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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| grade 1 | Experimental | Decompression surgery |
|
| grade 2 | Active Comparator | nonsurgical treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| decompression surgery | Procedure | undertake decompression surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change of symptoms | Oswestry disability index (ODI) | 6, 12, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| change of pain relief | World Health Organization pain classification | 6, 12, and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chen guo | Contact | 8618055644700 | fantasy_g@163.com |
| Name | Affiliation | Role |
|---|---|---|
| haiying liu | pekingUPH department of spinal surgery | Study Director |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007796 | Laminectomy |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
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| nonsurgical treatment |
| Procedure |
complete on bed with prevention of complication |
|
| D019635 | Neurosurgical Procedures |