AzTrials
AzTrials

Evaluating the Validity and Reliability of the Turkish WOOSNCT04373681

Validity and Reliability of the Turkish Version of WOOS

An observational study of Evaluating the Validity and Reliability of the Turkish WOOS, run by Gazi University at 3 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
patient-administered questionnaires
How many people
68 participants
Where
3 sitesTurkey (Türkiye)
Study dates
4 Dec 2017to 15 Mar 2020
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: Adult male and female patients with osteoarthritis of the shoulder

Who may be able to join

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

Who cannot join

  • Illiteracy, cognitive impairment, presence of shoulder circumference fractures

Trial locations and contacts

3 sites in 1 country.

Turkey (Türkiye)3 sites

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

    Ankara, 006560

  • Ankara Training and Research Hospital, Department of Orthopaedics & Traumatology

    Ankara, 06230

  • Gazi University Faculty of Health Sciences Physiotherapy and Rehabilitation Department

    Ankara, 06560

Other trials in Turkey (Türkiye)

About this study

Official title: Validity and Reliability of the Turkish Version of Western Ontario Osteoarthritis of the Shoulder Index

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.

Read the detailed description

Purpose; The aim of this study is to adapt the Western Ontario Osteoarthritis of the Shoulder Index (WOOS) specific to shoulder osteoarthritis, to Turkish and evaluate its validity and reliability.

Methods; WOOS index was translated and culturally adapted to Turkish, systematically. It was applied to 68 patients with osteoarthritis of the shoulder treated conservatively. The reliability of the scale was checked through internal consistency and test-retest methods. Internal consistency was analyzed with Cronbach's alpha value. Test-retest reliability was assessed using an intraclass correlation coefficient with 25 patients. The Western Ontario Rotator Cuff (WORC), The Shoulder Pain and Disability Index (SPADI), and The Society of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES) score were used to conduct concurrent validity.

Being tested
patient-administered questionnaires
Keywords
WOOS, validation, Osteoarthritis, Shoulder, Turkish, Version
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • patient-administered questionnairesOther

    patient-administered questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1st day

  2. 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

    Measured: 2 days later

  3. 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

    Measured: 1st day

  4. 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

    Measured: 1st day

  5. 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

    Measured: 1st day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2020
  2. Study start4 Dec 2017
  3. Primary completion10 Jan 2020
  4. Study completion15 Mar 2020

Resources

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
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04373681
Sponsor's protocol ID
Gazi Unv
Status last verified
Apr 2021
First submitted
27 Apr 2020
Last updated
19 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 6846007

  • 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.

    PubMed 30885102

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

    PubMed 18788237

  • 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.

    PubMed 11795997

  • 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.

    PubMed 21191606

  • 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.

    PubMed 22932692

  • 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.

    PubMed 32131050

  • 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.

    PubMed 26854052

  • 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

  • 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.

    PubMed 16799776

  • 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

  • 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.

    PubMed 22048932

  • 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.

    PubMed 15705040

  • 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.

    PubMed 22445627

  • 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.

    PubMed 24133377

Questions about this trial

What is this clinical trial studying?

An observational study of Evaluating the Validity and Reliability of the Turkish WOOS, run by Gazi University at 3 sites 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 1 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 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

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. (time frame: 1st day). The study lists 5 primary outcomes in all. 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 NCT04373681, which also lists 17 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 19 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in