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Low Back PainNCT05845060

Lumbar Spine Surgery Exceptations

An observational study of Low Back Pain, run by Karabuk University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Low Back Pain
How many people
175 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2023to 30 Jun 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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The sample of this study will consist of volunteer patients who applied to the Neurosurgery outpatient clinic of Karabuk University Training and Research Hospital and who were at the surgical level due to chronic low back pain.

Who may be able to join

  • 18 -65 years old
  • To be able to read and write Turkish
  • To have lumbar spine surgery planned by neurosurgery or orthopedist

Who cannot join

  • Being scheduled for revision surgery
  • Having a cognitive deficit

Trial locations and contacts

1 site in 1 country.

Aydin Sinan Apaydin, MD contact

+905065897613

dr.sinanapaydin@yahoo.com

Aydin Sinan Apaydin, MD contact

+905065897613

Turkey (Türkiye)1 site, 1 recruiting
  • Karabuk University

    Karabük, Center

    Aydin Sinan Apaydin, MD, +905065897613, dr.sinanapaydin@yahoo.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Reliabılıty,Validity Of The Turkish Version Of The Lumbar Spine Surgery Exceptations

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.

Read the 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.

Conditions
Low Back Pain
Medical subject headings
Low Back Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lombar Spine Surgery Expectitaions

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

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start1 Jan 2023
  3. Primary completion30 May 2023 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

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
175 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05845060
Sponsor's protocol ID
KarabukUniversity
Status last verified
Apr 2023
First submitted
25 Apr 2023
Last updated
6 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 1. Mancuso, C. A., Cammisa, F. P., Sama, A. A., Hughes, A. P., Ghomrawi, H. M., & Girardi, F. P. (2013). Development and testing of an expectations survey for patients undergoing lumbar spine surgery. JBJS, 95(19), 1793-1800. 2. Aoude, A., Litowski, M., Aldebeyan, S., Fisher, C., Hall, H., Manson, N., ... & Paquet, J. (2020). A Comparison of Patient and Surgeon Expectations of Spine Surgical Outcomes. Global Spine Journal, 2192568220907603. 3. Nepomuceno, E., Silveira, R. C. D. C. P., Dessotte, C. A. M., Furuya, R. K., Arantes, E. D. C., Cunha, D. C. P. T. D., & Dantas, R. A. S. (2016). Instruments used in the assessment of expectation toward a spine surgery: an integrative review. Revista da Escola de Enfermagem da USP, 50(4), 658-666.

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by Karabuk 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 3 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Aydin Sinan Apaydin, MD (+905065897613, dr.sinanapaydin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lombar Spine Surgery Expectitaions (time frame: 10 minutes). 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 NCT05845060, which also lists 1 linked publication.

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 6 May 2023.

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