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Clinical Trial Summary

In the last several decades, many Patient Reported Outcomes Measures (PROMs) have been developed to provide assessment of patient health across multiple domains, as they relate to various spine conditions. However, many of the available PROM surveys have many questions and require substantial time to complete and/or assess one focal domain of health requiring multiple tools to achieve an overall assessment of well-being. Thus, concerns have arisen regarding patient survey fatigue and data integrity. The Single Assessment Numeric Evaluation (SANE) is a single-question outcome measure that asks patients to rate their function, as it pertains to the area being treated, on a scale of 0 to 100. The SANE score has excellent acceptance in some orthopedic surgery research, where it has been shown responsiveness similar to more comprehensive legacy measures. The SANE thus eliminates survey fatigue and has been validated across a spectrum of orthopedic subspecialties. To our knowledge, however, the SANE has never been studied in a patient population undergoing any type of spinal surgery. Thus, we set out to compare the SANE score in patients undergoing lumbar discectomy to currently utilized PROM scores, including the Oswestry Disability Index (ODI), Zurich Claudication Scale (ZCS), and short form-36 (SF-36).


Clinical Trial Description

Background/Rational: In the last several decades, many Patient Reported Outcomes Measures (PROMs) have been developed to provide assessment of patient health across multiple domains, as they relate to various spine conditions. When considered in concert, these instruments quantify and stratify an individual's health state before and after surgery and can be utilized to perform research as well as inform clinical practice. However, many of the available PROM surveys have many questions and require substantial time to complete and/or assess one focal domain of health requiring multiple tools to achieve an overall assessment of well-being. Thus, concerns have arisen regarding patient survey fatigue and data integrity. Ideally, a PROM would provide sufficient information to define health status longitudinally, while requiring the least amount of time and effort to complete. The current approach to PROMs in spine surgery research has been mostly to require an assessment of pain, disease specific disability and general health, requiring answers for up to of 40 unique questions, despite efforts to shorten the questionnaires in other neurosurgery and orthopedics disciplines. The Single Assessment Numeric Evaluation (SANE) score is one such example of a limited question survey that aims to assess multiple domains. The SANE is a single-question outcome measure that asks patients to rate their function, as it pertains to the area being treated, on a scale of 0 to 100. The SANE score has excellent acceptance in some orthopedic surgery research, where it has been shown responsiveness similar to more comprehensive legacy measures. The SANE thus eliminates survey fatigue and has been validated across a spectrum of orthopedic subspecialties. To our knowledge, however, the SANE has never been studied in a patient population undergoing any type of spinal surgery. Thus, we set out to compare the SANE score in patients undergoing lumbar discectomy to currently utilized PROM scores, including the Oswestry Disability Index (ODI), Zurich Claudication Scale (ZCS), and short form-36 (SF-36). Design: Survey research design, prospective outcomes measure validation study. Objectives: We hypothesized that the SANE score would correlate strongly and demonstrate similar magnitudes of longitudinal responsiveness with the more lengthy and burdensome legacy PROMs used in spine surgery research today. Primary Objective: To correlate and confirm that SANE score to the more lengthy and burdensome legacy PROMs used in spine surgery research today. Secondary Objective: There are multiple secondary aims of this study as shown below. 1. Evaluate patients' satisfaction after surgery. 2. Assess efficacy of treatment over time. 3. Evaluate patients' sense of functional improvement after lumbar disc procedures. Information gained from this study will greatly enhance our ability to know whether SANE correlates with PROMS. Although the results of the trial will not directly benefit all the individuals participating, information gathered from this study can help future patients by reducing the burden of completing lengthy surveys and minimizing survey fatigue. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05070078
Study type Observational
Source Windsor-Essex Compassionate Care Community
Contact Mohamed Soliman, MD
Phone 306-203-9686
Email [email protected]
Status Not yet recruiting
Phase
Start date November 10, 2021
Completion date November 10, 2022

See also
  Status Clinical Trial Phase
Completed NCT00152152 - Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery N/A
Completed NCT04236050 - Continuous Infusion and Bolus Doses of Rocuronium During Lumbal Discectomy, Muscle Strength and Patient Recovery N/A