Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial

Seoul National University Hospital64 enrolled

Overview

This study is to compare the clinical outcome between the biportal endoscopic decompression and the unilateral approach bilateral decompression in spinal stenosis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Degenerative Lumbar Spinal Stenosis

Interventions

BESSPROCEDURE

Biportal endoscopic surgery

ULBDPROCEDURE

Unilateral laminotomy bilateral decompression

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients aged between 30 and 80 * patients who has radiating pain (VAS \>=40) on lower extremities with spinal stenosis over Gr B * patients who required one-level decompression between L1 and S1 * those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form Exclusion Criteria: * Revision surgery * Over spondylolisthesis Gr II * Degenerative lumbar scoliosis (Cobb angle \>20) * herniated disc * patients with a history of other spinal diseases (compression fracture, spondylitis, tumor) * women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years * patients with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study) * patients with mental retardation or whose parents or legal guardians were older or had mental disabilities * other patients viewed as inappropriate by the staff

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyounggido, South Korea

Outcomes

Primary Outcomes

Oswestry disability index (ODI)

The ODI is based on a self-administered questionnaire measuring ''back-specific function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores ranges from 0 to 100, with higher scores indicating severe symptoms. This is assessed by ODI survey at 1 year after surgery

Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation

Secondary Outcomes

Visual Analog Pain Scale (VAS)

VAS is a measurement score that indicates pain severity status. VAS score comprised a 10-cm line with ''none'' (0) on one end of the scale and ''disabling pain'' (10) on the other.

Time frame: 4, 8, 12, 24, 48 hours, 2 weeks, 3, 6, and 12, months, and every year, up to 5 year after operation

EQ-5D

EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.

Time frame: 3, 6, and 12, months, and every year, up to 5 year after operation

PainDETECT

The painDETECT Questionnaire (PDQ) is a screening tool designed to detect neuropathic pain in patients with chronic low back pain (LBP) based on self-reported pain characteristics. The degree of the seven types of pain quality, the type of pain pattern, and the presence of radiating pain. From the three components of the PDQ, a total score is calculated; a high score indicates that the pain is likely to have a neuropathic component. Scoring is performed using a scoring manual, and results in a final screening score: a score of 0-12 indicates nociceptive pain, 19-38 indicates neuropathic pain, and 13-18 indicates mixed pain.

Data from ClinicalTrials.gov

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