Trial record 1 of 1 for:    NCT00940810
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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
  Purpose

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.


Condition Intervention
Decompression, Surgical
Procedure: Plasma Disc Decompression/Nucleoplasty
Procedure: Conservative Care (physiotherapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Multi Center, Clinical Study With Plasma Disc Decompression Versus Conservative Care

Further study details as provided by ArthroCare Corporation:

Primary Outcome Measures:
  • 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 ]

Enrollment: 46
Study Start Date: August 2007
Study Completion Date: November 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PDD procedure 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.

Active Comparator: Conservative Care 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.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940810

Locations
Finland
Raahe Hospital
Raahe, Finland, 92100
Sweden
Storängskliniken
Stockholm, Sweden, 115 42
United Kingdom
Pallium Reseach Group; Pain Management, L Ward Seacroft Hospital
Leeds, United Kingdom
Sponsors and Collaborators
ArthroCare Corporation
  More Information

No publications provided

Responsible Party: ArthroCare Corporation
ClinicalTrials.gov Identifier: NCT00940810     History of Changes
Other Study ID Numbers: PDDCC-001
Study First Received: July 15, 2009
Last Updated: July 10, 2012
Health Authority: Sweden: Medical Products Agency
Finland: Finnish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on August 19, 2014