Plasma Disc Decompression Versus Conservative Care

Sponsor

ArthroCare Corporation (Other)

Overall Status

Completed

CT.gov ID

NCT00940810

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

15.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Decompression, Surgical	Procedure: Plasma Disc Decompression/Nucleoplasty Procedure: Conservative Care (physiotherapy)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomized, Controlled, Multi Center, Clinical Study With Plasma Disc Decompression Versus Conservative Care

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Pain status change assessed using a visual analogue scale (VAS) for radicular pain intensity. [8 weeks post treatment start]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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

Sponsors and Collaborators

ArthroCare Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ArthroCare Corporation

ClinicalTrials.gov Identifier:

NCT00940810

Other Study ID Numbers:

PDDCC-001

First Posted:

Jul 16, 2009

Last Update Posted:

Aug 26, 2015

Last Verified:

Aug 1, 2015

Study Results

No Results Posted as of Aug 26, 2015