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

Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy (Dekompressor) vs Decompression Catheter for the Treatment of Painful Contained Lumbar Disc Herniation: A Prospective Randomized Controlled Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Herniated Disc
• Intervention / Treatment: Procedure: Nucleoplasty; Procedure: Percutaneous decompression; Procedure: Intervertebral electrothermal disc decompression (IDET); Behavioral: Conservative treatment

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 52 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nucleoplasty; Procedure/Surgery: Nucleoplasty	Procedure: Nucleoplasty
Active Comparator: Percutaneous decompression; Procedure/Surgery: Percutaneous decompression	Procedure: Percutaneous decompression
Active Comparator: Electrothermal disc decompression (IDET); Procedure/Surgery: Intervertebral electrothermal disc decompression (IDET)	Procedure: Intervertebral electrothermal disc decompression (IDET)
Experimental: Behavioral:Conservative treatment; Conservative treatment with oral medications, physical therapy, epidural steroid injections	Behavioral: Conservative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months	baseline 1, 3, 6, 9, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry results	Disability Index	baseline 1, 3, 6, 9, 12 months
Quality of Life SF-36	SF-36 score at baseline 1, 3, 6, 9, 12 months	baseline 1, 3, 6, 9, 12 months
Return to work evaluation	Return to work evaluation	1 month
Depression score	Beck Depression Inventory score at pre-treatment visit	BASELINE
Opioid use	Opioid use	1, 3, 6, 9, 12 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Leonardo Kapural, MD, OhD, Cleveland Clinic Foundation, Pain Management Department

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2006
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: March 8, 2006
• First Submitted That Met QC Criteria: March 8, 2006
• First Posted (Estimate): March 10, 2006

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: nucleoplasty; contained lumbar herniated disc; percutaneous decompression; Dekompressor; intervertebral electrothermal disc decompression; IDET
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: IRB 8006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No