Efficacy of Navigable Percutaneous Plasma Disc Decompression Device (L'DISQ) in Patients With Severe Lumbar Disc Herniation

NCT05231759 | Unknown

• 1 other identifier: K2021-2858-001
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to assess the clinical outcome of percutaneous disc decompression using the L'DISQ in patients with severe lumbar disc herniation (LDH).

Conditions

Lumbar Disc Herniation

Keywords

Low Back Pain; Percutaneous Decompression; Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS)

  VAS (Visual Analogue Scale) is a measuring tool that can quickly and easily measure the level of pain through the patient's expression or attitude.

  Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure.

Secondary Outcomes (5)

• Straight Leg Raise Test (SLRT)

  Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure

• Roland-Morris Disability Questionnaire (RMDQ)

  Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure

• Oswestry Disability Index (ODI)

  Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure

• Physical Component Score (PCS) of Short Form-36 version 2 (SF-36v2)

  Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure

• Bodily Pain Score (BPS) of Short Form-36 version 2 (SF-36v2)

  Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure

Study Arms (1)

Navigable Percutaneous Plasma Disc Decompression (L'DISQ)

The L'DISQ (U\&I Co., Uijeongbu, Korea) is one of the minimally invasive disc decompression procedures which was introduced in 2011. The L'DISQ uses a navigable tip and flexible handle allowing resection of the posterolateral or posterior median disc tissue without thermal damage.

Device: L'DISQ

Interventions

L'DISQ DEVICE

Navigable Percutaneous Plasma Disc Decompression (L'DISQ)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have visited the spine center of Korea University Anam Hospital and received the L'DISQ procedure between March 01, 2009 and February 28, 2019

You may qualify if:

• single-level LDH of MSU classification of grade 3 and refusal of spine surgery
• LBP or lower extremity pain symptoms that persisted for 3 months or more
• unresponsiveness to sufficient conservative treatments, including oral analgesics, physical modalities, or spinal injections (such as selective nerve root blocks)
• limited activities of daily living due to pain.

You may not qualify if:

• patients lost during the 1-year follow-up
• evidence of peripheral neuropathy on electromyography, which might cause lower extremity pain
• evidence of vertebral fracture in the X-ray analysis
• history of tumor or myelopathy
• history of spinal surgery
• history of coagulopathy

Sponsors & Collaborators

• Korea University Anam Hospital: lead

MeSH Terms

Conditions

Intervertebral Disc Displacement; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 9, 2022
• Study Start: March 1, 2009
• Primary Completion: February 28, 2019
• Study Completion: March 31, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02