- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00940810
Plasma Disc Decompression Versus Conservative Care
A Prospective, Randomized, Controlled, Multi Center, Clinical Study With Plasma Disc Decompression Versus Conservative Care
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Raahe, Finland, 92100
- Raahe Hospital
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Stockholm, Sweden, 115 42
- Storängskliniken
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Leeds, United Kingdom
- Pallium Reseach Group; Pain Management, L Ward Seacroft Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PDD procedure
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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
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Pain status change assessed using a visual analogue scale (VAS) for radicular pain intensity.
Time Frame: 8 weeks post treatment start
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8 weeks post treatment start
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PDDCC-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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