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Efficiency of Surgical Treatment for Lumbar Spinal Stenosis

NCT ID: NCT03365401

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-02-01

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.

Conditions

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Lumbar Spinal Stenosis

Keywords

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surgery decompression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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grade 1

Decompression surgery

Group Type EXPERIMENTAL

decompression surgery

Intervention Type PROCEDURE

undertake decompression surgery

grade 2

nonsurgical treatment

Group Type ACTIVE_COMPARATOR

nonsurgical treatment

Intervention Type PROCEDURE

complete on bed with prevention of complication

Interventions

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decompression surgery

undertake decompression surgery

Intervention Type PROCEDURE

nonsurgical treatment

complete on bed with prevention of complication

Intervention Type PROCEDURE

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liu Haiying

department of spinal surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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haiying liu

Role: STUDY_DIRECTOR

pekingUPH department of spinal surgery

Central Contacts

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chen guo

Role: CONTACT

Phone: 8618055644700

Email: [email protected]

Other Identifiers

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LSS011

Identifier Type: -

Identifier Source: org_study_id