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

Lumbar Disc Herniation Clinical Trial

— L'DISQ  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05231759
• Other study ID #: K2021-2858-001
• Status: Active, not recruiting
• Start date: March 1, 2009
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2022
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Description:

Low back pain (LBP) is one of the most leading cause of chronic pain worldwide and 70-85% of adults have experienced LBP during their lifetime. The one of most common symptom of lumbar disc herniation (LDH) is sciatica, affecting about 1-5% of people worldwide. Almost two thirds of patients suffer from continuous pain even after 12 months of the first episode of LBP. Moreover, such persistent pain reduces the patient's quality of life and increases the social and economic burden due to increased hospital stay and surgical treatment. Traditionally, the primary treatment of LDH is non-surgical treatment including pain medication, rehabilitation exercise, and spinal injection, and about 70% of the patients show improvement of pain within 4 weeks. Surgical treatment is considered if there are neurological symptoms such as bladder dysfunction or progressive muscle weakness, or if symptoms persist for more than 6 weeks despite conservative treatment.

The patients with LDH usually experience sudden onset of LBP with radiating pain to lower extremity. Sensory symptoms such as focal paresis or motor weakness of specific myotome can also occur in the LDH patients. The symptoms and area of pain can vary due to the herniation level and severity. Michigan State University (MSU) classification was often used to evaluate and select for surgical treatment of LDH patients. In this classification, the herniated disc is evaluated using T2 axial magnetic resonance imaging (MRI) scan and classified by its size and location. The size of disc herniation is classified into 1 (*<50% of the distance to the intra-facet line), 2 (intra-facet line>*≥50% of the distance to the intra-facet line), or 3 (beyond intra-facet line). Then the position is classified in to A (central), B (lateral), or C (far lateral). The disc herniations size 3 (beyond intra-facet line) and zone B (lateral) or C (far lateral) are known to have greater impact on nerve compression, which tend to cause worse sciatica and neurologic symptoms and require surgical treatment. Moreover, the patients with larger lumbar disc herniation areas tend to show better outcomes with surgical treatment than conservative treatments and high-grade spinal canal stenosis patients had higher need for surgical treatment.

Over the past few years, various minimally invasive disc decompression procedures, were developed and used in LDH patients. These minimally invasive disc decompression techniques include intradiscal electrothermal therapy, radiofrequency annuloplasy, percutaneous disc decompression, nucleoplasty, and percutaneous laser disc decompression, which caused less damage to spinal structures and reduced tissue destructions than conventional surgical treatments. In particular, nucleoplasty was proven as effective as open discectomy in the treatment of single level lumbar disc herniation. The L'DISQ (U&I Co., Uijeongbu, Korea) is one of the safe and effective minimally invasive disc decompression procedures which introduced in 2011. In contrast to most percutaneous nucleotomy procedures that used rigid tip, the L'DISQ used a navigable tip and flexible handle allowing resection of the posterolateral or posterior median disc tissue without thermal damage.

The L'DISQ can be mainly performed in patients with less severe LDH while surgical treatment was mainly indicated in patients with severe LDH with neurologic symptoms. However, surgical treatment such as lumbar discectomy or spinal fusion increase hospitalization time and may increase financial burden of patients. And spinal fusion surgery might lead to delayed complications such as back muscle weakness or adjacent segment disease. Moreover, patients with severe LDH might refuse or not be able to perform surgery due to medical, financial, or other personal reasons. Recently, studies on the efficacy of L'DISQ or plasma decompression in disc patients are being conducted, and shows similar outcome when compared to surgical treatment in mild to moderate disc herniation patients. However, no studies have been conducted on the efficacy of L'DISQ in patients with severe LDH requiring surgical treatment. Purpose of this study is to report the efficacy of the L'DISQ procedure in patients with severe LDH corresponding to MSU classification 3.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 31, 2022
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. single-level LDH of MSU classification of grade 3 and refusal of spine surgery

2. LBP or lower extremity pain symptoms that persisted for 3 months or more

3. unresponsiveness to sufficient conservative treatments, including oral analgesics, physical modalities, or spinal injections (such as selective nerve root blocks)

4. limited activities of daily living due to pain.

Exclusion Criteria:

1. patients lost during the 1-year follow-up

2. evidence of peripheral neuropathy on electromyography, which might cause lower extremity pain

3. evidence of vertebral fracture in the X-ray analysis

4. history of tumor or myelopathy

5. history of spinal surgery

6. history of coagulopathy

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation

Intervention

Device:
• L'DISQ

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Straight Leg Raise Test (SLRT)	The SLRT is a test that measures the initial angle at which the patient complains of lower extremity radiating pain during the passive hip flexion with knee extended in supine position. Normal people show hip flexion angle of 80 to 90 degrees, but the hip flexion angle at the initiationg of pain is reduced in LDH patients due to nerve irritation at the level of disc prolapse	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	Roland-Morris Disability Questionnaire (RMDQ)	The RMDQ is used to evaluate physical disability caused by low back pain and its score range from 0 to 24. The higher score means greater level of disability	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	Oswestry Disability Index (ODI)	The ODI is used to assess chronic low back pain symptoms and is consisted of 10 questions. The ODI score can result from 0 to 100% and higher score also means greater level of disabilities.	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	Physical Component Score (PCS) of Short Form-36 version 2 (SF-36v2)	The PCS is component of SF-36v2. The SF-36v2 is a short-form survey for evaluating health status including physical and mental factors. The PCS shows summary of physical component. It can be scored from 0 to 100 and higher scores indicates better health status.	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	Bodily Pain Score (BPS) of Short Form-36 version 2 (SF-36v2)	The BPS is component of SF-36v2. The SF-36v2 is a short-form survey for evaluating health status including physical and mental factors. The BPS shows summary of bodily pain component. It can be scored from 0 to 100 and higher scores indicates better health status.	Change from baseline data, evaluated during the hospitalization prior to the L'DISQ procedure, to 4, 12, 24, and 48 weeks after the procedure