Efficiency of Surgical Treatment for Lumbar Spinal Stenosis
Surgical Treatment Versus Nonoperative Treatment in Lumbar Spinal Stenosis: a Multicenter Open-label Randomized Controlled Trial
1 other identifier
interventional
150
0 countries
N/A
Brief Summary
Decompression surgery has proved to be effective for Lumbar Spinal Stenosis (LSS) with persistent pain. But the efficiency of the surgery for degenerated LSS remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to surgical group or a nonoperative group. Because of the procedure , neither patients nor investigators were blinded. The primary outcome is the change of symptom measure by the Oswestry disability index 6, 12, and 24 months after procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2017
CompletedFirst Posted
Study publicly available on registry
December 7, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedDecember 7, 2017
December 1, 2017
2 years
December 2, 2017
December 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change of symptoms
Oswestry disability index (ODI)
6, 12, and 24 months
Secondary Outcomes (1)
change of pain relief
6, 12, and 24 months
Study Arms (2)
grade 1
EXPERIMENTALDecompression surgery
grade 2
ACTIVE COMPARATORnonsurgical treatment
Interventions
Eligibility Criteria
You may qualify if:
- Clinical symptoms: back pain radiation to lower limbs or buttocks; fatigue or loss of sensation in the lower limbs aggravated by walking.
- Persistent pain without progressive neurologic dysfunction
- Duration of symptoms and signs for more than 6 months
- Severity of the disease justifying either surgical or nonoperative treatment
You may not qualify if:
- severe LSS with intractable pain and progressive neurologic dysfunction, suggesting forthcoming surgical treatment
- spinal stenosis not caused by degeneration
- lumbar herniated disc diagnosed during the last 12 months
- neurologic disease causing impaired function of the lower limbs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
haiying liu
pekingUPH department of spinal surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- department of spinal surgery
Study Record Dates
First Submitted
December 2, 2017
First Posted
December 7, 2017
Study Start
February 1, 2018
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
December 7, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share