Clinical trial NCT04781517: Development of a Patient-reported Outcome Instrument for Patients With Lumbar Degenerative Disease After Lumbar Fusion
Official title: Development of a Patient-reported Outcome Instrument for Patients With Lumbar Degenerative Disease After Lumbar Fusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Spine Degeneration
Keywords: lumbar spine
questionnaire
patient reported outcome measures
quality of life
lumbar fusion
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with lumbar degenerative diseases,planning or undergone their first lumbar fusion,are willing to participate in this research.They have no neurological diseases, severe cervical/thoracic spine disease or other diseases which seriously affect their quality of life, and haven't suffered lumbar trauma after lumbar fusion.

Brief summary: The commonly used scales (ODI+JOA-29+VAS) lack the assessment of lumbar stiffness, and there is no scale for evaluating lumbar stiffness in China.Based on the Delphi method and the analytic hierarchy process, this study will improve and optimize the quality of life evaluation system for patients with severe degenerative lumbar disease, so as to obtain a concise, practical, and effective patient-reported outcome instrument.

Detailed description: Although lumbar fusion can improve function by correcting deformity,restoring spinal stability,and reducing pain, it also by intention leads to spinal stiffness which can impair function of daily activities.The commonly used scales (ODI+JOA-29+VAS) lack the assessment of lumbar stiffness.Lumbar Stiffness Disability Index (LSDI) has not been used widely, and there is no scale for evaluating lumbar stiffness in China.In addition, even if LSDI is modified, there is still an evaluation dilemma: after lumbar long-segment fixation, the pain and neurological function-related scale scores show that the quality of life is improved, while the lumbar stiffness-related scale scores show that the quality of life is reduced . So overall, is the patient's quality of life improved or decreased? Simply combining these two types of scales cannot explain clearly.

This study can be roughly divided into the following 5 main steps:

Step 1:Collect and sort out the dimensions and exhaustive items that affect the patients' quality of life by systematically reviewing the related literature and a qualitative interview study.

Step 2: Through a cross-sectional survey and experts' meetings, the items is initially optimized, and 35-45 items will be retained.

Step 3: Screen 20-25 excellent items by 2-3 rounds of Delphi method, then use the analytic hierarchy process to determine the weight of each item, so as to establish a initial PRO instrument.

Step 4: Verify the reliability and validity of the initial PRO instrument, and further optimize the initial PRO instrument in order to be used in clinical practice and research.

Step 5: Verify the responsiveness of the initial PRO instrument, calculate the ES, SRM, AUC and MICD values of the initial PRO instrument.

Finally, a novel, concise, practical, and effective PRO instrument for use in degenerative lumbar disease patients will be established.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Lumbar Spine Degeneration
* Plan for or have undergone lumbar fusion
* Be willing to participate in this research

Exclusion Criteria:

* Combined with neurological disease such as Motor neuron disease, Progressive muscular dystrophy, Peripheral neuropathy, Spinal cord disease, et al.
* Combined with severe cervical/thoracic spine disease or other diseases that seriously affect the quality of life
* Suffer lumbar spine trauma after lumbar fusion
* Preoperative cases exclude patients who plan for revision surgery
* Be unwilling to participate in this research

Primary outcomes:
measure: The Oswestry Disability Index (ODI)
timeFrame: In 7 days before lumbar fusion
measure: The Japanese Orthopedic Association score(JOA-29)
timeFrame: In 7 days before lumbar fusion
measure: The novel PRO instrument
timeFrame: In 7 days before lumbar fusion
measure: The Oswestry Disability Index (ODI)
timeFrame: 6 months after lumbar fusion
measure: The Japanese Orthopedic Association score(JOA-29)
timeFrame: 6 months after lumbar fusion
measure: The novel PRO instrument
timeFrame: 6 months after lumbar fusion
measure: The Oswestry Disability Index (ODI)
timeFrame: 12 months after lumbar fusion
measure: The Japanese Orthopedic Association score(JOA-29)
timeFrame: 12 months after lumbar fusion
measure: The novel PRO instrument
timeFrame: 12 months after lumbar fusion
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Weishi Li, PhD
role: STUDY_CHAIR
References: