.

    patient administered, spesific to upper limp, two sectional questionnaire

    1st day

  • The Society of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment, patients get a minimum of 0 points (worst condition) and a maximum of 100 points (best condition) on this scale.

    patient administered, spesific to upper limp, two sectional questionnaire

    1st day

Interventions

patient-administered questionnaires

Eligibility Criteria

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

Adult male and female patients with osteoarthritis of the shoulder

You may qualify if:

  • Presence of the shoulder osteoarthritis, to be a native Turkish speaker

You may not qualify if:

  • Illiteracy, cognitive impairment, presence of shoulder circumference fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dr. Sami Ulus Maternity, Child Health and Diseases Training and Research Hospital, Department of Orthopaedics & Traumatology

Ankara, 006560, Turkey (Türkiye)

Location

Ankara Training and Research Hospital, Department of Orthopaedics & Traumatology

Ankara, 06230, Turkey (Türkiye)

Location

Gazi University Faculty of Health Sciences Physiotherapy and Rehabilitation Department

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (17)

  • Petersson CJ. Degeneration of the gleno-humeral joint. An anatomical study. Acta Orthop Scand. 1983 Apr;54(2):277-83. doi: 10.3109/17453678308996570.

    PMID: 6846007BACKGROUND
  • Ozer M, Ataoglu MB, Cetinkaya M, Ayanoglu T, Kaptan AY, Kanatli U. Do intra-articular pathologies accompanying symptomatic acromioclavicular joint degeneration vary across age groups? Eklem Hastalik Cerrahisi. 2019 Apr;30(1):2-9. doi: 10.5606/ehc.2019.62431.

    PMID: 30885102BACKGROUND
  • Millett PJ, Gobezie R, Boykin RE. Shoulder osteoarthritis: diagnosis and management. Am Fam Physician. 2008 Sep 1;78(5):605-11.

    PMID: 18788237BACKGROUND
  • Lo IK, Griffin S, Kirkley A. The development of a disease-specific quality of life measurement tool for osteoarthritis of the shoulder: The Western Ontario Osteoarthritis of the Shoulder (WOOS) index. Osteoarthritis Cartilage. 2001 Nov;9(8):771-8. doi: 10.1053/joca.2001.0474.

    PMID: 11795997BACKGROUND
  • Tugay U, Tugay N, Gelecek N, Ozkan M. Oxford Shoulder Score: cross-cultural adaptation and validation of the Turkish version. Arch Orthop Trauma Surg. 2011 May;131(5):687-94. doi: 10.1007/s00402-010-1242-9. Epub 2010 Dec 30.

    PMID: 21191606BACKGROUND
  • Celik D, Atalar AC, Demirhan M, Dirican A. Translation, cultural adaptation, validity and reliability of the Turkish ASES questionnaire. Knee Surg Sports Traumatol Arthrosc. 2013 Sep;21(9):2184-9. doi: 10.1007/s00167-012-2183-3. Epub 2012 Aug 30.

    PMID: 22932692BACKGROUND
  • Najafov E, Ozal S, Kaptan AY, Ulucakoy C, Kanatli U, Ataoglu B, Basar S. Validity and Reliability of the Turkish Version of LHB Score. J Sport Rehabil. 2020 Mar 4;30(1):30-36. doi: 10.1123/jsr.2019-0364.

    PMID: 32131050BACKGROUND
  • Celik D. Turkish version of the modified Constant-Murley score and standardized test protocol: reliability and validity. Acta Orthop Traumatol Turc. 2016;50(1):69-75. doi: 10.3944/AOTT.2016.14.0354.

    PMID: 26854052BACKGROUND
  • Beaton D, Bombardier C, Guillemin F, Ferraz MB (2002) Recommendations for the cross-cultural adaptation of health status measures. New York: American Academy of Orthopaedic Surgeons 12:1-9

    BACKGROUND
  • El O, Bircan C, Gulbahar S, Demiral Y, Sahin E, Baydar M, Kizil R, Griffin S, Akalin E. The reliability and validity of the Turkish version of the Western Ontario Rotator Cuff Index. Rheumatol Int. 2006 Oct;26(12):1101-8. doi: 10.1007/s00296-006-0151-2. Epub 2006 Jun 24.

    PMID: 16799776BACKGROUND
  • Bumin G, Tüzün EH, Tonga E (2008) The Shoulder Pain and Disability Index (SPADI): Cross-cultural adaptation, reliability, and validity of the Turkish version. Journal of Back and Musculoskeletal Rehabilitation 21(1):57-62

    BACKGROUND
  • Snyder CF, Aaronson NK, Choucair AK, Elliott TE, Greenhalgh J, Halyard MY, Hess R, Miller DM, Reeve BB, Santana M. Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations. Qual Life Res. 2012 Oct;21(8):1305-14. doi: 10.1007/s11136-011-0054-x. Epub 2011 Nov 3.

    PMID: 22048932BACKGROUND
  • Weir JP. Quantifying test-retest reliability using the intraclass correlation coefficient and the SEM. J Strength Cond Res. 2005 Feb;19(1):231-40. doi: 10.1519/15184.1.

    PMID: 15705040BACKGROUND
  • Klintberg IH, Lind K, Marlow T, Svantesson U. Western Ontario Osteoarthritis Shoulder (WOOS) index: a cross-cultural adaptation into Swedish, including evaluation of reliability, validity, and responsiveness in patients with subacromial pain. J Shoulder Elbow Surg. 2012 Dec;21(12):1698-705. doi: 10.1016/j.jse.2011.11.027. Epub 2012 Mar 21.

    PMID: 22445627BACKGROUND
  • Rasmussen JV, Jakobsen J, Olsen BS, Brorson S. Translation and validation of the Western Ontario Osteoarthritis of the Shoulder (WOOS) index - the Danish version. Patient Relat Outcome Meas. 2013 Sep 18;4:49-54. doi: 10.2147/PROM.S50976. eCollection 2013.

    PMID: 24133377BACKGROUND
  • Corona K, Cerciello S, Morris BJ, Visona E, Merolla G, Porcellini G. Cross-cultural adaptation and validation of the Italian version of the Western Ontario Osteoarthritis of the Shoulder index (WOOS). J Orthop Traumatol. 2016 Dec;17(4):309-313. doi: 10.1007/s10195-016-0400-4. Epub 2016 Mar 31.

    PMID: 27033229BACKGROUND
  • Jia ZY, Zhang C, Cui J, Xue CC, Xu WD. Translation and validation of the Simplified Chinese version of Western Ontario Osteoarthritis of the Shoulder Index (WOOS). Medicine (Baltimore). 2018 Mar;97(13):e8691. doi: 10.1097/MD.0000000000008691.

    PMID: 29595694BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Nevin A GÜZEL, Prof

    Gazi University Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Şeyda ÖZAL, MSc

    Gazi University Faculty of Health Sciences

    STUDY CHAIR
  • Ahmet Y KAPTAN, MD

    Dr. Sami Ulus Hospital

    STUDY CHAIR
  • Nihan KAFA, Assc Prof

    Gazi University Faculty of Health Sciences

    STUDY CHAIR
  • Toygun K EREN, MD

    Ankara Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asistant

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 4, 2020

Study Start

December 4, 2017

Primary Completion

January 10, 2020

Study Completion

March 15, 2020

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations