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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nucleoplasty | Active Comparator | Procedure/Surgery: Nucleoplasty |
|
| Percutaneous decompression | Active Comparator | Procedure/Surgery: Percutaneous decompression |
|
| Electrothermal disc decompression (IDET) | Active Comparator | Procedure/Surgery: Intervertebral electrothermal disc decompression (IDET) |
|
| Behavioral:Conservative treatment | Experimental | Conservative treatment with oral medications, physical therapy, epidural steroid injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleoplasty | Procedure |
| ||
| Percutaneous decompression |
| Measure | Description | Time Frame |
|---|---|---|
| VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months | baseline 1, 3, 6, 9, 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonardo Kapural, MD, OhD | Cleveland Clinic Foundation, Pain Management Department | Principal Investigator |
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|
| Intervertebral electrothermal disc decompression (IDET) | Procedure |
|
| Conservative treatment | Behavioral |
|
| 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 |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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