Plasma Disc Decompression Versus Conservative Care
|ClinicalTrials.gov Identifier: NCT00940810|
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : August 26, 2015
|Condition or disease||Intervention/treatment|
|Decompression, Surgical||Procedure: Plasma Disc Decompression/Nucleoplasty Procedure: Conservative Care (physiotherapy)|
|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|
|Primary Completion Date :||November 2010|
|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 ]
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|