Lumbar Spinal StenosisNCT04547075
In Turkish Version Lumbar Spine Surgery Expectation Survey
An observational study of Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the Turkish validity and reliability of Lumbar Spine Surgery Expectations Survey developed by Mancuso. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Radiculopathy
- What is being tested?
- Turkish validity and reliability
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to 15 Feb 2023
- 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: Patients at Kutahya Health Sciences University Hospital will be interviewed in person with two questionnaires.
Who may be able to join
- speak Turkish
- arescheduled for lumbar spine surgery by one of two participating spine surgeons
Who cannot join
- have cognitive deficits
- refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Validity and Reliability of Lumbar Spine Surgery Expectation Survey
The aim of this study was to determine the Turkish validity and reliability of Lumbar Spine Surgery Expectations Survey developed by Mancuso.
Read the detailed 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.
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Radiculopathy, Lumbar Fracture, Patient Satisfaction, Patient Preference
- Being tested
- Turkish validity and reliability
- Keywords
- patient expectations, lumbar spine surgery, turkish version, validity and reliability
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Displacement, Radiculopathy, Fractures, Bone, Patient Satisfaction, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish validity and reliabilityOther
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start15 Feb 2021
- Primary completion15 Jan 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Saracoglu, Kutahya Health Sciences University
- Investigators
- Ismail SARACOGLU, Ph.D., Study director, Kutahya Health Sciences UniversityCihan Cihan, Ph.D., Principal investigator, Kutahya Health Sciences UniversityMetehan YANA, Ph.D., Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547075
- Sponsor's protocol ID
- KutahyaMSUspinesurgery
- Status last verified
- Mar 2023
- First submitted
- 7 Sep 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of Lumbar Spine Surgery Expectation Survey
- ClinicalTrials.gov ID
- NCT04547075
- Acronym / sponsor ID
- KutahyaMSUspinesurgery
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Radiculopathy, Lumbar Fracture, Patient Satisfaction, Patient Preference
- Keywords
- patient expectations, lumbar spine surgery, turkish version, validity and reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 14 Sep 2020 (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.
The aim of this study was to determine the Turkish validity and reliability of Lumbar Spine Surgery Expectations Survey developed by Mancuso.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Kutahya Health Sciences University Hospital will be interviewed in person with two questionnaires.
Key inclusion criteria (2 listed)
- speak Turkish
- arescheduled for lumbar spine surgery by one of two participating spine surgeons
Key exclusion criteria (2 listed)
- have cognitive deficits
- refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish validity and reliability1. 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 | Other | – |
Primary outcome
Lumbar Spine Surgery Expectation Survey
Time frame: 10 minutes
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).
Quebeck Back Pain Disability Index
Time frame: 10 minutes
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.
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 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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LUMBAR STENOSIS
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.
Ismail SARACOGLU, Ph.D. study director
Kutahya Health Sciences University
Cihan Cihan, Ph.D. principal investigator
Kutahya Health Sciences University
Metehan YANA, Ph.D. principal investigator
Karabuk University
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 Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by Kutahya Health Sciences 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 15 Oct 2024. 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?
Lumbar Spine Surgery Expectation Survey (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.