Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| NeuroTherm | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The prospective Clinical Series (CS) aims to prove the hypothesis that Targeted Disc Decompression (TDD) reduces the pain in patients suffering from radicular leg pain secondary to a contained focal disc protrusion (Lumboradicular Syndrome). Secondary objective will be to prove that the treatment Group will have less disability and better quality of life.
The study will start with a prospective clinical series (CS) in which 20 patients after careful selection will be treated with TDD, followed by a standardized rehabilitation program. After the diagnosis Lumboradicular syndrome the patient will first receive an transforaminal epidural injection at the site and level of the herniated disc, proven on MRI. Two weeks after the epidural injection the patient is evaluated. When the response is negative (a decrease less than 2.5 points on the 10 points VAS scale) TDD can be performed. Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 months after the study intervention. End point of this study is 3 months after TDD treatment. A positive response is defined as a minimal decrease of 2.5 points on the 10 points VAS scale compared to the VAS score at baseline.
A positive response in at least seven patients and acceptable side-effects and complications will lead to the start of a RCT.
If the response is positive < 7 out of 20 patients, the decision to proceed with a RCT following the prospective CS is made after evaluation of the CS by a team of experts. The results from this prospective study will be published.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted disc decompression | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted disc decompression | Procedure | The Targeted disc catheter is connected to Neurotherm TDD unit and heating protocol is started.In this heating protocol temperature gradually increases from 65C to 90C during a time period of 12 minutes; |
| Measure | Description | Time Frame |
|---|---|---|
| Primary end point is pain after 3 months measured by the 10 point Jensen's visual analogy scale | Primary end point is pain after 3 months measured by the 10 point Jensen's visual analogy scale. Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 months by a Anesthesiologist and the research nurse - both blinded for the performed procedure. | 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| MPQ-DLV (second pain measurement) | Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 | |
| Quebec Back Pain Disability Scale (disability) | Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| JW Kallewaard, Drs. | Rijnsate Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | 6800 TA | Netherlands | ||
| Diakonessenhuis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rand-36 (quality of live) | Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 |
| 7-point Likert scale (global perceived effect) | Patient outcome will be evaluated at 6 weeks, 3, 6, 12 and 24 |
| Utrecht |
| Utrecht |
| 3508 TG |
| Netherlands |
| Rijnland Ziekenhuis | Leiderdorp | 2350 CC | Netherlands |