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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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.
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.
Raahe Hospital
Raahe, Finland
Storängskliniken
Stockholm, Sweden
Pallium Reseach Group; Pain Management, L Ward Seacroft Hospital
Leeds, United Kingdom
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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