Back to resultsEfficiency of Surgical Treatment for Lumbar Spinal Stenosis
Primary Purpose
Lumbar Spinal Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
decompression surgery
nonsurgical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring surgery, decompression
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
grade 1
grade 2
Arm Description
Decompression surgery
nonsurgical treatment
Outcomes
Primary Outcome Measures
change of symptoms
Oswestry disability index (ODI)
Secondary Outcome Measures
change of pain relief
World Health Organization pain classification
Full Information
NCT ID
NCT03365401
First Posted
December 2, 2017
Last Updated
December 2, 2017
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03365401
Brief Title
Efficiency of Surgical Treatment for Lumbar Spinal Stenosis
Official Title
Surgical Treatment Versus Nonoperative Treatment in Lumbar Spinal Stenosis: a Multicenter Open-label Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Anticipated)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This study will use a randomised controlled trial to access the efficiency of the surgery for degenerated LSS. Patients aged 50 years or older, had LSS will be invited to take part. Patients will be randomised divided into 2 arms. The participants in the intervention arm will have decompression surgery ; those randomised to the control arm will receive current standard conservative treatment methods.
Patients were clinically assessed at baseline (the day of surgery or treatment), and at 6,12 and 24 months afterwards. The primary outcome will be the pain release , categorised according to Oswestry disability index.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
surgery, decompression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
grade 1
Arm Type
Experimental
Arm Description
Decompression surgery
Arm Title
grade 2
Arm Type
Active Comparator
Arm Description
nonsurgical treatment
Intervention Type
Procedure
Intervention Name(s)
decompression surgery
Intervention Description
undertake decompression surgery
Intervention Type
Procedure
Intervention Name(s)
nonsurgical treatment
Intervention Description
complete on bed with prevention of complication
Primary Outcome Measure Information:
Title
change of symptoms
Description
Oswestry disability index (ODI)
Time Frame
6, 12, and 24 months
Secondary Outcome Measure Information:
Title
change of pain relief
Description
World Health Organization pain classification
Time Frame
6, 12, and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chen guo
Phone
8618055644700
Email
fantasy_g@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
haiying liu
Organizational Affiliation
pekingUPH department of spinal surgery
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficiency of Surgical Treatment for Lumbar Spinal Stenosis
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