Development of a Patient-reported Outcome Instrument for Patients With Lumbar Degenerative Disease After Lumbar Fusion

Lumbar Spine Degeneration Clinical Trial

— DPROIPLDDALF  

Official title:

Development of a Patient-reported Outcome Instrument for Patients With Lumbar Degenerative Disease After Lumbar Fusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04781517
• Other study ID #: LDDAFQ-PRO
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: February 2021
• Source: Peking University Third Hospital
• Contact: Weishi Li, PhD
• Phone: 15611908864
• Email: wslee[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Spine Degeneration

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Oswestry Disability Index (ODI)	Use the Oswestry Disability Index (ODI) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of ODI score is 0 and the maximum value is 50. Higher ODI scores mean a worse outcome.	In 7 days before lumbar fusion
Primary	The Japanese Orthopedic Association score(JOA-29)	Use the Japanese Orthopedic Association score(JOA-29) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of JOA-29 score is 0 and the maximum value is 29. Higher JOA-29 scores mean a better outcome.	In 7 days before lumbar fusion
Primary	The novel PRO instrument	Use the novel PRO instrument to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of the novel PRO instrument score is 0 and the maximum value is 100. Higher the novel PRO instrument scores mean a worse outcome.	In 7 days before lumbar fusion
Primary	The Oswestry Disability Index (ODI)	Use the Oswestry Disability Index (ODI) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of ODI score is 0 and the maximum value is 50. Higher ODI scores mean a worse outcome.	6 months after lumbar fusion
Primary	The Japanese Orthopedic Association score(JOA-29)	Use the Japanese Orthopedic Association score(JOA-29) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of JOA-29 score is 0 and the maximum value is 29. Higher JOA-29 scores mean a better outcome.	6 months after lumbar fusion
Primary	The novel PRO instrument	Use the novel PRO instrument to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of the novel PRO instrument score is 0 and the maximum value is 100. Higher the novel PRO instrument scores mean a worse outcome.	6 months after lumbar fusion
Primary	The Oswestry Disability Index (ODI)	Use the Oswestry Disability Index (ODI) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of ODI score is 0 and the maximum value is 50. Higher ODI scores mean a worse outcome.	12 months after lumbar fusion
Primary	The Japanese Orthopedic Association score(JOA-29)	Use the Japanese Orthopedic Association score(JOA-29) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of JOA-29 score is 0 and the maximum value is 29. Higher JOA-29 scores mean a better outcome.	12 months after lumbar fusion
Primary	The novel PRO instrument	Use the novel PRO instrument to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of the novel PRO instrument score is 0 and the maximum value is 100. Higher the novel PRO instrument scores mean a worse outcome.	12 months after lumbar fusion