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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Herniated Disc

Intervention / Treatment
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* Procedure: Nucleoplasty
* Procedure: Percutaneous decompression
* Procedure: Intervertebral electrothermal disc decompression (IDET)
* Behavioral: Conservative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contained lumbar herniated disc, nucleoplasty, percutaneous decompression, Dekompressor, intervertebral electrothermal disc decompression, IDET