- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02257554
Comparing Patients' and Surgeons' Expectations of Lumbar Spine Surgery
February 11, 2026 updated by: Hospital for Special Surgery, New York
The goals of this study are to assess concordance between the patient-surgeon pair regarding expectations of lumbar spine surgery.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Low back pain is a prevalent medical condition afflicting primarily older adults but affecting all age groups and due to acute and non-acute diagnoses.
Multiple possible conservative therapies exist; however, their major drawback is that the time required to advance therapy is often prolonged and accompanied by persistent disability and psychological suffering.
Thus, some patients seek surgery after exhausting other therapies and some patients seek surgery earlier in their course.
For both groups, decisions to undergo surgery are based on personal circumstances, perspectives, and expectations of outcome.
Prior studies have shown that patients typically have high expectations of orthopedic surgery.
Although high aspirations can be motivating, they also may predispose to poor outcomes if they are unrealistic and cause patients to become discouraged with recuperation time and ignore recommended lifestyle changes that avert progression of disease.
Expectations that are too low, conversely, also may predispose to poor outcomes if patients lack motivation to participate in rehabilitation and to follow postop precautions.
In order to achieve maximum benefit from surgery, patients and surgeons need to share an understanding of what is possible, probable, and realistic, and to join together and work toward the same goals.
The primary objective of this proposed cross-sectional study is to assess the concordance between patients and their surgeons regarding expectations of lumbar spine surgery.
Patients scheduled for lumbar surgery will be dichotomized according to whether they have acute versus non-acute conditions.
Several days before surgery patients will complete the validated Lumbar Spine Surgery Expectations Survey measuring their physical and psychological expectations.
Also before surgery their surgeons will complete the surgeon's version of the same survey for each patient.
The main outcome will be a comparison of the concordance within each patient-surgeon pair according to acute versus non-acute groups based on the concordance correlation coefficient.
Multivariate regression analysis based on the GEE method will be used to assess covariates.
Study Type
Observational
Enrollment (Actual)
437
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
-
New York, New York, United States, 10021
- Hospital for Special Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for lumbar spine surgery and their surgeons
Description
Inclusion Criteria:
- Patients will be eligible if they are ≥ 18 years old, speak English, and are scheduled for non-trauma-related lumbar spine surgery.
Exclusion Criteria:
- Patients will be excluded if they have cognitive deficits and cannot provide informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of Lumbar Spine Surgery Expectations Survey scores for patients and their surgeons.
Time Frame: participants will be surveyed before surgery, an expected average of 5 days
|
comparison of patients and surgeons responses
|
participants will be surveyed before surgery, an expected average of 5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carol A Mancuso, MD, Hospital for Special Surgery, New York
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
September 30, 2014
First Submitted That Met QC Criteria
October 3, 2014
First Posted (Estimated)
October 6, 2014
Study Record Updates
Last Update Posted (Actual)
February 13, 2026
Last Update Submitted That Met QC Criteria
February 11, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-287
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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