Plasma Disc Decompression Versus Conservative Care

ArthroCare

Status: Completed

Conditions: Decompression, Surgical

Treatments: Procedure: Conservative Care (physiotherapy); Procedure: Plasma Disc Decompression/Nucleoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00940810

PDDCC-001

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient has one symptomatic contained, focal herniated lumbar disc.
2. Patient's age should be at least 18 years old and no more than 65 years old.
3. A VAS score for radicular pain of 50 or greater on a scale of 0 to 100.
4. Radicular pain concordant with image findings (MRI/CT not older than 12 months).
5. 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.
6. Patient signs informed consent.

Exclusion criteria

1. Patient is pregnant, or pregnancy is suspected or planned within the study timeframe.
2. Patient has a cardiac pacemaker, automatic defibrillator, or any peripheral stimulator leads in the lumbar area.
3. Allergy to contrast media or drugs to be used in the intended procedure.
4. Medical co-morbidities that preclude surgical intervention.
5. Patient is receiving anti-psychotic therapy.
6. Patient is a prisoner.
7. Patient is incapable of understanding or responding to the study questionnaires.
8. History of previous spinal surgery at, or directly adjacent to, the level to be treated.
9. Patient is morbidly obese (BMI ≥ 40).
10. Patient is simultaneously participating in another device or drug study related to limb/axial pain.
11. Patient has a spinal fracture, tumor or infection.
12. Radicular pain originating from more than one disc level.
13. Axial (back) pain greater than radicular (leg) pain.
14. Clinical evidence of cauda equina syndrome.
15. Progressive neurologic deficit.
16. Radiological evidence of spondylolisthesis at the level to be treated.
17. Radiological evidence of moderate/severe stenosis at the level to be treated.
18. Evidence of extruded or sequestered disc herniation on magnetic resonance imaging.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

PDD procedure

Experimental group

Treatment:

Procedure: Plasma Disc Decompression/Nucleoplasty

Conservative Care

Active Comparator group

Treatment:

Procedure: Conservative Care (physiotherapy)