Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy vs Decompression Catheter in Lumbar Disc Herniation

NCT ID: NCT00300898

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2007-08-31

Brief Summary

The purpose of this study is to learn which of three minimally invasive procedures is the most effective for treatment of contained lumbar disc herniation.

Detailed Description

Contained herniation of the lumbar intervertebral disc is a frequent cause of leg and back pain. Over the last decade, there is a tendency to shift from surgical treatment of the intervertebral disc including laminectomy/discectomy to an excess of nonoperative management. Three techniques introduced recently are used as minimally invasive treatments for decompression of contained herniation of the nucleus pulposus. Nucleoplasty uses Coblation® radiofrequency vaporization of nuclear tissue to decompress the intervertebral disc. Catheter disc decompression uses heat from a resistive coil positioned in the area of disc herniation while Dekompressor® uses volume reduction to decrease an intradiscal pressure.

This is a comparison study which investigates if intervertebral electrothermal disc decompression produces better pain relief measured on VAS scale, improvement in functional capacity, return to work and opioid use, than nucleoplasty or percutaneous disc decompression (Dekompressor) of the lumbar intervertebral disc in a prospective randomized controlled study. Patients will be randomized into four treatment groups in equal numbers. The first group will be treated using nucleoplasty, the second will receive Dekompressor® lumbar disc decompression, the third will receive thermal treatment using decompression catheter (Achutherm TM) and the forth will be the control group. The control group will be treated conservatively using medications including gabapentin, a breakthrough opioid (oxycodone 5 mg 1-2 tablets q 4-6 hours as needed), NSAID, epidural steroid injections and physical therapy.

Patients will be followed and assessed at one, three, six, nine and twelve months following the procedure using VAS scores, Oswestry and SF-36 Short Form questionnaires, opioid use and return to work evaluation.

Conditions

Herniated Disc

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nucleoplasty

Procedure/Surgery: Nucleoplasty

Group Type: ACTIVE_COMPARATOR

Nucleoplasty

Intervention Type: PROCEDURE

Percutaneous decompression

Procedure/Surgery: Percutaneous decompression

Group Type: ACTIVE_COMPARATOR

Percutaneous decompression

Intervention Type: PROCEDURE

Electrothermal disc decompression (IDET)

Procedure/Surgery: Intervertebral electrothermal disc decompression (IDET)

Group Type: ACTIVE_COMPARATOR

Intervertebral electrothermal disc decompression (IDET)

Intervention Type: PROCEDURE

Behavioral:Conservative treatment

Conservative treatment with oral medications, physical therapy, epidural steroid injections

Group Type: EXPERIMENTAL

Conservative treatment

Intervention Type: BEHAVIORAL

Interventions

Nucleoplasty

Intervention Type: PROCEDURE

Percutaneous decompression

Intervention Type: PROCEDURE

Intervertebral electrothermal disc decompression (IDET)

Intervention Type: PROCEDURE

Conservative treatment

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• History of concordant radicular leg pain unresponsive to conservative treatment for longer than 3 months
• Leg pain must be greater than back pain
• Contained disc herniation as evidenced by MRI
• No evidence of psychological issues by exam or history

Exclusion Criteria

• A score of greater than 10 on Beck Depression Inventory (BDI)
• Patients with pending workers compensation claim or litigation
• Pregnancy
• Tumor
• Systemic infection or localized infection at the anticipated entry needle site
• Traumatic spinal fracture
• History of coagulopathy
• Unexplained bleeding
• Progressive neurological deficits
• History of opioid abuse or patients currently on long acting opioids
• Patients presenting with moderate or severe lumbar central or lateral canal stenosis, free disc fragments or degenerative disc disease as described on MRI

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonardo Kapural, MD, OhD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Foundation, Pain Management Department

Other Identifiers

IRB 8006

Identifier Type: -

Identifier Source: org_study_id