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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04547075
Other study ID # KutahyaMSUspinesurgery
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2021
Est. completion date February 15, 2023

Study information

Verified date March 2023
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study was to determine the Turkish validity and reliability of Lumbar Spine Surgery Expectations Survey developed by Mancuso.


Description:

Although success in lumbar spine surgeries depends on many factors, it has been reported that one of the most important of these factors is patient expectations. In order for patients and health professionals to have the same priorities and meet the same realistic goals, it is necessary to understand what patients expect. Lumbar spine surgery expectations scale was created by Mancuso et al. The aim of this study was to determine the Turkish validity and reliability of Lumbar Spine Surgery Expectations Survey developed by Mancuso.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date February 15, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - speak Turkish - arescheduled for lumbar spine surgery by one of two participating spine surgeons Exclusion Criteria: - have cognitive deficits - refuse to participate

Study Design


Intervention

Other:
Turkish validity and reliability
Contact with developers and formation of steering committee Translation from English to Turkish Back translation from Turkish to English Comparison of translation Review of translated versions. Reaching consensus and development of pilot version Testing in clinical setting Revision of pilot version Testing of final version

Locations

Country Name City State
Turkey Kutahya Health Sciences University Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lumbar Spine Surgery Expectation Survey The Survey has been described in detail previously with respect to validity, reliability, and factor analysis. The Survey addresses pain, function, work status, mental well-being, and anticipated future spine condition.It is prefaced by the question ''How much relief or improvement do you expect in the following areas as a result of the treatment for your spine?'' Response options are ''back to normal or complete improvement'' (4 points), ''not back to normal but a lot of improvement'' (3 points), ''a moderate amount of improvement'' (2 points), ''a little improvement'' (1 point), and ''I do not have this expectation or this expectation does not apply to me'' (0 points). 10 minutes
Primary Quebeck Back Pain Disability Index The Quebeck Back Pain Disability Index is a condition-specific measure of disability that was described by Kopec et al. The scale contains 20 daily activities and asks the patient to rate his or her degree of difficulty in performing each activity from 0 ("not difficult at all") to 5 ("unable to do"). The item scores were summed for a total score between 0 and 100, with higher numbers representing greater levels of disability. 10 minutes
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