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

Herniated Disc Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00300898
• Other study ID #: IRB 8006
• Status: Withdrawn
• Phase: N/A
• Start date: July 2006
• Est. completion date: August 2007

Study information

• Verified date: May 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 54 Years

Eligibility

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

Related Conditions & MeSH terms

• Herniated Disc
• Intervertebral Disc Displacement

Intervention

Procedure:
• Nucleoplasty

• Percutaneous decompression

• Intervertebral electrothermal disc decompression (IDET)

Behavioral:
• Conservative treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months		baseline 1, 3, 6, 9, 12 months
Secondary	Oswestry results	Disability Index	baseline 1, 3, 6, 9, 12 months
Secondary	Quality of Life SF-36	SF-36 score at baseline 1, 3, 6, 9, 12 months	baseline 1, 3, 6, 9, 12 months
Secondary	Return to work evaluation	Return to work evaluation	1 month
Secondary	Depression score	Beck Depression Inventory score at pre-treatment visit	BASELINE
Secondary	Opioid use	Opioid use	1, 3, 6, 9, 12 months