Lumbar Spine DegenerationDPROIPLDDALFNCT04781517
Development of a Patient-reported Outcome Instrument for Patients With Lumbar Degenerative Disease After Lumbar Fusion
An observational study of Lumbar Spine Degeneration, run by Peking University Third Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Spine Degeneration
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of Lumbar Spine Degeneration
- Plan for or have undergone lumbar fusion
- Be willing to participate in this research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Li Zhang, B.S, 18811778979, 1835591174@qq.com
About this study
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.
Read the 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.
- Conditions
- Lumbar Spine Degeneration
- Keywords
- lumbar spine, questionnaire, patient reported outcome measures, quality of life, lumbar fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Short-segment group | Lumbar degenerative diseases' patients,whose lumbar fixed segments less than 3 was divided into Short-segment group(200). | |
| Long-segment group | Lumbar degenerative diseases' patients,whose lumbar fixed segments no less than 3 was divided into Long-segment group(200). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In 7 days before lumbar fusion
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.
Measured: In 7 days before lumbar fusion
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.
Measured: In 7 days before lumbar fusion
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.
Measured: 6 months after lumbar fusion
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.
Measured: 6 months after lumbar fusion
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.
Measured: 6 months after lumbar fusion
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.
Measured: 12 months after lumbar fusion
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.
Measured: 12 months after lumbar fusion
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.
Measured: 12 months after lumbar fusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 May 2020
- Primary completion1 Mar 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine DegenerationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weishi Li, PhD, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781517
- Sponsor's protocol ID
- LDDAFQ-PRO
- Acronym
- DPROIPLDDALF
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect the personal information of patients, there is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Patient-reported Outcome Instrument for Patients With Lumbar Degenerative Disease After Lumbar Fusion
- ClinicalTrials.gov ID
- NCT04781517
- Acronym / sponsor ID
- DPROIPLDDALF / LDDAFQ-PRO
- Conditions
- Lumbar Spine Degeneration
- Keywords
- lumbar spine, questionnaire, patient reported outcome measures, quality of life, lumbar fusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-segment group | – | –Lumbar degenerative diseases' patients,whose lumbar fixed segments less than 3 was divided into Short-segment group(200). |
| Long-segment group | – | –Lumbar degenerative diseases' patients,whose lumbar fixed segments no less than 3 was divided into Long-segment group(200). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Clinical diagnosis of Lumbar Spine Degeneration
- Plan for or have undergone lumbar fusion
- Be willing to participate in this research
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Oswestry Disability Index (ODI)
Time frame: In 7 days before lumbar fusion
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.
The Japanese Orthopedic Association score(JOA-29)
Time frame: In 7 days before lumbar fusion
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.
The novel PRO instrument
Time frame: In 7 days before lumbar fusion
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.
The Oswestry Disability Index (ODI)
Time frame: 6 months after lumbar fusion
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.
The Japanese Orthopedic Association score(JOA-29)
Time frame: 6 months after lumbar fusion
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.
The novel PRO instrument
Time frame: 6 months after lumbar fusion
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.
The Oswestry Disability Index (ODI)
Time frame: 12 months after lumbar fusion
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.
The Japanese Orthopedic Association score(JOA-29)
Time frame: 12 months after lumbar fusion
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.
The novel PRO instrument
Time frame: 12 months after lumbar fusion
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No. In order to protect the personal information of patients, there is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weishi Li, PhD study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spine Degeneration, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weishi Li, PhD (15611908864, wslee@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Oswestry Disability Index (ODI) (time frame: In 7 days before lumbar fusion). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.