Plasma Disc Decompression Versus Conservative Care

NCT ID: NCT00940810

Last Updated: 2015-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-11-30

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 protrusion. Treatment efficacy and rate of improvement is evaluated at 8 weeks after treatment start and followed-up for 1 year after treatment start.

Conditions

Decompression, Surgical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PDD procedure

Group Type: EXPERIMENTAL

Plasma Disc Decompression/Nucleoplasty

Intervention Type: PROCEDURE

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.

Conservative Care

Group Type: ACTIVE_COMPARATOR

Conservative Care (physiotherapy)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ArthroCare Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Raahe Hospital

Raahe, , Finland

Storängskliniken

Stockholm, , Sweden

Pallium Reseach Group; Pain Management, L Ward Seacroft Hospital

Leeds, , United Kingdom

Countries

Finland; Sweden; United Kingdom

Other Identifiers

PDDCC-001

Identifier Type: -

Identifier Source: org_study_id