Plasma Disc Decompression Versus Conservative Care
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|ClinicalTrials.gov Identifier: NCT00940810|
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : August 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Decompression, Surgical||Procedure: Plasma Disc Decompression/Nucleoplasty Procedure: Conservative Care (physiotherapy)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Controlled, Multi Center, Clinical Study With Plasma Disc Decompression Versus Conservative Care|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2011|
|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.
- Pain status change assessed using a visual analogue scale (VAS) for radicular pain intensity. [ Time Frame: 8 weeks post treatment start ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940810
|Raahe, Finland, 92100|
|Stockholm, Sweden, 115 42|
|Pallium Reseach Group; Pain Management, L Ward Seacroft Hospital|
|Leeds, United Kingdom|