Plasma Disc Decompression Versus Conservative Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ArthroCare Corporation
ClinicalTrials.gov Identifier:
NCT00940810
First received: July 15, 2009
Last updated: July 10, 2012
Last verified: July 2012

July 15, 2009
July 10, 2012
August 2007
November 2010   (final data collection date for primary outcome measure)
Pain status change assessed using a visual analogue scale (VAS) for radicular pain intensity. [ Time Frame: 8 weeks post treatment start ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00940810 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Plasma Disc Decompression Versus Conservative Care
A Prospective, Randomized, Controlled, Multi Center, Clinical Study With Plasma Disc Decompression Versus Conservative Care

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Decompression, Surgical
  • Procedure: Plasma Disc Decompression/Nucleoplasty

    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.

  • Procedure: Conservative Care (physiotherapy)

    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.

  • Experimental: PDD procedure
    Intervention: Procedure: Plasma Disc Decompression/Nucleoplasty
  • Active Comparator: Conservative Care
    Intervention: Procedure: Conservative Care (physiotherapy)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
November 2011
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Finland,   Sweden
 
NCT00940810
PDDCC-001
No
ArthroCare Corporation
ArthroCare Corporation
Not Provided
Not Provided
ArthroCare Corporation
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP