Efficiency of Surgical Treatment for Lumbar Spinal Stenosis

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03365401

Enrollment

150

Registered

2017-12-07

Start date

2018-02-01

Completion date

2020-02-01

Last updated

2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Stenosis

Keywords

surgery, decompression

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.

Interventions

PROCEDUREdecompression surgery

undertake decompression surgery

PROCEDUREnonsurgical treatment

complete on bed with prevention of complication

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
change of symptoms	6, 12, and 24 months	Oswestry disability index (ODI)

Secondary

Measure	Time frame	Description
change of pain relief	6, 12, and 24 months	World Health Organization pain classification

Contacts

Primary Contactchen guo

fantasy_g@163.com8618055644700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026