Lumbar Spine Surgery Exceptations

Sponsor
Karabuk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05845060
Collaborator
(none)
175
1
5.9
29.6

Study Details

Study Description

Brief Summary

Low back pain is one of the most common reasons for applying to health institutions. Low back pain seriously affects the lives of patients and causes great financial losses. Surgical treatments have an important place in the treatment of pain due to lumbar spine pathologies. Although success in lumbar spine surgery 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 doctors to have the same priorities and meet the same realistic goals, it is necessary to understand what patients expect. Many studies have attempted to measure patients' expectations for lumbar spine treatment; however, most of them are unapproved, valid and unreliable scales. Lumbar spine surgery expectations scale was created by Mancuso et al. in 2013 to learn the expectations of patients in lumbar spine surgery. It has been found that the scale has high validity and reliability values and it has been observed that it is frequently used in clinics and researches. In our country, there is no valid and reliable scale that questions the expectations of patients from lumbar surgery. As a result of this study, it is planned to introduce a valid and reliable scale adapted into Turkish, which can question the expectations of patients from a lumbar surgery.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Low back pain is one of the most common reasons for applying to health institutions. Low back pain seriously affects the lives of patients and causes great financial losses. Surgical treatments have an important place in the treatment of pain due to lumbar spine pathologies. Although success in lumbar spine surgery 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 doctors to have the same priorities and meet the same realistic goals, it is necessary to understand what patients expect. Many studies have attempted to measure patients' expectations for lumbar spine treatment; however, most of them are unapproved, valid and unreliable scales. Lumbar spine surgery expectations scale was created by Mancuso et al. in 2013 to learn the expectations of patients in lumbar spine surgery. It has been found that the scale has high validity and reliability values and it has been observed that it is frequently used in clinics and researches. In our country, there is no valid and reliable scale that questions the expectations of patients from lumbar surgery. As a result of this study, it is planned to introduce a valid and reliable scale adapted into Turkish, which can question the expectations of patients from a lumbar surgery.

    Developing the scale in order to carry out the Turkish validity and reliability study of the Lumbar Spine Surgery Expectations scale and to confirm that the Turkish validity and reliability of the questionnaire was not done by another researcher, Prof. Dr. Mancuso Carol was contacted via e-mail and necessary permissions were obtained from him. The scale will be translated into Turkish by the study team after the approval of the ethical committee that there is no ethical objection to the conduct of the study. For this purpose, three researchers whose mother tongue is Turkish and fluent in English will separately translate the scale into Turkish, and then the final version of the scale will be obtained by three researchers. Physicians and physiotherapists working at KBU Training and Research Hospital will be asked to read the final version of the scale and evaluate the items in a way that is easy to understand and difficult to understand. Items that are stated to be difficult to understand will be reviewed. The scale items, whose intelligibility has been determined, will be translated into English by a translator whose native language is English and who is fluent in Turkish. The developer of the scale questionnaire translated into English, Prof. Dr. Mancuso will be sent to Carol and asked to evaluate whether there is consistency in meaning between the original scale and the translated scale. If the items are consistent, the Turkish version of the scale will be determined and it will be applied to patients who are planned for lumbar spine surgery. Together with the developed scale and Quebeck Waist Disability Scale, it will be applied to the patients by face-to-face method. In this way, the consistency of the developed scale with similar questionnaires that were previously reported to be valid will be examined. In order to determine the reliability of the scale, it will be applied again to the participants who agreed to fill in the questionnaire again one week later. The consistency of the scale will be determined by the data of the participants with the first and second scale scores.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    175 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Reliabılıty,Validity Of The Turkish Version Of The Lumbar Spine Surgery Exceptations
    Actual Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    May 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Lombar Spine Surgery Expectitaions [10 minutes]

      Lumbar spine surgery expectations scale was created by Mancuso et al. in 2013 to learn the expectations of patients in lumbar spine surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. 18 -65 years old

    2. To be able to read and write Turkish

    3. To have lumbar spine surgery planned by neurosurgery or orthopedist

    Exclusion Criteria:
    1. Being scheduled for revision surgery

    2. Having a cognitive deficit

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karabuk University Karabuk Center Turkey

    Sponsors and Collaborators

    • Karabuk University

    Investigators

    • Principal Investigator: Musa Gunes, MSC, Karabük University
    • Principal Investigator: Metehan Yana, Phd, Karabük University
    • Principal Investigator: Ismail Saracoglu, Phd, Kutahya Health Science University
    • Principal Investigator: Cihan Caner Aksoy, Phd, Kutahya Health Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Aydın Sinan Apaydin, Director, Karabuk University
    ClinicalTrials.gov Identifier:
    NCT05845060
    Other Study ID Numbers:
    • KarabukUniversity
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2023