Efficiency of Surgical Treatment for Lumbar Spinal Stenosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Surgical Treatment Versus Nonoperative Treatment in Lumbar Spinal Stenosis: a Multicenter Open-label Randomized Controlled Trial

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Procedure: decompression surgery
* Procedure: nonsurgical treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: grade 1<br>Decompression surgery | Procedure: decompression surgery<br>* undertake decompression surgery<br>|
| Active Comparator: grade 2<br>nonsurgical treatment | Procedure: nonsurgical treatment<br>* complete on bed with prevention of complication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of symptoms | Oswestry disability index (ODI) | 6, 12, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of pain relief | World Health Organization pain classification | 6, 12, and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, decompression