Shoulder PainNCT04954053
The Turkish Version of the WUSPI
An observational study of Shoulder Pain, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Wheelchair users frequently experience shoulder pain. It has been determined that in our country, the subjective assessment methods that will help to determine and monitor shoulder pain severity of wheelchair users are limited. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2017to 13 Jul 2017
- How long will I take part?
- 2 Weeks
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult wheelchair users who used manual wheelchairs as the primary mobility tool for more than a year
Who may be able to join
- accepting the participation
- using manual wheelchairs as the primary mobility tool for more than a year
Who cannot join
- being illiterate,
- having cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences Physioteraphy and Rehabilitation Department
Ankara, Çankaya, 06300
About this study
Official title: Validity and Reliability of the Turkish Version of Wheelchair User's Shoulder Pain Index
Wheelchair users frequently experience shoulder pain. It has been determined that in our country, the subjective assessment methods that will help to determine and monitor shoulder pain severity of wheelchair users are limited. The purpose of this study is to adapt the original English version of the Wheelchair Users Shoulder Pain Index into Turkish and to assess its validity and reliability.
Firstly, the original English version of WUSPI was translated into Turkish and culturally adapted, then applied to 100 wheelchair users to investigate the validity of the scale. The reliability of the scale was assessed by internal consistency and test-retest analysis and found a high internal consistency. Validation of WUSPI-Tr was assessed by the concurrent validity method. To establish concurrent validity, WUSPI scores were compared to SPADI and ASES scores by Spearman correlation analysis. There was a positively excellent correlation with SPADI and, negatively excellent correlation with ASES. As a result, it is determined tath the Turkish version of WUSPI-Tr is a valid and reliable tool.
Read the detailed description
The original version of WUSPI was translated into Turkish via multistep translation rules. It is culturally adapted into Turkish. The semantic equivalence of the new scale was evaluated and the Turkish version of the WUSPI (WUSPI-Tr) has been created. It is applied to 100 wheelchair users to investigate the validity of the scale. People who are at least for 1 year using a manual wheelchair as their primary means of mobility, cognitively unimpaired, literate, and older than 18 years are included in this study. The reliability of the scale was assessed by internal consistency and test-retest analysis. As a result of the analysis, the Cronbach Alfa value was calculated as 0.894, and WUSPI-Tr was found to have high internal consistency. The WUSPI-Tr questionnaire was re-administered to 50 participants for 7 to 14 days for the test-retest method and the results were compared with the Interclass Correlation Coefficient (ICC) method. WUSPI has been found to have high reliability (0.997). Validation of WUSPI-Tr was assessed by the concurrent validity method. To establish concurrent validity, WUSPI scores were compared to SPADI and ASES scores by Spearman correlation analysis. The correlation coefficient of WUSPI-Tr with SPADI is 0.931 and with ASES was -0.812. These results show that there was a positively excellent correlation with SPADI and, negatively excellent correlation with ASES (p < 0,001). As a result, the Turkish version of WUSPI-Tr is a valid and reliable tool.
- Conditions
- Shoulder Pain
- Keywords
- Wheelchair User, WUSPI, Turkish version, Validity and Reliability
- Medical subject headings
- Shoulder Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheelchair User's Shoulder Pain Index
self-reported outcome measure
Measured: First Day
Shoulder Pain and Disability Index (SPADI)
self-reported outcome measure
Measured: First Day
The Society of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
self-reported outcome measure
Measured: First Day
Wheelchair User's Shoulder Pain Index
self-reported outcome measure
Measured: 2 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start5 Feb 2017
- Primary completion26 Apr 2017
- Study completion13 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- 100 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyda ÖZAL, Gazi University
- Investigators
- Şeyda ÖZAL, MSc, Principal investigator, Gazi University Faculty of Health Sciences Physiotherapy and Rehabilitation DepartmentSelda Başar, Assoc Prof, Study director, Gazi University Faculty of Health Sciences Physiotherapy and Rehabilitation DepartmentNevin Ergun, Prof Dr, Study chair, Sanko University Faculty of Health Sciences Physiotherapy and Rehabilitation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954053
- Sponsor's protocol ID
- Gazi Uni
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Publications
Gellman H, Sie I, Waters RL. Late complications of the weight-bearing upper extremity in the paraplegic patient. Clin Orthop Relat Res. 1988 Aug;(233):132-5.
PubMed 3402118Curtis KA, Black K. Shoulder pain in female wheelchair basketball players. J Orthop Sports Phys Ther. 1999 Apr;29(4):225-31. doi: 10.2519/jospt.1999.29.4.225.
PubMed 10322595Finley MA, Rodgers MM. Prevalence and identification of shoulder pathology in athletic and nonathletic wheelchair users with shoulder pain: A pilot study. J Rehabil Res Dev. 2004 May;41(3B):395-402. doi: 10.1682/jrrd.2003.02.0022.
PubMed 15543457Curtis KA, Roach KE, Applegate EB, Amar T, Benbow CS, Genecco TD, Gualano J. Development of the Wheelchair User's Shoulder Pain Index (WUSPI). Paraplegia. 1995 May;33(5):290-3. doi: 10.1038/sc.1995.65.
PubMed 7630657Curtis KA, Roach KE, Applegate EB, Amar T, Benbow CS, Genecco TD, Gualano J. Reliability and validity of the Wheelchair User's Shoulder Pain Index (WUSPI). Paraplegia. 1995 Oct;33(10):595-601. doi: 10.1038/sc.1995.126.
PubMed 8848314Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735Snyder 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 22048932Weir 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of Wheelchair User's Shoulder Pain Index
- ClinicalTrials.gov ID
- NCT04954053
- Acronym / sponsor ID
- Gazi Uni
- Conditions
- Shoulder Pain
- Keywords
- Wheelchair User, WUSPI, Turkish version, Validity and Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 5 Feb 2017 (actual)
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 8 Jul 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.
Wheelchair users frequently experience shoulder pain. It has been determined that in our country, the subjective assessment methods that will help to determine and monitor shoulder pain severity of wheelchair users are limited. The purpose of this study is to adapt the original English version of the Wheelchair Users Shoulder Pain Index into Turkish and to assess its validity and reliability.
Firstly, the original English version of WUSPI was translated into Turkish and culturally adapted, then applied to 100 wheelchair users to investigate the validity of the scale. The reliability of the scale was assessed by internal consistency and test-retest analysis and found a high internal consistency. Validation of WUSPI-Tr was assessed by the concurrent validity method. To establish concurrent validity, WUSPI scores were compared to SPADI and ASES scores by Spearman correlation analysis. There was a positively excellent correlation with SPADI and, negatively excellent correlation with ASES. As a result, it is determined tath the Turkish version of WUSPI-Tr is a valid and reliable tool.
Detailed description
The original version of WUSPI was translated into Turkish via multistep translation rules. It is culturally adapted into Turkish. The semantic equivalence of the new scale was evaluated and the Turkish version of the WUSPI (WUSPI-Tr) has been created. It is applied to 100 wheelchair users to investigate the validity of the scale. People who are at least for 1 year using a manual wheelchair as their primary means of mobility, cognitively unimpaired, literate, and older than 18 years are included in this study. The reliability of the scale was assessed by internal consistency and test-retest analysis. As a result of the analysis, the Cronbach Alfa value was calculated as 0.894, and WUSPI-Tr was found to have high internal consistency. The WUSPI-Tr questionnaire was re-administered to 50 participants for 7 to 14 days for the test-retest method and the results were compared with the Interclass Correlation Coefficient (ICC) method. WUSPI has been found to have high reliability (0.997). Validation of WUSPI-Tr was assessed by the concurrent validity method. To establish concurrent validity, WUSPI scores were compared to SPADI and ASES scores by Spearman correlation analysis. The correlation coefficient of WUSPI-Tr with SPADI is 0.931 and with ASES was -0.812. These results show that there was a positively excellent correlation with SPADI and, negatively excellent correlation with ASES (p < 0,001). As a result, the Turkish version of WUSPI-Tr is a valid and reliable tool.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult wheelchair users who used manual wheelchairs as the primary mobility tool for more than a year
Key inclusion criteria (2 listed)
- accepting the participation
- using manual wheelchairs as the primary mobility tool for more than a year
Key exclusion criteria (2 listed)
- being illiterate,
- having cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wheelchair User's Shoulder Pain Index
Time frame: First Day
self-reported outcome measure
Shoulder Pain and Disability Index (SPADI)
Time frame: First Day
self-reported outcome measure
The Society of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Time frame: First Day
self-reported outcome measure
Wheelchair User's Shoulder Pain Index
Time frame: 2 weeks later
self-reported outcome measure
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 8 Jul 2021.
- Background: PubMed 3402118Gellman H, Sie I, Waters RL. Late complications of the weight-bearing upper extremity in the paraplegic patient. Clin Orthop Relat Res. 1988 Aug;(233):132-5.
- Background: PubMed 10322595Curtis KA, Black K. Shoulder pain in female wheelchair basketball players. J Orthop Sports Phys Ther. 1999 Apr;29(4):225-31. doi: 10.2519/jospt.1999.29.4.225.
- Background: PubMed 15543457Finley MA, Rodgers MM. Prevalence and identification of shoulder pathology in athletic and nonathletic wheelchair users with shoulder pain: A pilot study. J Rehabil Res Dev. 2004 May;41(3B):395-402. doi: 10.1682/jrrd.2003.02.0022.
- Background: PubMed 7630657Curtis KA, Roach KE, Applegate EB, Amar T, Benbow CS, Genecco TD, Gualano J. Development of the Wheelchair User's Shoulder Pain Index (WUSPI). Paraplegia. 1995 May;33(5):290-3. doi: 10.1038/sc.1995.65.
- Background: PubMed 8848314Curtis KA, Roach KE, Applegate EB, Amar T, Benbow CS, Genecco TD, Gualano J. Reliability and validity of the Wheelchair User's Shoulder Pain Index (WUSPI). Paraplegia. 1995 Oct;33(10):595-601. doi: 10.1038/sc.1995.126.
- Background: PubMed 11124735Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
- Background: PubMed 22048932Snyder 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.
- Background: PubMed 15705040Weir 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.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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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.
Şeyda ÖZAL, MSc principal investigator
Gazi University Faculty of Health Sciences Physiotherapy and Rehabilitation Department
Selda Başar, Assoc Prof study director
Gazi University Faculty of Health Sciences Physiotherapy and Rehabilitation Department
Nevin Ergun, Prof Dr study chair
Sanko University Faculty of Health Sciences Physiotherapy and Rehabilitation Department
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 Shoulder Pain, run by Gazi University 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 2 inclusion and 2 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 8 Jul 2021. 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?
Wheelchair User's Shoulder Pain Index (time frame: First Day). The study lists 4 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 NCT04954053, which also lists 8 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 8 Jul 2021.