NCT05845060

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

April 25, 2023

Last Update Submit

April 25, 2023

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (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.

    10 minutes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

  • Being scheduled for revision surgery
  • Having a cognitive deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, Center, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aydin Sinan Apaydin, MD

CONTACT

+905065897613dr.sinanapaydin@yahoo.com

Aydin Sinan Apaydin, MD

CONTACT

+905065897613

Study Design

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

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 6, 2023

Study Start

January 1, 2023

Primary Completion

May 30, 2023

Study Completion

June 30, 2023

Last Updated

May 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)