Plasma Disc Decompression Versus Conservative Care

Study Overview
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Brief Summary
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The purpose of this study is to compare the plasma disc decompression (PDD) procedure to conservative care (physiotherapy) for the treatment of patients with radicular pain originating from a disc protrusion. Treatment efficacy and rate of improvement is evaluated at 8 weeks after treatment start and followed-up for 1 year after treatment start.

Official Title
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A Prospective, Randomized, Controlled, Multi Center, Clinical Study With Plasma Disc Decompression Versus Conservative Care

Conditions
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Decompression, Surgical

Intervention / Treatment
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* Procedure: Plasma Disc Decompression/Nucleoplasty
* Procedure: Conservative Care (physiotherapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has one symptomatic contained, focal herniated lumbar disc. Patient's age should be at least 18 years old and no more than 65 years old. A VAS score for radicular pain of 50 or greater on a scale of 0 to 100. Radicular pain concordant with image findings (MRI/CT not older than 12 months). Disc height greater or equal to 50% of expected height in the range of a patient's normal anatomic variations and expected changes due to age. Patient signs informed consent. Exclusion Criteria: Patient is pregnant, or pregnancy is suspected or planned within the study timeframe. Patient has a cardiac pacemaker, automatic defibrillator, or any peripheral stimulator leads in the lumbar area. Allergy to contrast media or drugs to be used in the intended procedure. Medical co-morbidities that preclude surgical intervention. Patient is receiving anti-psychotic therapy. Patient is a prisoner. Patient is incapable of understanding or responding to the study questionnaires. History of previous spinal surgery at, or directly adjacent to, the level to be treated. Patient is morbidly obese (BMI ≥ 40). Patient is simultaneously participating in another device or drug study related to limb/axial pain. Patient has a spinal fracture, tumor or infection. Radicular pain originating from more than one disc level. Axial (back) pain greater than radicular (leg) pain. Clinical evidence of cauda equina syndrome. Progressive neurologic deficit. Radiological evidence of spondylolisthesis at the level to be treated. Radiological evidence of moderate/severe stenosis at the level to be treated. Evidence of extruded or sequestered disc herniation on magnetic resonance imaging.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: PDD procedure<br> | Procedure: Plasma Disc Decompression/Nucleoplasty<br>* Subjects assigned to the PDD Group will be scheduled to receive the plasma disc decompression procedure using the Coblation® method. Similarly to in Conservative Care group, subjects will be followed-up at 2, 8 weeks, 6 and 12 months (calculated from the date of the PDD procedure). The follow-up visits will consist of a brief physical examination in the clinic and completion of study questionnaires.<br>|
| Active Comparator: Conservative Care<br> | Procedure: Conservative Care (physiotherapy)<br>* Subjects assigned to the Conservative Care Group will be scheduled to receive physical therapy according to standard and customary care locally. Subjects will be followed-up at 2, 8 weeks, 6 and 12 months . (Calculated from the time of first going through the individual training programme).The follow-up visits will consist of a brief physical examination in the clinic and completion of study questionnaires.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain status change assessed using a visual analogue scale (VAS) for radicular pain intensity. |  | 8 weeks post treatment start |