Lumbar Spine Disc Herniation
Conditions
Keywords
contained herniated lumbar discs, TDD, Case series, RCT
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURETargeted disc decompression
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;
Sponsors
NeuroTherm
Rijnstate Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Mono radicular leg pain for at least 6 weeks as a result from a lumbar contained herniated disc. Leg pain must be of greater impact then concomitant back-pain * Failing conservative treatment; analgesics and/or physical therapy ( WHO 1-3). Failing means persisting pain leading to problems with daily activities. * MRI: must be performed \< 6 weeks before start treatment. On MRI signs of contained herniated disc, maximum 33% obliteration of the spinal channel. No signs of other significant spine pathology (see
Exclusion criteria
). * Negative response to a transforaminal epidural injection. Injection must be performed \< 6 weeks before start treatment but least 2 weeks before start treatment * Neurological investigation by neurologist. Symptoms should be clinical related to the disc herniation level. * Age \>18 and \< 50 years * Mean pain on visual analogue scale (VAS) \>50 mm (0 -100)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary end point is pain after 3 months measured by the 10 point Jensen's visual analogy scale | 3 months after treatment | 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. |
Secondary
| Measure | 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 |
| 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 |
Countries
Netherlands
Outcome results
None listed