Comparing Patients' and Surgeons' Expectations of Lumbar Spine Surgery

Lumbar Spine Surgery Clinical Trial

Official title:

Comparing Patients' and Surgeons' Expectations of Lumbar Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02257554
• Other study ID #: 2014-287
• Status: Recruiting
• Start date: September 2014
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Hospital for Special Surgery, New York
• Contact: Carol A Mancuso, MD
• Phone: 212-774-7508
• Email: mancusoc[@]hss.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goals of this study are to assess concordance between the patient-surgeon pair regarding expectations of lumbar spine surgery.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Spine Surgery

Intervention

Behavioral:
• education
Discussion of surgical expectations with patients

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mancuso CA, Cammisa FP, Sama AA, Hughes AP, Ghomrawi HM, Girardi FP. Development and testing of an expectations survey for patients undergoing lumbar spine surgery. J Bone Joint Surg Am. 2013 Oct 2;95(19):1793-800. doi: 10.2106/JBJS.L.00338. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Lumbar Spine Surgery Expectations Survey scores for patients and their surgeons.	comparison of patients and surgeons responses	participants will be surveyed before surgery, an expected average of 5 days