Plasma Disc Decompression Versus Conservative Care
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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 |
- 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 |
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| 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 | |
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 May 22, 2013