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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDD procedure | Experimental |
| |
| Conservative Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma Disc Decompression/Nucleoplasty | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain status change assessed using a visual analogue scale (VAS) for radicular pain intensity. | 8 weeks post treatment start |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raahe Hospital | Raahe | 92100 | Finland | |||
| Storängskliniken |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Conservative Care (physiotherapy) | Procedure | 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. |
|
| Stockholm |
| 115 42 |
| Sweden |
| Pallium Reseach Group; Pain Management, L Ward Seacroft Hospital | Leeds | United Kingdom |