Status:
COMPLETED
Plasma Disc Decompression Versus Conservative Care
Lead Sponsor:
ArthroCare Corporation
Conditions:
Decompression, Surgical
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00940810
Start Date
August 1 2007
End Date
November 1 2011
Last Update
August 26 2015
Active Locations (3)
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1
Raahe Hospital
Raahe, Finland, 92100
2
Storängskliniken
Stockholm, Sweden, 115 42
3
Pallium Reseach Group; Pain Management, L Ward Seacroft Hospital
Leeds, United Kingdom