NCT04547075

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

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

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

October 15, 2024

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

September 7, 2020

Last Update Submit

October 9, 2024

Conditions

Keywords

patient expectationslumbar spine surgeryturkish versionvalidity and reliability

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

1. Contact with developers and formation of steering committee 2. Translation from English to Turkish 3. Back translation from Turkish to English 4. Comparison of translation 5. Review of translated versions. 6. Reaching consensus and development of pilot version 7. Testing in clinical setting 8. Revision of pilot version 9. Testing of final version

Eligibility Criteria

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

Patients at Kutahya Health Sciences University Hospital will be interviewed in person with two questionnaires.

You may qualify if:

  • speak Turkish
  • arescheduled for lumbar spine surgery by one of two participating spine surgeons

You may not qualify if:

  • have cognitive deficits
  • refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal StenosisIntervertebral Disc DisplacementRadiculopathyFractures, BonePatient SatisfactionPatient Preference

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesWounds and InjuriesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ismail SARACOGLU, Ph.D.

    Kutahya Health Sciences University

    STUDY DIRECTOR
  • Cihan Cihan, Ph.D.

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR
  • Metehan YANA, Ph.D.

    Karabuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 14, 2020

Study Start

February 15, 2021

Primary Completion

January 15, 2023

Study Completion

February 15, 2023

Last Updated

October 15, 2024

Record last verified: 2023-03

Locations